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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Primary Insomnia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792298

4305-006

2008_583 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 254 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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254 participants in 8 patient groups

Suvorexant 10 mg → Placebo

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant

Placebo → Suvorexant 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant

Suvorexant 20 mg → Placebo

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant

Placebo → Suvorexant 20 mg

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant

Suvorexant 40 mg → Placebo

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant

Placebo → Suvorexant 40 mg

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant

Suvorexant 80 mg → Placebo

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant

Placebo → Suvorexant 80 mg

Experimental group

Description:

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.

Treatment:

Drug: Dose-matched Placebo to Suvorexant

Drug: Suvorexant