Trial Outcomes & Findings for Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (NCT NCT04000009)

NCT ID: NCT04000009

Last Updated: 2022-04-05

Results Overview

Number of patients with treatment emergent AEs

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 235 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2022-04-05

Participant Flow

The study recruited patients that had completed a previous study of pimavanserin, i.e. either study ACP-103-054 or ACP-103-059. It was planned to enroll about 420 patients in total. The study was terminated early by the Sponsor for business reasons due to the COVID-19 pandemic; there were no safety concerns contributing to study termination (see Caveats and Limitations). A total of 235 patients were enrolled and treated instead of the anticipated number of about 420 patients.

During the screening period, subjects were assessed for study eligibility and prohibited medications were discontinued when medically appropriate.

Participant milestones

Measure	Pimavanserin Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
Overall Study STARTED	235
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	165

Reasons for withdrawal

Measure	Pimavanserin Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
Overall Study Adverse Event	13
Overall Study Lack of Efficacy	7
Overall Study Lost to Follow-up	8
Overall Study Noncompliance with study drug	4
Overall Study Physician Decision	1
Overall Study Use of prohibited medication	3
Overall Study Pregnancy	1
Overall Study Withdrawal by Subject	22
Overall Study Study terminated by sponsor	98
Overall Study Not further specified	8

Baseline Characteristics

Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Baseline characteristics by cohort

Measure	Pimavanserin n=235 Participants Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
Age, Continuous	45.5 years STANDARD_DEVIATION 13.90 • n=5 Participants
Sex: Female, Male Female	165 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	219 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	111 participants n=5 Participants
Region of Enrollment Finland	10 participants n=5 Participants
Region of Enrollment Ukraine	26 participants n=5 Participants
Region of Enrollment Poland	16 participants n=5 Participants
Region of Enrollment South Africa	1 participants n=5 Participants
Region of Enrollment United Kingdom	27 participants n=5 Participants
Region of Enrollment Slovakia	5 participants n=5 Participants
Region of Enrollment Serbia	13 participants n=5 Participants
Region of Enrollment Russia	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: All patients enrolled who received at least one dose of study medication

Number of patients with treatment emergent AEs

Outcome measures

Measure	Pimavanserin n=235 Participants Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
Treatment-emergent Adverse Events (TEAEs)	137 Participants

Adverse Events

Pimavanserin

Serious events: 5 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pimavanserin n=235 participants at risk Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
Gastrointestinal disorders Diverticular perforation	0.43% 1/235 • Number of events 1 • 52 weeks
Gastrointestinal disorders Gastrointestinal obstruction	0.43% 1/235 • Number of events 1 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.43% 1/235 • Number of events 1 • 52 weeks
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.43% 1/235 • Number of events 1 • 52 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.43% 1/235 • Number of events 1 • 52 weeks

Other adverse events

Measure	Pimavanserin n=235 participants at risk Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
Gastrointestinal disorders Diarrhoea	5.1% 12/235 • Number of events 13 • 52 weeks
Infections and infestations Nasopharyngitis	6.4% 15/235 • Number of events 17 • 52 weeks
Infections and infestations Urinary tract infection	5.1% 12/235 • Number of events 12 • 52 weeks
Investigations Weight increased	6.0% 14/235 • Number of events 14 • 52 weeks
Nervous system disorders Headache	12.3% 29/235 • Number of events 39 • 52 weeks

Additional Information

Sr. Dir. Medical Information and Medical Communications

Acadia Pharmaceuticals Inc.

Phone: 858-261

Email: medicalinformation@acadia-pharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator may publish the study results, relative to their own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the Sponsor for review and comment. The sponsor has 60 days to review and comment.
• Publication restrictions are in place

Restriction type: OTHER