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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR TEMAZEPAM

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Clinical Trials for Temazepam

Trial ID Title Status Sponsor Phase Summary
NCT00245661 Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease Completed Rijnstate Hospital Phase 3 The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease. The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.
NCT00330291 Xyrem for Treatment Refractory Insomnia Due to PTSD Withdrawn State University of New York - Upstate Medical University Phase 2 Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur. Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD. The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population.
NCT00465972 The Treatment of Insomnia in Patients With HIV Disease Completed Duke University Phase 4 This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.
NCT00940550 Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women Completed H. Lundbeck A/S Phase 1 This study has been designed to compare the effects of melatonin with those of drugs (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy, middle-aged volunteers. The study will take place at one centre. Volunteers consenting to participate in the study will have their eligibility confirmed by a screening panel, including spending one night in the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be collected during this overnight visit. Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam, zolpidem and placebo as a single dose during 4 treatment phases lasting one night and separated by at least five days. Neither the volunteer nor the study staff will be aware of which drug each volunteer is receiving at each treatment phase. The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of sleep, including measures of sleep quality, will also be measured. Urine samples will be collected during each treatment phase. Volunteers will undergo an assessment of health prior to departure from the clinic at their last treatment phase, and study staff will telephone 2 weeks later to obtain further information on their health status. The primary study objective is to compare EEG power spectra during nonREM sleep in the slow-wave frequencies following administration with melatonin to temazepam.
NCT00940550 Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women Completed University of Surrey Phase 1 This study has been designed to compare the effects of melatonin with those of drugs (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy, middle-aged volunteers. The study will take place at one centre. Volunteers consenting to participate in the study will have their eligibility confirmed by a screening panel, including spending one night in the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be collected during this overnight visit. Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam, zolpidem and placebo as a single dose during 4 treatment phases lasting one night and separated by at least five days. Neither the volunteer nor the study staff will be aware of which drug each volunteer is receiving at each treatment phase. The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of sleep, including measures of sleep quality, will also be measured. Urine samples will be collected during each treatment phase. Volunteers will undergo an assessment of health prior to departure from the clinic at their last treatment phase, and study staff will telephone 2 weeks later to obtain further information on their health status. The primary study objective is to compare EEG power spectra during nonREM sleep in the slow-wave frequencies following administration with melatonin to temazepam.
NCT01519544 Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude Completed Massachusetts General Hospital N/A More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to answer the question: Which medication is associated with better sleep at high altitude: temazepam or acetazolamide? The investigators hypothesis is that one medication will be associated with higher subjective sleep scores than the other. The study will compare the sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit to high altitude.
NCT02153788 Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia Completed Duke University Phase 4 The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and one of which is a placebo (an inactive substance that looks just like the temazepam), to see if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are given in research studies to try and make sure that subjects are responding to the effects of the study drug and not to other factors, like the attention they are receiving. If you decide to take part in this study, you will take 1 capsule of study drug every night approximately 30 minutes before bedtime for approximately 12 weeks. This study is to test the study drug called temazepam for the treatment of insomnia (trouble sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the treatment of insomnia. However, because this study requires treatment for 12 weeks instead of the 7 to 10 days approved by the FDA, the use of temazepam is considered to be investigational in this study.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Temazepam

Condition Name

Condition Name for Temazepam
Intervention Trials
Insomnia 3
Anxiety, Post Traumatic 1
PTSD 1
Intensive Care Psychosis 1
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Condition MeSH

Condition MeSH for Temazepam
Intervention Trials
Sleep Initiation and Maintenance Disorders 2
Pulmonary Disease, Chronic Obstructive 1
Sleep Wake Disorders 1
Lung Diseases, Obstructive 1
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Clinical Trial Locations for Temazepam

Trials by Country

Trials by Country for Temazepam
Location Trials
United States 2
Lebanon 1
Netherlands 1
Nepal 1
United Kingdom 1
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Trials by US State

Trials by US State for Temazepam
Location Trials
North Carolina 1
New York 1
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Clinical Trial Progress for Temazepam

Clinical Trial Phase

Clinical Trial Phase for Temazepam
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Temazepam
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 1
Withdrawn 1
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Clinical Trial Sponsors for Temazepam

Sponsor Name

Sponsor Name for Temazepam
Sponsor Trials
Duke University 2
State University of New York - Upstate Medical University 1
Rijnstate Hospital 1
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Sponsor Type

Sponsor Type for Temazepam
Sponsor Trials
Other 7
Industry 1
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