Trial · NCT03121586
Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
NCT03121586, Phase 3, Terminated, ACADIA Pharmaceuticals Inc.; results first posted 2025-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia. Trials, record NCT03121586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03121586
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
- NCT number
- NCT03121586
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 995 participants, actual
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Conditions
- Schizophrenia
- Interventions
- Pimavanserin
- First posted
- 2017-04-20
- Last updated
- 2025-08-24
- Other registries' IDs
- eudract:2016-003435-38
- Results first posted
- 2025-08-24
- Limitations and caveats
- The study was terminated prematurely by the sponsor for business reasons.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Emergent Adverse Events | Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks). | Number of patients with treatment emergent adverse events |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Emergent Adverse Events | Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks). | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Emergent Adverse Events | Rollover From ACP-103-034 | 128 | Participants | ||
| Treatment Emergent Adverse Events | Rollover From ACP-103-038 | 111 | Participants | ||
| Treatment Emergent Adverse Events | Rollover From ACP-103-064 | 110 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rollover From ACP-103-034 | 323 | |
| Overall Study | STARTED | Rollover From ACP-103-038 | 325 | |
| Overall Study | STARTED | Rollover From ACP-103-064 | 347 | |
| Overall Study | COMPLETED | Rollover From ACP-103-034 | 248 | |
| Overall Study | COMPLETED | Rollover From ACP-103-038 | 280 | |
| Overall Study | COMPLETED | Rollover From ACP-103-064 | 217 | |
| Overall Study | NOT COMPLETED | Rollover From ACP-103-034 | 75 | |
| Overall Study | NOT COMPLETED | Rollover From ACP-103-038 | 45 | |
| Overall Study | NOT COMPLETED | Rollover From ACP-103-064 | 130 |
Source ClinicalTrials.gov
Adverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Rollover From ACP-103-034 | 21 | 323 | 23 |
| other | Headache | Nervous system disorders | Rollover From ACP-103-038 | 30 | 325 | 36 |
| other | Headache | Nervous system disorders | Rollover From ACP-103-064 | 19 | 347 | 24 |
| serious | Dental cyst | Gastrointestinal disorders | Rollover From ACP-103-034 | 0 | 323 | 0 |
| serious | Dental cyst | Gastrointestinal disorders | Rollover From ACP-103-038 | 1 | 325 | 1 |
| serious | Dental cyst | Gastrointestinal disorders | Rollover From ACP-103-064 | 0 | 347 | 0 |
| serious | Chest pain | General disorders | Rollover From ACP-103-034 | 1 | 323 | 1 |
| serious | Chest pain | General disorders | Rollover From ACP-103-038 | 0 | 325 | 0 |
| serious | Chest pain | General disorders | Rollover From ACP-103-064 | 0 | 347 | 0 |
| serious | Drowning | General disorders | Rollover From ACP-103-034 | 1 | 323 | 1 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rollover From ACP-103-034 | 2 | 323 |
| Total, all-cause mortality | Rollover From ACP-103-038 | 0 | 325 |
| Total, all-cause mortality | Rollover From ACP-103-064 | 0 | 347 |
| Total, other adverse events | Rollover From ACP-103-034 | 21 | 323 |
| Total, other adverse events | Rollover From ACP-103-038 | 30 | 325 |
| Total, other adverse events | Rollover From ACP-103-064 | 19 | 347 |
| Total, serious adverse events | Rollover From ACP-103-034 | 13 | 323 |
| Total, serious adverse events | Rollover From ACP-103-038 | 4 | 325 |
| Total, serious adverse events | Rollover From ACP-103-064 | 4 | 347 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03121586
GET https://conductscience.org/api/trials/v1/NCT03121586/events?page=2