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

NCT00792298 | Completed Phase 2 Results

• 2 other identifiers: 4305-0062008_583
• Study Type: interventional
• Target: 254
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• LS Mean Sleep Efficiency (SE) During Periods 1 and 2

  SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography \[PSG\] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100

  Night 1 and end of Week 4

Secondary Outcomes (2)

• LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2

  Night 1 and end of Week 4

• LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2

  Night 1 and end of Week 4

Study Arms (8)

Suvorexant 10 mg → Placebo

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Placebo → Suvorexant 10 mg

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Suvorexant 20 mg → Placebo

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Placebo → Suvorexant 20 mg

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Suvorexant 40 mg → Placebo

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Placebo → Suvorexant 40 mg

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Suvorexant 80 mg → Placebo

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Placebo → Suvorexant 80 mg

EXPERIMENTAL

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.

Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

Interventions

Suvorexant DRUG

oral tablet taken before bedtime

Also known as: MK-4305

Placebo → Suvorexant 10 mg; Placebo → Suvorexant 20 mg; Placebo → Suvorexant 40 mg; Placebo → Suvorexant 80 mg; Suvorexant 10 mg → Placebo; Suvorexant 20 mg → Placebo; Suvorexant 40 mg → Placebo; Suvorexant 80 mg → Placebo

Dose-matched Placebo to Suvorexant DRUG

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

Placebo → Suvorexant 10 mg; Placebo → Suvorexant 20 mg; Placebo → Suvorexant 40 mg; Placebo → Suvorexant 80 mg; Suvorexant 10 mg → Placebo; Suvorexant 20 mg → Placebo; Suvorexant 40 mg → Placebo; Suvorexant 80 mg → Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 23197752 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 17, 2008
• Study Start: November 5, 2008
• Primary Completion: December 26, 2009
• Study Completion: December 26, 2009
• Last Updated: November 6, 2018
• Results First Posted: November 14, 2014

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share