Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia

NCT00755508 | Completed Phase 2

• 2 other identifiers: 01-05-TL-375-055U1111-1114-3348
• Study Type: interventional
• Target: 378
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the efficacy and safety of ramelteon, once daily (QD), taken in combination with Gabapentin for treating insomnia.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean objective wake time after persistent sleep onset in sleep lab.

  Nights: 1 and 2.

Secondary Outcomes (6)

• Subjective wake time after persistent sleep onset determined by the post-sleep questionnaire.

  Nights: 1, 2, 3, 4, 5, 6 and 7.

• Number of awakenings after persistent sleep polysomnography.

  Nights: 1 and 2

• Subjective number of awakenings as determined by post-sleep questionnaire.

  Nights: 1, 2, 3, 4, 5, 6 and 7.

• Latency to persistent sleep and total sleep time as determined by polysomnography.

  Nights: 1 and 2

• Subjective sleep latency, subjective total sleep time and subjective sleep quality determined by post-sleep questionnaire.

  Nights: 1, 2, 3, 4, 5, 6 and 7.

Study Arms (5)

Ramelteon 4 mg QD and Gabapentin 400 mg QD

EXPERIMENTAL

Drug: Ramelteon and gabapentin

Ramelteon 8 mg QD and Gabapentin 800 mg QD

EXPERIMENTAL

Drug: Ramelteon and gabapentin

Ramelteon 8 mg QD and Gabapentin Placebo QD

EXPERIMENTAL

Drug: Ramelteon

Gabapentin 800 mg QD

ACTIVE COMPARATOR

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon and gabapentin DRUG

Ramelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week.

Also known as: TAK-375, Ramelteon, Neurontin®, Rozerem

Ramelteon 4 mg QD and Gabapentin 400 mg QD

Ramelteon DRUG

Ramelteon 8 mg, tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.

Also known as: TAK-375, Rozerem

Ramelteon 8 mg QD and Gabapentin Placebo QD

Gabapentin DRUG

Ramelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.

Also known as: Neurontin®, Rozerem

Gabapentin 800 mg QD

Placebo DRUG

Ramelteon placebo-matching tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.

Also known as: Rozerem

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients of childbearing potential must be nonpregnant and nonlactating, and utilizing an acceptable method of contraception.
• Based on sleep history, the subject has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised (DSM-IV-TR™) for at least 3 months.
• Based on sleep history, reports a subjective sleep latency greater than or equal to 45 minutes and reports wake time after persistent sleep onset of greater than or equal to 45 minutes.
• Has an average wake time after persistent sleep onset of at least 60 minutes as determined by polysomnography during Screening (Day minus 7 PM through Day minus 5 AM). Wake time after persistent sleep onset must be greater than or equal to 30 minutes each night of polysomnography Screening.
• Reports wake time after persistent sleep onset values of at least 60 minutes on at least 3 of the 7 nights during the single-blind screening period (Day minus 6 AM through Day 1 AM) as determined by post-sleep questionnaire.
• Has an average latency to persistent sleep of at least 20 minutes as determined by polysomnography during Screening (Day minus 7 PM through Day minus 5 AM).
• Based on sleep history, has an habitual bedtime between 9:00 PM and 1:00 AM.
• The subject is willing to have a fixed bedtime and agrees to go to bed within plus or minus 30 minutes of the habitual bedtime during the entire study and agrees to remain in bed for at least 8 hours each night.
• Based on sleep history, has not been using pharmacological assistance to sleep or uses pharmacological assistance no more than 4 times per week during the 3 months prior to Initial Screening.
• Has consistent access to a touch-tone phone and are willing to complete telephone questionnaires twice daily during participation in the study.

You may not qualify if:

• Has a known hypersensitivity to gabapentin or its ingredients, ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan.
• Has participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of single-blind study medication.
• Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first dose of single-blind study medication.
• Has flown across greater than 3 time zones within 7 days prior to Initial Screening, or will travel across 2 or more time zones during the course of the study.
• Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first dose of single-blind study medication.
• Has ever had a history of seizures, sleep apnea, and/or chronic obstructive pulmonary disease.
• Has a history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months of Initial Screening.
• Has a history of fibromyalgia.
• Has a history of drug addiction or drug abuse within the past 12 months of Initial Screening.
• Has a history of alcohol abuse within the past 12 months, as defined in DSM-IV-TR™ and/or regularly consumes more than 2 alcoholic drinks per day.
• Has a current significant hepatic, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, metabolic or neurological disorders, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first dose of single-blind study medication.
• Has any diagnosed renal impairment within 30 days prior to the first dose of single-blind study medication.
• Has a previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of single-blind study drug.
• Uses tobacco products or any other products that may interfere with the sleep wake cycle during nightly awakenings.
• 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:

Sponsors & Collaborators

• Takeda: lead

Related Links

• Rozerem Package Insert.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic

Interventions

ramelteon; Gabapentin

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sr. VP Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: November 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 28, 2012

Record last verified: 2012-02