A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)

NCT ID: NCT01021813

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 781 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-10
• Study Completion Date: 2011-08-01

Brief Summary

This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.

Conditions

Insomnia

Study Design

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

Study Groups

Suvorexant

After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the Treatment Phase.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

Oral tablet (30 mg and 10 mg), administered daily before bedtime

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Oral tablet, administered daily before bedtime

Placebo

After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the Treatment Phase.

Group Type: PLACEBO_COMPARATOR

Dose-matched Placebo to Suvorexant

Intervention Type: DRUG

Oral tablet, administered daily before bedtime

Interventions

Suvorexant

Oral tablet (30 mg and 10 mg), administered daily before bedtime

Intervention Type: DRUG

Dose-matched Placebo to Suvorexant

Oral tablet, administered daily before bedtime

Intervention Type: DRUG

Other Intervention Names

MK-4305

Eligibility Criteria

Inclusion Criteria

• Diagnosis of primary insomnia
• Participant is able to read, understand, and complete questionnaires and diaries
• If female, participant and partner both agree to use acceptable contraception. If male partner does not use an effective form of contraception, female participant must use 2 acceptable forms of contraception
• If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)

Exclusion Criteria

• If female, participant is pregnant
• Participant expects to donate eggs or sperm during the study
• Recent and/or active history of a confounding neurological disorder
• History of clinically unstable cardiovascular disorder within the last 6 months
• Lifetime history of bipolar disorder
• Psychiatric condition that requires treatment with a medication prohibited by the study, or any other psychiatric condition that would interfere with the participant's ability to participate in the study
• History of substance abuse/dependence
• History of cancer ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• Evidence of suicidality (based on a score of 2 on the Quick Inventory of Depressive Symptomatology Self-Report 16-Item ([QIDS-SR16] suicide item #12)
• Participant has travelled across >3 time zones or >3 hour time difference in the last 2 weeks
• History of permanent night shift work or rotating day/night shift work in the past 2 weeks
• Body Mass Index (BMI) >40 kg/m^2

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8.

Reference Type: DERIVED

PMID: 28427826 (View on PubMed)

Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data. Psychopharmacology (Berl). 2017 Jun;234(11):1703-1711. doi: 10.1007/s00213-017-4573-1. Epub 2017 Mar 7.

Reference Type: DERIVED

PMID: 28265715 (View on PubMed)

Michelson D, Snyder E, Paradis E, Chengan-Liu M, Snavely DB, Hutzelmann J, Walsh JK, Krystal AD, Benca RM, Cohn M, Lines C, Roth T, Herring WJ. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 May;13(5):461-71. doi: 10.1016/S1474-4422(14)70053-5. Epub 2014 Mar 27.

Reference Type: DERIVED

PMID: 24680372 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2009_696

Identifier Type: OTHER

Identifier Source: secondary_id

4305-009

Identifier Type: -

Identifier Source: org_study_id