Trial Outcomes & Findings for Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD) (NCT NCT00393874)
NCT ID: NCT00393874
Last Updated: 2016-10-24
Results Overview
Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score \< 8 is considered to reflect no significant insomnia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Screening, Post, and Follow-up
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
Medication
Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary.
|
Behavioral
Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction.
|
Placebo
Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
15
|
|
Overall Study
COMPLETED
|
15
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Medication
n=18 Participants
Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary.
|
Behavioral
n=17 Participants
Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction.
|
Placebo
n=15 Participants
Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
|
Total
n=50 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Continuous
|
39.4 years
STANDARD_DEVIATION 11.9 • n=93 Participants
|
40.0 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
43.6 years
STANDARD_DEVIATION 14.0 • n=27 Participants
|
41.0 years
STANDARD_DEVIATION 13.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
17 participants
n=4 Participants
|
15 participants
n=27 Participants
|
50 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Screening, Post, and Follow-upPopulation: For the medication arm, 18 participants completed ISI at screening, 15 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.
Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score \< 8 is considered to reflect no significant insomnia.
Outcome measures
| Measure |
Medication
n=18 Participants
Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary.
|
Behavioral
n=17 Participants
Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction.
|
Placebo
n=15 Participants
Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
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|---|---|---|---|
|
Insomnia Severity Index
Follow-up
|
7.0 units on a scale
Standard Deviation 4.7
|
5.5 units on a scale
Standard Deviation 5.0
|
8.7 units on a scale
Standard Deviation 5.1
|
|
Insomnia Severity Index
Screening
|
16.4 units on a scale
Standard Deviation 4.4
|
16.5 units on a scale
Standard Deviation 4.0
|
14.8 units on a scale
Standard Deviation 3.7
|
|
Insomnia Severity Index
Post
|
9.3 units on a scale
Standard Deviation 7.2
|
6.8 units on a scale
Standard Deviation 5.0
|
11.8 units on a scale
Standard Deviation 5.0
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PRIMARY outcome
Timeframe: baseline and postPopulation: For the medication arm, 15 participants completed the sleep diary (SD) at baseline and 13 returned a SD post treatment. For the Behavioral arm, 15 participants completed the SD at baseline, and 12 returned it at follow-up. For the placebo arm, 12 participants completed the diary at baseline and 10 returned one at follow-up.
Sleep diary SE, nightmare frequency Sleep diary sleep efficiency can range from 0 to 100%, and typically varies between 50% and 95%. Higher % values reflect greater sleep consolidation, i.e., greater ratio of time asleep/time in bed. Nightmare frequency varies between 0 and no upper limit is provided. Greater frequency of nightmares reflects greater nightmare severity.
Outcome measures
| Measure |
Medication
n=18 Participants
Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary.
|
Behavioral
n=15 Participants
Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction.
|
Placebo
n=13 Participants
Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
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|---|---|---|---|
|
Sleep Diary Measures
SE Post Treatment
|
92.2 units on a scale
Standard Deviation 4.3
|
94.8 units on a scale
Standard Deviation 3.0
|
90.1 units on a scale
Standard Deviation 5.2
|
|
Sleep Diary Measures
NF Pre Treatment
|
1.0 units on a scale
Standard Deviation 1.1
|
.09 units on a scale
Standard Deviation 1.4
|
.4 units on a scale
Standard Deviation 1.1
|
|
Sleep Diary Measures
NF Post Treatment
|
.3 units on a scale
Standard Deviation .8
|
.0 units on a scale
Standard Deviation .0
|
.5 units on a scale
Standard Deviation 1.1
|
|
Sleep Diary Measures
SE Pre Treatment
|
84.5 units on a scale
Standard Deviation 11.8
|
85.5 units on a scale
Standard Deviation 9.8
|
85.8 units on a scale
Standard Deviation 8.0
|
PRIMARY outcome
Timeframe: Baseline sleep study and post sleep studyPopulation: For the medication arm, 18 participants completed a PSG study at baseline and 13 completed a PSG post treatment. For the Behavioral arm, 17 participants completed a PSG at baseline and 12 completed a PSG post-treatment. For the placebo arm, 15 participants completed a PSG at baseline and 12 completed a PSG post-treatment.
Sleep Efficiency (SE) is the ratio of total time spent asleep over total time spent in bed. For PSG studies, (SE) typically vary between 50% and 95%. Greater values indicated more consolidated sleep.
Outcome measures
| Measure |
Medication
n=18 Participants
Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary.
|
Behavioral
n=17 Participants
Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction.
|
Placebo
n=15 Participants
Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
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|---|---|---|---|
|
PSG Composite Measure
Sleep Efficiency : Baseline
|
82.0 percentage of time asleep vs time in bed
Standard Deviation 11.4
|
78.9 percentage of time asleep vs time in bed
Standard Deviation 2.1
|
87.1 percentage of time asleep vs time in bed
Standard Deviation 8.1
|
|
PSG Composite Measure
Sleep Efficiency: Post
|
89.2 percentage of time asleep vs time in bed
Standard Deviation 7.1
|
84.5 percentage of time asleep vs time in bed
Standard Deviation 6.5
|
89.1 percentage of time asleep vs time in bed
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Baseline, post, 4 months post-treatmentPopulation: For the medication arm, 18 participants completed PSQI at screening, 14 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.
Self-report sleep quality measure. Scores range between 0 and 21, with higher scores reflecting poor sleep quality. A score of \< or = to 5 reflects good sleep quality.
Outcome measures
| Measure |
Medication
n=18 Participants
Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary.
|
Behavioral
n=17 Participants
Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction.
|
Placebo
n=15 Participants
Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
|
|---|---|---|---|
|
PSQI
PSQI: Baseline
|
16.4 units on a scale
Standard Deviation 4.4
|
16.5 units on a scale
Standard Deviation 4.0
|
14.8 units on a scale
Standard Deviation 3.7
|
|
PSQI
PSQI: Post
|
7.6 units on a scale
Standard Deviation 2.9
|
5.5 units on a scale
Standard Deviation 3.2
|
8.9 units on a scale
Standard Deviation 3.4
|
|
PSQI
PSQI: 4-month follow up
|
5.9 units on a scale
Standard Deviation 2.2
|
5.5 units on a scale
Standard Deviation 4.1
|
7.5 units on a scale
Standard Deviation 3.4
|
Adverse Events
Medication
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Behavioral
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medication
n=15 participants at risk
Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.
Prazosin: Participants randomized to PRZ took 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin was 10 mg. Some individuals required doses up to 15 mg.
|
Behavioral
n=13 participants at risk
Participants randomized to BSI received the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment was administered over 8 weeks. The intervention sessions consisted of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session was conducted on Week 5. Thirty-minute face-to-face contacts were scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that had occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni
|
Placebo
n=13 participants at risk
Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.
Placebo: Participants randomized to PLA took 4 capsules each night for eight weeks, all capsules were identical to prazosin capsules. They received a one-week medication.
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|---|---|---|---|
|
Nervous system disorders
Headache, drowsiness
|
26.7%
4/15 • Number of events 4 • Adverse events and side effects were monitored throughout the duration of study participation.
Events reported are (expected) side effects that were monitored throughout the duration of study participation. Side effects were assessed using the Asberg Side Effects Scale.
|
23.1%
3/13 • Number of events 3 • Adverse events and side effects were monitored throughout the duration of study participation.
Events reported are (expected) side effects that were monitored throughout the duration of study participation. Side effects were assessed using the Asberg Side Effects Scale.
|
15.4%
2/13 • Adverse events and side effects were monitored throughout the duration of study participation.
Events reported are (expected) side effects that were monitored throughout the duration of study participation. Side effects were assessed using the Asberg Side Effects Scale.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place