Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

NCT ID: NCT00792298

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-05
• Study Completion Date: 2009-12-26

Brief Summary

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Suvorexant 10 mg → Placebo

After an \~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Placebo → Suvorexant 10 mg

After an \~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Suvorexant 20 mg → Placebo

After an \~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Placebo → Suvorexant 20 mg

After an \~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Suvorexant 40 mg → Placebo

After an \~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Placebo → Suvorexant 40 mg

After an \~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Suvorexant 80 mg → Placebo

After an \~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Placebo → Suvorexant 80 mg

After an \~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

oral tablet taken before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Interventions

Suvorexant

oral tablet taken before bedtime

Intervention Type: DRUG

Dose-matched Placebo to Suvorexant

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Intervention Type: DRUG

Other Intervention Names

MK-4305

Eligibility Criteria

Inclusion Criteria

• Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment
• Must be willing to stay overnight at a sleep laboratory
• Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
• Regular bedtime is between 9 PM and 12 AM (midnight)

Exclusion Criteria

• Breast feeding, pregnant or planning to become pregnant during the study
• Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
• Currently participating or have participated in a study with an investigational compound or device within the last 30 days
• Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study
• Has done shift work within the past 2 weeks
• Has donated blood products within the last 8 weeks
• Has difficulty sleeping due to a medical condition

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.

Reference Type: RESULT

PMID: 23197752 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2008_583

Identifier Type: OTHER

Identifier Source: secondary_id

4305-006

Identifier Type: -

Identifier Source: org_study_id