Trial Outcomes & Findings for Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder (NCT NCT04188392)
NCT ID: NCT04188392
Last Updated: 2022-08-31
Results Overview
The rate of enrollment per month; goal of 6 subjects total
COMPLETED
PHASE4
6 participants
Total duration of recruitment time (5.8 months)
2022-08-31
Participant Flow
Subjects recruited from clinics and clinician referrals at the Michael E. DeBakey VA Medical Center
Pre-assignment exclusions (n=5): non-adherent to CPAP (n=2), bradycardia and hepatic dysfunction (n=1), psychosis (n=1), lost to follow up (n=1)
Participant milestones
| Measure |
Open-label Treatment
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
Sleep Studies 1 and 2
|
6
|
|
Overall Study
Mid-point Visit (Treatment Week-3)
|
6
|
|
Overall Study
Sleep Study 3
|
5
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Open-label Treatment
n=6 Participants
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.33 years
STANDARD_DEVIATION 6.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
|
Current depressive disorder
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Total duration of recruitment time (5.8 months)Population: Subjects enrolled into open label treatment
The rate of enrollment per month; goal of 6 subjects total
Outcome measures
| Measure |
Open-label Treatment
n=6 Participants
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Recruitment Rates
|
1.03 participants enrolled per month
Interval 0.38 to 2.25
|
PRIMARY outcome
Timeframe: 10 weeks (overall study)Population: Subjects enrolled into open-label treatment
The number of subjects who complete the protocol in its entirety; goal of 75% of subjects enrolled into treatment
Outcome measures
| Measure |
Open-label Treatment
n=6 Participants
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Retention Rates
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 weeks (time between baseline and closeout polysomnogram)Population: Subjects enrolled in open-label treatment and completed baseline and post-treatment polysomnogram (1 subject could not complete post-treatment polysomnogram due to pandemic).
The mean difference in duration of stage N3 sleep from baseline polysomnogram to week-6 polysomnogram (\[Time in N3 post-treatment\] - \[Time in N3 at baseline polysomnogram\])
Outcome measures
| Measure |
Open-label Treatment
n=5 Participants
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Mean Change in Duration of Stage N3 Sleep Pre- and Post-treatment
|
21.7 minutes
Standard Deviation 39.57
|
SECONDARY outcome
Timeframe: 10 weeks (overall study duration)Population: Number of subjects enrolled into open-label treatment
The number of subjects who discontinue the protocol due to adverse effects (from either protocol or medication)
Outcome measures
| Measure |
Open-label Treatment
n=6 Participants
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Discontinuation Rates Due to Adverse Effects
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 weeks (overall study duration)Population: Subjects enrolled into open-label treatment
The percentage of participants who complete subject and objective measures of insomnia, including sleep diaries, actigraphy, and attended polysomnography
Outcome measures
| Measure |
Open-label Treatment
n=6 Participants
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Completion Rates of Key Outcome Measures
Completed sleep study 1
|
6 Participants
|
|
Completion Rates of Key Outcome Measures
Completed sleep study 2
|
6 Participants
|
|
Completion Rates of Key Outcome Measures
Completed sleep study 3
|
5 Participants
|
|
Completion Rates of Key Outcome Measures
At least 4 days of actigraphy pre-treatment
|
6 Participants
|
|
Completion Rates of Key Outcome Measures
At least 4 days of actigraphy post-treatment
|
6 Participants
|
|
Completion Rates of Key Outcome Measures
At least 4 days of sleep diary pre-treatment
|
6 Participants
|
|
Completion Rates of Key Outcome Measures
At least 4 days of sleep diary post-treatment
|
6 Participants
|
Adverse Events
Open-label Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-label Treatment
n=6 participants at risk
pimavanserin 34mg at bedtime for 6 weeks
Pimavanserin: pimavanserin tablet
|
|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
16.7%
1/6 • 10 weeks
Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment
|
|
General disorders
sleepiness
|
33.3%
2/6 • 10 weeks
Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment
|
|
General disorders
dry mouth
|
16.7%
1/6 • 10 weeks
Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment
|
|
Nervous system disorders
headache
|
16.7%
1/6 • 10 weeks
Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
16.7%
1/6 • 10 weeks
Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment
|
|
Gastrointestinal disorders
diarrhea
|
16.7%
1/6 • 10 weeks
Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment
|
|
General disorders
weight gain
|
16.7%
1/6 • 10 weeks
Assessed with staff-administered questionnaire at all in-person and telephone visits following enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place