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Clinical trials
catalyst calendar across sponsors →Studies where ALKS is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
79 interventional · 2 observational · 1 expanded access · 35 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic HypersomniaNCT06767683Incidence of Treatment-Emergent Adverse EventsNon-randomized · Open-label · Treatment | Phase 2/3 | Recruiting | Drug: ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg, ALKS 2680, 14mg, ALKS 2680, 18mg | Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia | 256 | Jun 2028 | ≤ 681 d | 2026-08-07 |
| Long-term Safety Extension Study of OLZ/SAM in Pediatric SubjectsNCT04987229Incidence of adverse eventsOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: OLZ/SAM | Bipolar I Disorder, Schizophrenia | 236 | Sep 2027 | ≤ 407 d | 2026-08-14 |
| A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)NCT07755410Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total scoreRandomized · Triple-masked · Treatment | Phase 2 | Recruiting | Drug: ALKS 7290, Placebo | Attention Deficit Disorder With Hyperactivity (ADHD) | 312 | Jul 2027 | ≤ 346 d | 2026-08-10 |
| A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)NCT07540897Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose levelRandomized · Triple-masked · Treatment | Phase 3 | Recruiting | Drug: ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo | Narcolepsy Type 1 | 150 | Jun 2027 | ≤ 315 d | 2026-08-07 |
| A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1NCT07455383Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose levelRandomized · Triple-masked · Treatment | Phase 3 | Recruiting | Drug: ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo | Narcolepsy Type 1 | 150 | May 2027 | ≤ 285 d | 2026-08-07 |
| A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2NCT07502443Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose levelRandomized · Triple-masked · Treatment | Phase 3 | Recruiting | Drug: ALKS 2680 Dose 1, ALKS 2680 Dose 2, ALKS 2680 Dose 3, Placebo | Narcolepsy Type 2 | 176 | May 2027 | ≤ 285 d | 2026-08-07 |
| A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic HypersomniaNCT06843590Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose levelRandomized · Double-masked · Treatment | Phase 2 | Recruiting | Drug: ALKS 2680, Placebo | Idiopathic Hypersomnia | 126 | Nov 2026 | ≤ 103 d | 2026-06-24 |
| Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I DisorderNCT05303064Change from baseline in body mass index (BMI) Zscore at week 12Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: OLZ/SAM, Olanzapine | Schizophrenia, Bipolar I Disorder | 220 | Sep 2026 | ≤ 42 d | 2026-08-14 |
| A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2NCT06555783Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ALKS 2680, Placebo | Narcolepsy Type 2 | 93 | 2025-11-11actual | — | 2026-02-27 |
| A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)NCT06358950Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ALKS 2680, Placebo | Narcolepsy Type 1 | 92 | 2025-06-19actual | — | 2026-06-10 |
| Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831NCT03201757results2024-09-26Incidence of Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 3831 | Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder | 523 | 2023-09-06actual | — | 2024-09-26 |
| Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I DisorderNCT04987658Maximum plasma concentration observedNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: OLZ/SAM | Bipolar I Disorder | 7 | 2023-08-11actual | — | 2023-11-22 |
| Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)NCT03919994observationalSchizophrenia disease history | — | Completed | — | Schizophrenia | 338 | 2023-01-04actual | — | 2023-02-02 |
| Study of the Breast Milk Pharmacokinetics of Olanzapine and SamidorphanNCT05547100Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)Open-label · Treatment | Phase 1 | Completed | Drug: LYBALVI | Focus of Study is on Healthy Lactating Women | 12 | 2022-11-19actual | — | 2023-02-10 |
| Phase 1 ALKS 1140 in Healthy AdultsNCT05019105Incidence of treatment-emergent adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: Placebo, ALKS 1140 | Central Nervous System Diseases | 20 | 2022-08-23actual | — | 2022-09-02 |
| Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I DisorderNCT03187769results2023-01-19Percent Change From Baseline in Body Weight at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 3831, Olanzapine | Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder | 426 | 2021-12-01actual | — | 2023-01-19 |
| A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)NCT03610048results2021-07-16Number of Subjects With Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: ALKS 5461 | Refractory Major Depressive Disorder | 175 | 2020-05-01actual | — | 2021-07-16 |
| A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)NCT03188185results2021-03-15Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) ScoresRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 5461, ALKS 5461 Placebo | Major Depressive Disorder | 278 | 2020-02-26actual | — | 2021-04-08 |
| A 28 Day Parallel Group Study to Assess the Effects of RDN-929NCT03963973Number of subjects with adverse eventsRandomized · Quadruple-masked · Other | Phase 1 | Terminatedsponsor's stated reason: Participants no longer receiving intervention | Drug: RDN-929 oral capsule, Placebo oral capsule | Healthy | 7 | 2020-01-22actual | — | 2020-02-20 |
| A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With SchizophreniaNCT02873208results2021-07-21Number of Subjects With Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 3831 | Schizophrenia | 266 | 2019-10-17actual | — | 2021-07-21 |
| A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic DensityNCT03577262Measure [11C]-UCB-J plasma radioactivity levels in plasma over timeNon-randomized · Open-label · Other | Early Phase 1 | Completed | Other: [11C]-UCB-J | Healthy, Alzheimer Disease | 19 | 2019-08-02actual | — | 2020-02-20 |
| Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly SubjectsNCT03668314Number of subjects with adverse eventsRandomized · Triple-masked · Other | Phase 1 | Completed | Drug: RDN-929, Placebo oral capsule, RDN-929 TBD dose, RDN-929, Placebo oral capsule | Healthy | 84 | 2019-04-15actual | — | 2020-02-20 |
| A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of SchizophreniaNCT03345979results2020-08-11Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Combination product: Aripiprazole Lauroxil · Drug: Paliperidone Palmitate | Schizophrenia | 200 | 2019-03-12actual | — | 2020-08-11 |
| A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)NCT02694328results2020-02-10Percent Change From Baseline in Body Weight at Week 24Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 3831, Olanzapine | Schizophrenia | 561 | 2018-11-07actual | — | 2020-02-10 |
| A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With SchizophreniaNCT02669758results2019-07-09Number of Participants With Adverse Events (AEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 3831 | Schizophrenia | 281 | 2018-06-29actual | — | 2019-07-26 |
| Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROLNCT02696434results2019-02-12Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Naltrexone, Placebo, Buprenorphine | Opioid Use Disorder | 101 | Nov 2017actual | — | 2019-02-12 |
| A Long-Term Safety Study of ALKS 5461NCT02141399results2018-12-14Incidence of Adverse Events (AEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 5461 | Major Depressive Disorder | 1,485 | 2017-11-20actual | — | 2018-12-14 |
| An Insulin Sensitivity Study in Healthy SubjectsNCT02922426Changes in blood glucose concentrationsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ALKS 3831, Olanzapine, Placebo | Healthy Volunteers | 60 | 2017-07-20actual | — | 2017-08-22 |
| A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With SchizophreniaNCT02634320results2018-11-08Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) ScoresOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Aripiprazole Lauroxil | Schizophrenia | 51 | 2017-07-11actual | — | 2018-12-04 |
| A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)NCT02634346results2018-06-27Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALK3831, Olanzapine, Placebo | Schizophrenia | 403 | 2017-05-25actual | — | 2018-06-27 |
| A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use DisorderNCT02161718results2021-10-08Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Samidorphan + olanzapine (ALKS 3831), Placebo + olanzapine | Schizophrenia, Alcohol Use Disorder | 300 | 2017-01-11actual | — | 2021-10-08 |
| Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)NCT02537574results2019-01-09Proportion of Subjects Who Receive and Tolerate a VIVITROL InjectionRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: NTX/BUP, NTX/PBO-B, PBO-N/PBO-B | Opioid Use Disorder | 380 | 2016-10-27actual | — | 2019-03-06 |
| A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 StudyNCT02218008results2019-03-27Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ALKS 5461, Placebo | Major Depressive Disorder | 407 | Sep 2016actual | — | 2019-08-14 |
| A Phase 1 Safety Study in Adults With SchizophreniaNCT02804568Maximum plasma concentration (Cmax)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ALKS 3831 | Schizophrenia | 42 | Aug 2016actual | — | 2016-09-22 |
| An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)NCT01895452results2017-08-25Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ALKS 9072, Low Dose, ALKS 9072, High Dose | Schizophrenia | 291 | Jun 2016actual | — | 2017-08-25 |
| A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective DisorderNCT02636842Maximum plasma concentration (Cmax)Open-label · Treatment | Phase 1 | Completed | Drug: Aripiprazole Lauroxil | Schizophrenia, Schizoaffective Disorder | 47 | Jun 2016actual | — | 2016-07-14 |
| An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable SchizophreniaNCT02320032AUC 0-lastRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Aripiprazole Lauroxil | Schizophrenia | 140 | Apr 2016actual | — | 2018-08-29 |
| A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 StudyNCT02158533results2019-03-27Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: High Dose ALKS 5461, Low Dose ALKS 5461, Placebo | Major Depressive Disorder | 385 | Dec 2015actual | — | 2019-08-14 |
| A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 StudyNCT02158546results2019-06-25Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ALKS 5461, Placebo | Major Depressive Disorder | 447 | Dec 2015actual | — | 2019-06-25 |
| Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic FunctionNCT02452801Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461Open-label · Treatment | Phase 1 | Completed | Drug: ALKS 5461 | Hepatic Impairment | 40 | Dec 2015actual | — | 2016-02-04 |
| Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal FunctionNCT02508506Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461Open-label · Treatment | Phase 1 | Completed | Drug: ALKS 5461 | Renal Impairment | 22 | Dec 2015actual | — | 2016-02-04 |
| A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy VolunteersNCT02479308Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Moxifloxacin, ALKS 5461, Placebo | Healthy | 129 | Oct 2015actual | — | 2015-11-23 |
| A Drug-drug Interaction Study of ALKS 5461 in Healthy VolunteersNCT02545439AUCinfOpen-label · Treatment | Phase 1 | Completed | Drug: ALKS 5461 | Healthy Volunteers | 24 | Oct 2015actual | — | 2015-11-10 |
| A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid UsersNCT02413281Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: ALKS 5461, Buprenorphine, Placebo | Healthy | 56 | Sep 2015actual | — | 2015-11-10 |
| A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male VolunteersNCT02504463AUC 0-tNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Samidorphan IV, [14c]-Samidorphan sublingual, [14c]-Samidorphan oral | Healthy | 10 | Sep 2015actual | — | 2015-09-18 |
| A Water Consumption Study of ALKS 5461 in Healthy VolunteersNCT02521857AUCinfOpen-label · Treatment | Phase 1 | Completed | Drug: ALKS 5461 | Healthy | 30 | Sep 2015actual | — | 2015-11-10 |
| A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)NCT01626456results2016-10-27Number of Subjects With Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ALKS 9072, Low, ALKS 9072, High | Schizophrenia | 478 | Apr 2015actual | — | 2018-09-25 |
| A Study of ALKS 3831 in Adults With SchizophreniaNCT01903837results2021-09-08Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Samidorphan (Low Dose), Samidorphan (Medium Dose), Samidorphan (High Dose), Placebo, Olanzapine | Schizophrenia | 347 | Dec 2014actual | — | 2021-10-06 |
| A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid UsersNCT02218021Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Samidorphan, Placebo, Oxycodone | Healthy Volunteers | 59 | Nov 2014actual | — | 2014-12-02 |
| A Drug-Drug Interaction Study of ALKS 5461 in Healthy VolunteersNCT02272764Drug-Drug Interaction - AUC0-tRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Itraconazole, ALKS 5461 | Pharmacokinetics | 24 | Nov 2014actual | — | 2014-12-12 |
| A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)NCT02085135results2019-03-27Number of Subjects With Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ALKS 5461 | Major Depressive Disorder | 66 | Sep 2014actual | — | 2019-08-14 |
| A Study of VIVITROL in the Prevention of Re-arrest and Re-incarcerationNCT01453374results2015-07-13Incidence of Subject Re-arrestOpen-label · Treatment | Phase 4 | Completed | Drug: VIVITROL 380mg | Opioid Dependence | 27 | May 2014actual | — | 2015-07-13 |
| A Study of ALKS 5461 in Healthy VolunteersNCT02068105Relative bioavailability of ALKS 5461 treatment groupsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ALKS 5461, Placebo | Pharmacokinetics | 104 | Mar 2014actual | — | 2014-04-21 |
| A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With SchizophreniaNCT01469039results2016-01-22The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ALKS 9072, Placebo | Schizophrenia | 623 | Jan 2014actual | — | 2019-01-30 |
| ALK21-025: Vivitrol's Cost and Treatment Outcomes RegistryNCT01422837observational | — | Completed | — | Opioid Dependence | 403 | Oct 2013actual | — | 2018-11-16 |
| A Study of ALKS 9072 in Subjects With Chronic Stable SchizophreniaNCT01493726Maximum concentration in plasma following last doseRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ALKS 9072, Low dose, ALKS 9072, Med dose, ALKS 9072, High dose, Placebo | Schizophrenia | 88 | Jun 2013actual | — | 2018-08-29 |
| A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)NCT01500200results2019-05-21Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ALKS 5461, Placebo | Major Depressive Disorder | 142 | Mar 2013actual | — | 2019-05-21 |
| ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)NCT01418092Change from baseline in the weekly average of complete spontaneous bowel movements during treatmentRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ALKS 37, Placebo | OIC | 91 | Jun 2012actual | — | 2012-08-07 |
| ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care ProfessionalsNCT00834080results2013-07-29Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.Open-label · Treatment | Phase 3 | Completed | Drug: Medisorb naltrexone 380 mg | Opiate Dependence | 38 | May 2012actual | — | 2018-12-11 |
| ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)NCT01382797Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ALKS 37, Placebo | Opioid-induced Constipation | 157 | Apr 2012actual | — | 2012-06-13 |
| Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic SurgeryNCT01436032Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24)Randomized · Quadruple-masked · Treatment | Phase 3 | Terminated | Drug: N1539, N1539, N1539, Ketorolac Tromethamine, Placebo | Laparoscopic Surgery | 50 | Mar 2012actual | — | 2012-03-14 |
| ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With CocaineNCT01366001The primary outcome measures are safety and pharmacokinetics (PK)/ pharmacodynamics (PD)Randomized · Quadruple-masked | Phase 1 | Completed | Drug: ALKS 33-BUP, ALKS 33, Placebo | Cocaine Abuse | 33 | Feb 2012actual | — | 2012-03-09 |
| ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDDNCT01381107The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461)Randomized · Triple-masked | Phase 1/2 | Completed | Drug: ALKS 5461, Placebo | Major Depressive Disorder | 32 | Jul 2011actual | — | 2011-08-23 |
| ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating DisorderNCT01098435Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: RDC-0313 (ALKS 33), Placebo | Binge Eating Disorder | 69 | May 2011actual | — | 2011-08-23 |
| ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced AbstinenceNCT00501631results2011-04-13Cumulative Percentage of Participants by Heavy Drinking RateRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: VIVITROL 380 mg, Placebo for VIVITROL 380 mg | Alcohol Dependence | 300 | Jan 2011actual | — | 2011-09-22 |
| Study to Evaluate the Efficacy, Safety and Tolerability of N1539NCT01084161To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: N1539, N1539, N1539, N1539, placebo, Morphine, N1539 | Hysterectomy | 486 | Jan 2011actual | — | 2011-12-02 |
| ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)NCT01100151Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment periodRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: RDC-1036 (ALKS 37), Placebo | Opioid-induced Constipation | 60 | Dec 2010actual | — | 2011-08-23 |
| ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol DependenceNCT00981617Percent of subjects abstinent from heavy drinkingRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ALKS33 (RDC-0313) (1 mg), ALKS33 (RDC-0313) (2.5 mg), ALKS33 (RDC-0313) (10 mg), Placebo | Alcohol Dependence | 406 | Aug 2010actual | — | 2011-08-23 |
| Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction SurgeryNCT00945763Pain Intensity Difference at End of StudyRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: N1539, placebo, N1539, N1539, Motrin | Dental Pain | 230 | Nov 2009actual | — | 2011-12-02 |
| ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid DependenceNCT00678418results2011-01-21Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: VIVITROL® 380 mg, Placebo | Opiate Dependence | 250 | Oct 2009actual | — | 2017-02-10 |
| ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent AdultsNCT00511836results2010-12-07Change From Baseline in Blood Oxygen-level-dependent (BOLD) Signal Activation Values Detected in the Reward Circuitry of the Brain in Alcohol-dependent Subjects After Presentation of Alcohol-related Cues.Randomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: VIVITROL 380 mg, Placebo | Alcohol Dependence | 31 | Jun 2009actual | — | 2017-07-11 |
| ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPDNCT00801684results2011-05-10Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Placebo, TrIP-2D, TrIP-2SS, TrIP-2D, TrIP-2SS + Foradil | Chronic Obstructive Pulmonary Disease (COPD) | 24 | Apr 2009actual | — | 2011-08-19 |
| ALK33-001: A Study of RDC-0313 Administered to Healthy AdultsNCT00800319Maximum plasma concentrations (Cmax) of RDC-0313Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: RDC-0313, Placebo | Alcohol Dependence | 16 | Feb 2009actual | — | 2011-08-22 |
| ALK29-002: A Study of Baclofen Formulations in Healthy AdultsNCT00802035Maximum plasma concentration (Cmax)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Baclofen IR, Baclofen ER | Alcohol Dependence | 16 | Dec 2008actual | — | 2011-08-23 |
| ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent AdultsNCT00156923results2010-12-03Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Medisorb naltrexone 380 mg, Medisorb naltrexone 190 mg | Alcoholism | 108 | Jan 2007actual | — | 2017-07-11 |
| ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])NCT00156936results2010-11-03Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.Non-randomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Business decision | Drug: Medisorb naltrexone 380 mg, Oral naltrexone to Medisorb naltrexone 380 mg | Alcoholism, Opiate Dependence | 108 | Jan 2007actual | — | 2010-11-17 |
| ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)NCT01218997results2010-12-13Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on StudyRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Medisorb naltrexone 380 mg, Oral naltrexone 50 mg | Alcoholism | 436 | Mar 2005actual | — | 2011-01-04 |
| ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)NCT01218971results2010-12-08Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in StudyNon-randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg | Alcohol Dependence | 332 | Sep 2004actual | — | 2010-12-24 |
| ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent AdultsNCT01218958results2010-12-07Percentage of Heavy Drinking Days Over the Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg, Placebo matching Medisorb naltrexone 190 mg, Placebo matching Medisorb naltrexone 380 mg | Alcoholism | 624 | Sep 2003actual | — | 2017-07-11 |
| ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use OpioidsNCT01218984results2010-12-13Slope Change From Baseline for Pupil SizeRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Medisorb naltrexone 75 mg, Medisorb naltrexone 150 mg, Medisorb naltrexone 300 mg, Hydromorphone (10 mg/mL), Naloxone Challenge and Oral Naltrexone Tolerability Testing | Opiate Dependence | 27 | May 2003actual | — | 2017-01-11 |
| The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal MeningitisNCT00002316Double-masked · Treatment | Phase 1 | Completed | Drug: Lobradimil, Amphotericin B | Meningitis, Cryptococcal, HIV Infections | — | — | — | 2005-06-24 |
| An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)NCT07744113expanded access | — | Available | Drug: OLZ/SAM | Bipolar 1 Disorder, Schizophrenia Disorder | — | — | — | 2026-08-04 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19