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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00755508 |
The purpose of this study is to determine the efficacy and safety of Rozerem™ taken in combination with Gabapentin for treating insomnia.
Condition | Intervention | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders |
Drug: Rozerem and gabapentin Drug: Rozerem Drug: Gabapentin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Proof-of-Concept Study to Evaluate the Safety and Efficacy of ROZEREM™ Taken in Combination With Gabapentin for the Treatment of Subjects With Chronic Insomnia |
Enrollment: | 378 |
Study Start Date: | November 2005 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Rozerem and gabapentin
Rozerem 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week.
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2: Experimental |
Drug: Rozerem and gabapentin
Rozerem 8 mg, tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.
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3: Experimental |
Drug: Rozerem
Rozerem 8 mg, tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.
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4: Active Comparator |
Drug: Gabapentin
Rozerem placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.
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5: Placebo Comparator |
Drug: Placebo
Rozerem placebo-matching tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.
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Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is also associated with diminished work output, absenteeism, and greater rates of accidents. gamma-aminobutyric acid is the major inhibitory transmitter in the central nervous system and most currently prescribed sleep agents are benzodiazepine receptor agonists, which induce sleep by binding to the benzodiazepine receptor site of the gamma-aminobutyric acid -A receptor complex. In addition to sleep, benzodiazepine receptor agonists can cause a wide range of ancillary effects not directly related to sleep, including sedative, anxiolytic, muscle-relaxant, and amnesic effects, and have risks of tolerance, dependence, and abuse potential.
Gabapentin is a novel anti-epileptic drug, which is currently used in subjects with partial seizures. Some studies have shown that gabapentin also has an effect on sleep architecture. In several studies, which included healthy subjects, epileptic subjects, and subjects with restless leg syndrome, the use of gabapentin been shown to prolong slow-wave sleep, increase total sleep time and sleep efficiency, and decrease number of awakenings.
Rozerem™ is a melatonin receptor agonist with affinity for the human melatonin receptor subtype 1, melatonin receptor subtype 2 and selectivity over the melatonin receptor subtype 3 receptor. It also demonstrates agonist activity in vitro relative to melatonin in cells expressing human melatonin receptor subtype 1 or melatonin receptor subtype 2 receptors. The binding of melatonin at these receptors is thought to contribute to maintenance of the circadian rhythm underlying the normal sleep-wake cycle.
The purpose of this trial is to determine if the co-administration of Rozerem™ and gabapentin may produce increased sleep efficiency through reduction of wake time after persistent sleep onset, in addition to the reduction in sleep latency and increase in sleep duration. Study participation is anticipated to be about one month.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Is required to take or intends to continue taking any disallowed medication or any prescription medication or over-the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication, including:
Has any additional condition(s) that in the Investigator's opinion would:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | 01-05-TL-375-055 |
Study First Received: | September 17, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00755508 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic Insomnia DIMS (Disorders of Initiating and Maintaining Sleep) Disorders of Initiating and Maintaining Sleep Insomnia Disorder Sleep Initiation Dysfunction |
Transient Insomnia Drug Therapy Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Gabapentin Psychotropic Drugs Central Nervous System Depressants Sleep Disorders Dyssomnias Calcium Channel Blockers |
Cardiovascular Agents Antimanic Agents Sleep Disorders, Intrinsic Calcium, Dietary Mental Disorders Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Sleep Disorders Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Sleep Disorders, Intrinsic Membrane Transport Modulators Sensory System Agents Mental Disorders |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Nervous System Diseases Dyssomnias Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |