Trial Outcomes & Findings for Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia (NCT NCT02153788)

Results Overview

Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

Randomization to final study visit, approximately 12 weeks

Results posted on

2015-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Temazepam After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Overall Study STARTED	25	19
Overall Study COMPLETED	23	18
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Temazepam After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Overall Study Physician Decision	2	1

Baseline Characteristics

Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temazepam n=25 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo n=19 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo	Total n=44 Participants Total of all reporting groups
Age, Customized 21 - 69 years old	25 participants n=5 Participants	19 participants n=7 Participants	44 participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized African American	21 participants n=5 Participants	14 participants n=7 Participants	35 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	19 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to final study visit, approximately 12 weeks

Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.

Outcome measures

Outcome measures
Measure	Temazepam n=23 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo n=18 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Mean Change in the Insomnia Severity Index	-4.01 units on a scale Standard Deviation 5.3	0.72 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Randomization to final study visit, approximately 12 weeks

Population: Data not collected, and therefore not analyzed.

Mean change in self reported Total Sleep Time from Randomization to Final Study Visit in the placebo-controlled phase.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization to the end of the open label phase, approximately 1 week

Population: Data not collected, and therefore not analyzed.

Mean change in self-reported total sleep time from randomization to the end of the open label phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 12

A multidimensional scale for measuring fatigue, whose validity and reliability have been established across many patient populations including cancer patients, HIV, pregnancy, and myocardial infarction. There are 22 questions, in 3 subscales that measure behavioral, affective meaning, sensory and cognitive/mood aspects of fatigue, each scored on an 11-point likhert scale with a score of 0-10, 0 indicating no fatigue and 10 indicating the most severe fatigue. The Piper Fatigue Scale can range from 0 to 220 with higher scores indicating greater fatigue.

Outcome measures

Outcome measures
Measure	Temazepam n=23 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo n=18 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Mean Change in Piper Fatigue Score Baseline	108 units on a scale Standard Deviation 48	126 units on a scale Standard Deviation 42
Mean Change in Piper Fatigue Score Week 12	57.9 units on a scale Standard Deviation 41	113 units on a scale Standard Deviation 46

SECONDARY outcome

Timeframe: Baseline, week 12

A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.

Outcome measures

Outcome measures
Measure	Temazepam n=23 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo n=18 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Baseline	7.1 units on a scale Standard Deviation 4.1	8.6 units on a scale Standard Deviation 4.0
Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Week 12	7.3 units on a scale Standard Deviation 5.3	7.1 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: Baseline, week 12

A clinical tool that has been validated widely especially in cancer patients, to detect clinically significant emotional distress. This is a one-item scale that asks participants to rate their distress on scale from 0-100. Lower scores represent less distress and higher scores indicate greater distress.

Outcome measures

Outcome measures
Measure	Temazepam n=23 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo n=18 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Mean Change in the Distress Thermometer Baseline	44 units on a scale Standard Deviation 24.4	49.9 units on a scale Standard Deviation 25.3
Mean Change in the Distress Thermometer Week 12	43 units on a scale Standard Deviation 26	39 units on a scale Standard Deviation 27

SECONDARY outcome

Timeframe: Baseline, week 12

A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.

Outcome measures

Outcome measures
Measure	Temazepam n=23 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo n=18 Participants After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D) Baseline	8.1 units on a scale Standard Deviation 4.2	8.1 units on a scale Standard Deviation 4.0
Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D) Week 12	7.3 units on a scale Standard Deviation 5.3	7.1 units on a scale Standard Deviation 5.2

Adverse Events

Temazepam

Serious events: 0 serious events

Other events: 4 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

Other adverse events
Measure	Temazepam n=23 participants at risk After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Temazepam: Temazepam 15 mg orally at bedtime	Placebo n=18 participants at risk After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Placebo
Gastrointestinal disorders dry mouth	13.0% 3/23	5.6% 1/18
Nervous system disorders lethargy	4.3% 1/23	5.6% 1/18

Additional Information

Andrew Krystal, MD

Duke University Medical Center

Phone: 919-681-8742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place