Ramelteon for Insomnia Comorbid With Asthma

NCT00869167 | Terminated Phase 3 Results

• 1 other identifier: 07-052R
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Conditions

Insomnia; Asthma

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index

  The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms

  baseline and post-treatment (at end of 5 weeks)

• Insomnia Severity Index

  The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms

  5 weeks

Secondary Outcomes (3)

• Daytime Sleepiness (Epworth Sleepiness Scale)

  baseline and post-treatment (at end of 5 weeks)

• Daytime Performance (Digit Symbol Substitution Test)

  baseline and post-treatment (at end of 5 weeks)

• Daytime Lung Function (Peak Flow Monitoring) in Liter/Min

  baseline and during treatment period (during 5th week)

Study Arms (2)

1: Ramelteon

EXPERIMENTAL

Drug: Ramelteon

2: Placebo

PLACEBO COMPARATOR

Drug: Ramelteon

Interventions

Ramelteon DRUG

melatonin agonist

Also known as: Rozerem

1: Ramelteon; 2: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 - 60 with both insomnia and asthma.
• Insomnia:
• a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality,
• the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and
• at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months.
• Asthma will be diagnosed based on suggestive clinical history and either
• airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less
• bronchodilator-responsive expiratory airflow limitation (if FEV1 \< 70% of predicted value or \< 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score \< 1.5.

You may not qualify if:

• Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI \> 15), periodic leg movements (movement arousal index \> 15), REM behavior disorder; or circadian sleep-wake disorders
• History of cognitive or other neurological disorders;
• History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;
• Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;
• Unstable or serious medical conditions;
• Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);
• Shift work or other types of self imposed irregular sleep schedules;
• Obesity (BMI \> 35 Kg/m2); or
• Pregnancy or desire to become pregnant during the study.

Sponsors & Collaborators

• Northwestern University: lead
• Takeda: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Asthma

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Recruitment difficulties led to only 3 participants in the study. Only 2 participants finished the study.

Results Point of Contact

• Title: Brandon Lu, M.D., M.S.
• Organization: California Pacific Medical Center

lubs@sutterhealth.org

415-923-3421

Study Officials

• Brandon S Lu, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 1, 2013
• Results First Posted: June 29, 2012

Record last verified: 2013-04

Locations

US (1)