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Generated: February 23, 2019

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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NCT00330291 Xyrem for Treatment Refractory Insomnia Due to PTSD Withdrawn State University of New York - Upstate Medical University Phase 2 Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep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.
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
High-altitude Sleep Disturbance 1
Chronic Obstructive Pulmonary Disease 1
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Condition MeSH

Condition MeSH for Temazepam
Intervention Trials
Sleep Initiation and Maintenance Disorders 2
Psychotic Disorders 1
Mental Disorders 1
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Clinical Trial Locations for Temazepam

Trials by Country

Trials by Country for Temazepam
Location Trials
United States 2
United Kingdom 1
Lebanon 1
Netherlands 1
Nepal 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
University of Surrey 1
H. Lundbeck A/S 1
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Sponsor Type

Sponsor Type for Temazepam
Sponsor Trials
Other 7
Industry 1
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US Department of Justice
Fish and Richardson
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Daiichi Sankyo

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