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Sponsored by: |
Neurogen Corporation |
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Information provided by: | Neurogen Corporation |
ClinicalTrials.gov Identifier: | NCT00683436 |
This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm crossover study in patients with primary insomnia.
Condition | Intervention | Phase |
---|---|---|
Primary Insomnia |
Drug: Adipiplon Drug: Placebo Drug: Ambien CR |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Blinded, Active and Placebo-Controlled, Crossover Study of the Efficacy and Safety of Two Doses of Adipiplon Bilayer Tablets in Primary Insomniacs |
Estimated Enrollment: | 84 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
adipiplon 6 mg
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Drug: Adipiplon
bilayer tablets 6 mg
|
2: Experimental
adipiplon 9 mg
|
Drug: Adipiplon
bilayer tablets 9 mg
|
3: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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4: Experimental
Ambien CR 12.5 mg
|
Drug: Ambien CR
Ambien CR 12.5 mg
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Prospective patients will spend 2 nights in the sleep lab for baseline PSG assessments. Those who meet the protocol inclusion/exclusion criteria will return for four treatment periods with two consecutive nights in each.
Study medication will be administered in the sleep laboratory 30 minutes before the patient's usual bedtime.
Ages Eligible for Study: | 21 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Miami Research Associates | |
South Miami, Florida, United States, 33143 | |
Broward Research Group | |
Pembroke Pines, Florida, United States, 33026 | |
United States, Georgia | |
Neurotrials Research, Inc | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
Sleep and Behavior Medicine Institute | |
Vernon Hills, Illinois, United States, 60061 | |
United States, Kansas | |
Vince & Associates Clinical Research | |
Overland Park, Kansas, United States, 66212 | |
United States, Missouri | |
St. Luke's Hospital Sleep Medicine and Research Center | |
Chesterfield, Missouri, United States, 63017 | |
United States, New York | |
Clinilabs, Inc. | |
New York, New York, United States, 10019 | |
United States, Ohio | |
Tri-State Sleep Disorders Center | |
Cincinnati, Ohio, United States, 45246 | |
United States, Oklahoma | |
Lynn Health Science Institute | |
Oklahoma City, Oklahoma, United States, 73112 |
Responsible Party: | Neurogen Corporation ( Study Manager ) |
Study ID Numbers: | NG2-73-205 |
Study First Received: | May 21, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00683436 History of Changes |
Health Authority: | United States: Food and Drug Administration |
insomnia |
Zolpidem Sleep Initiation and Maintenance Disorders Mental Disorders |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |