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Clinical trials
catalyst calendar across sponsors →Studies where ACAD 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.
39 interventional · 1 observational · 1 expanded access · 29 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension StudyNCT06194799Treatment-emergent adverse eventsOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: ACP-204 | Alzheimer's Disease Psychosis | 752 | Apr 2029 | ≤ 985 d | 2026-08-05 |
| Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia PsychosisNCT07095465Proportion of subjects who experience treatment-emergent adverse events (TEAEs)Open-label · Treatment | Phase 3 | Enrolling by invitation | Drug: ACP-204 | Lewy Body Dementia Psychosis | 126 | Feb 2029 | ≤ 924 d | 2026-07-24 |
| Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia PsychosisNCT07029581Change from Baseline in SAPS-LBDP total score at Week 6Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: ACP-204, Placebo | Lewy Body Dementia Psychosis | 180 | Feb 2028 | ≤ 559 d | 2026-07-24 |
| ACP-204 in Adults With Alzheimer's Disease PsychosisNCT06159673Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)Randomized · Quadruple-masked · Treatment | Phase 2/3 | Recruiting | Drug: ACP-204, Placebo | Alzheimer's Disease Psychosis | 1,074 | Jan 2028 | ≤ 530 d | 2026-07-24 |
| ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant ResponseNCT07284667Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: ACP-211, Placebo | Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant | 153 | Aug 2027 | ≤ 377 d | 2026-08-06 |
| Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi SyndromeNCT06173531Change from Baseline at Week 12 in caregiver-rated Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scoreRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Carbetocin, Placebo | Hyperphagia in Prader-Willi Syndrome | 170 | Oct 2025 | — | 2025-09-10 |
| OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi SyndromeNCT06420297Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctionsOpen-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Primary efficacy endpoint was not met in the parent study (ACP-101-302). Based on review of available data, continued administration of investigational product in ACP-101-303 was not considered likely to provide significant clinical benefit. | Drug: Carbetocin | Hyperphagia in Prader-Willi Syndrome | 168 | 2025-12-19actual | — | 2026-08-17 |
| Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum DisorderNCT05555615results2025-12-03Treatment-emergent Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: The study was terminated for business reasons and not due to safety concerns. | Drug: Pimavanserin | Irritability Associated With Autism Spectrum Disorder | 209 | 2025-02-14actual | — | 2025-12-03 |
| Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum DisorderNCT05523895results2025-08-24Change From Baseline at Week 6 in Caregiver-rated Aberrant Behavior Checklist Irritability (ABC-I) Subscale ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: Pimavanserin, Placebo | Irritability Associated With Autism Spectrum Disorder | 237 | 2024-09-27actual | — | 2025-08-24 |
| Extension Study of Pimavanserin for the Adjunctive Treatment of SchizophreniaNCT03121586results2025-08-24Treatment Emergent Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminated | Drug: Pimavanserin | Schizophrenia | 995 | 2024-04-30actual | — | 2025-08-24 |
| Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of SchizophreniaNCT04531982results2025-04-01Negative Symptom Assessment-16 (NSA-16) Total Score - Change From Baseline to Week 26Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pimavanserin, Placebo | Schizophrenia | 454 | 2024-01-25actual | — | 2025-08-22 |
| Open-Label Extension Study of Trofinetide for Rett SyndromeNCT04776746results2024-09-27Percentage of Patients With Treatment-emergent Adverse Events (TEAEs), With Serious Adverse Events (SAEs), and With Withdrawals Due to AEsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product. | Drug: trofinetide | Rett Syndrome | 77 | 2023-06-30actual | — | 2024-09-27 |
| An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett SyndromeNCT04988867results2024-09-24Safety and Tolerability of Treatment With Oral TrofinetideOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product. | Drug: Trofinetide | Rett Syndrome | 15 | 2023-05-31actual | — | 2024-09-24 |
| Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative DiseaseNCT03623321results2024-12-20Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pimavanserin | Neuropsychiatric Symptoms Related to Neurodegenerative Disease | 595 | 2023-05-05actual | — | 2024-12-20 |
| Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the KneeNCT05008835results2025-01-09Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity ScoresRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study was terminated for business reasons. | Drug: ACP-044 Dose A, ACP-044 Dose B, Placebo | Osteoarthritis Pain | 61 | 2022-10-06actual | — | 2025-01-09 |
| Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett SyndromeNCT04279314results2024-04-11Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs), Percentage of Subjects With Serious Adverse Events (SAEs), and Percentage of Subjects With Withdrawals Due to AEsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Trofinetide | Rett Syndrome | 154 | 2022-08-19actual | — | 2024-04-11 |
| A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative DiseaseNCT03575052results2024-12-31Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pimavanserin, Placebo | Neuropsychiatric Symptoms Related to Neurodegenerative Disease | 784 | 2022-05-06actual | — | 2024-12-31 |
| Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisNCT04292223results2025-01-14Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total ScoreOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Pimavanserin | Parkinson Disease Psychosis | 29 | 2022-04-26actual | — | 2025-01-14 |
| Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following BunionectomyNCT04855240results2023-05-03Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) of Pain Intensity Scores From Time 0 (When First Dose on Day 1 is Administered) Through 24 HoursRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ACP-044 Dose A, ACP-044 Dose B, Placebo | Acute Postoperative Pain, Bunionectomy | 239 | 2022-02-11actual | — | 2023-05-03 |
| Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)NCT04181723results2024-04-08Rett Syndrome Behaviour Questionnaire (RSBQ) Total Score - Change From Baseline to Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Trofinetide · Other: Placebo | Rett Syndrome | 187 | 2021-10-28actual | — | 2024-04-08 |
| The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) StudyNCT03152292observationalThe INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) | — | Terminatedsponsor's stated reason: Study follow-up duration impacted by COVID-19pandemic and Sponsor terminated for business reasons | Other: Real-world, non-interventional | Parkinson Disease Psychosis | 764 | 2021-03-08actual | — | 2021-08-06 |
| Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant TreatmentNCT04000009results2022-04-05Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The study was terminated for business reasons and not due to safety concerns. | Drug: Pimavanserin | Adjunctive Treatment of Major Depressive Disorder | 235 | 2021-02-22actual | — | 2022-04-05 |
| Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose QuetiapineNCT04164758results2021-10-14Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study enrollment impacted by COVID-19 pandemic and Sponsor terminated for business reasons | Drug: Pimavanserin, Quetiapine · Other: Placebo | Parkinson's Disease | 11 | 2020-09-25actual | — | 2021-10-14 |
| Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant TreatmentNCT03968159results2021-11-17Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol: Study ACP-103-059 protocol (NCT03968159) ↗ · Study Protocol: Study ACP-103-054 protocol (NCT03999918) ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pimavanserin, Placebo | Adjunctive Treatment of Major Depressive Disorder | 298 | 2020-04-30actual | — | 2021-11-17 |
| Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)NCT02970305results2020-12-22Change From Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Pimavanserin, Placebo | Schizophrenia | 403 | 2019-10-16actual | — | 2020-12-22 |
| Relapse Prevention Study of Pimavanserin in Dementia-related PsychosisNCT03325556results2021-06-21Time From Randomization to Relapse in the Double-blind (DB) PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, Pimavanserin 34 mg, Pimavanserin 20 mg | Dementia-related Psychosis | 392 | 2019-07-31actual | — | 2021-06-21 |
| Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and DepressionNCT03482882results2020-08-31Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total ScoreOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Pimavanserin | Treatment of Depression in Adults With Parkinson's Disease (PD) | 47 | 2019-07-09actual | — | 2020-08-31 |
| Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)NCT02970292results2020-06-17Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pimavanserin, Placebo | Schizophrenia | 396 | 2019-05-28actual | — | 2020-06-17 |
| A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's DiseaseNCT03118947results2020-03-09Treatment Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Pimavanserin | Agitation and Aggression in Alzheimer's Disease | 79 | 2019-02-25actual | — | 2020-04-09 |
| Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)NCT03018340results2019-11-14Change From Baseline to Week 5 in the HAMD-17 Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Pimavanserin · Other: Placebo | Adjunctive Treatment of Major Depressive Disorder | 207 | Sep 2018actual | — | 2019-11-14 |
| A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisNCT00550238results2019-06-24Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Pimavanserin tartrate (ACP-103) | Parkinson's Disease Psychosis | 459 | 2018-05-30actual | — | 2019-06-24 |
| Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)NCT02992132results2019-03-28Cohen-Mansfield Agitation Inventory (CMAI)Randomized · Quadruple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Terminated | Drug: Pimavanserin 34 mg, Pimavanserin 20 mg · Other: Placebo | Agitation and Aggression in Alzheimer's Disease | 111 | 2018-01-25actual | — | 2019-03-28 |
| A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease PsychosisNCT02035553results2017-10-25Antipsychotic EfficacyRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Pimavanserin tartrate, Placebo | Alzheimer's Disease Psychosis | 181 | 2016-09-28actual | — | 2017-10-25 |
| An Open-label Safety Study of Pimavanserin in Parkinson's Disease PatientsNCT01518309results2020-11-23Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)Open-label · Treatment | Phase 2 | Completed | Drug: pimavanserin tartrate (ACP-103) | Parkinson's Disease Psychosis | 39 | 2013-05-02actual | — | 2020-11-23 |
| A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease PsychosisNCT01174004results2014-03-26Antipsychotic EfficacyRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: pimavanserin tartrate, placebo | Parkinson's Disease Psychosis | 199 | Nov 2012actual | — | 2014-03-26 |
| A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisNCT00658567results2014-09-09Antipsychotic EfficacyRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Pimavanserin tartrate (ACP-103), Pimavanserin tartrate (ACP-103), Pimavanserin tartrate (ACP-103) | Parkinson's Disease Psychosis | 123 | Dec 2009actual | — | 2017-05-19 |
| A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisNCT00477672results2014-03-26Antipsychotic EfficacyRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Pimavanserin tartrate (ACP-103), Pimavanserin tartrate (ACP-103), Placebo | Parkinson's Disease Psychosis | 298 | Jun 2009actual | — | 2017-05-17 |
| ACP-104 in Acutely Psychotic Subjects With SchizophreniaNCT00490516PANSSRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ACP-104, ACP-104, Placebo | Schizophrenia | 247 | Feb 2008actual | — | 2025-01-20 |
| Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational DrugNCT00087542ACP-103 is an effective treatment for Parkinson's Disease with psychosisRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: ACP-103 | Hallucinations, Psychoses, Parkinson's Disease | 60 | — | — | 2005-12-07 |
| Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and RisperidoneNCT00361166Total score on the Positive and Negative Symptom Scale (PANSS).Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: ACP-103 | Schizophrenia | 400 | — | — | 2007-03-22 |
| Expanded Access of Pimavanserin for Patients With PD PsychosisNCT02762591expanded access | — | Approved for marketing | Drug: Pimavanserin tartrate | Parkinson's Disease Psychosis | — | — | — | 2017-04-18 |
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