A Pilot Study of Suvorexant for Insomnia in Parkinson Disease

NCT02729714 | Completed Phase 4 Results

• 1 other identifier: DJB-2015-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if the study drug, suvorexant, is safe and effective in treating symptoms of insomnia in people with Parkinson's Disease. It is anticipated that a total of 20 subjects, 30 to 80 years of age, with Parkinson's Disease and symptoms of insomnia will participate in the study at this site

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Efficiency as Measured by Polysomnogram

  Sleep efficiency is defined as total sleep time divided by total time in bed, expressed as a percent. Polysomnograms were performed at baseline, end of treatment period 1, and end of treatment period 2. A positive change indicates improvement in sleep efficiency. Assessing difference between change in sleep efficiency during suvorexant period and change in sleep efficiency during placebo period.

  4 weeks

Secondary Outcomes (6)

• Wakefulness After Sleep Onset (WASO)

  4 weeks

• Latency to Persistent Sleep (LPS)

  4 weeks

• Insomnia Severity Index (ISI)

  4 weeks

• Epworth Sleepiness Scale (ESS)

  4 weeks

• Subject's Global Impression of Change (SGI-C)

  4 weeks

Study Arms (2)

Suvorexant or Placebo

ACTIVE COMPARATOR

10 Suvorexant or Placebo mg orally at bedtime with an optional up-titration to 15 mg Suvorexant or Placebo orally at bedtime after 2 weeks. The first treatment period will be 4 weeks. Subjects will be randomized 1;1 to receive Suvorexant or matching placebo. Followed by a 2 week washout period with placebo. Subjects will then be crossed over into the alternate treatment group. Subjects on active treatment for period 1 will be switched to placebo, those on placebo in period 1 will switch to Suvorexant

Drug: Suvorexant; Drug: Placebo

Placebo or Suvorexant

PLACEBO COMPARATOR

First treatment period will be 4 week which subjects will be randomized 1;1 with either Suvorexant or placebo. Followed by 2 week washout period with placebo. Subjects will then be crossed over into the alternate treatment group. Subjects on active treatment for period 1 will be switched to placebo, those on placebo in period 1 will switch to Suvorexant.

Drug: Suvorexant; Drug: Placebo

Interventions

Suvorexant DRUG

10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.

Also known as: Belsomra

Placebo or Suvorexant; Suvorexant or Placebo

Placebo DRUG

10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.

Also known as: Sugar Pill

Placebo or Suvorexant; Suvorexant or Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has signed and dated an Institutional Review Board-approved informed consent form before any protocol-specific screening procedures are performed;
• Has a diagnosis of Parkinson disease according to the United Kingdom Parkinson Disease Society Brain Bank Criteria;
• Has a modified Hoehn and Yahr Stage of 1-3, inclusive;
• Is aged 30-80 years old, inclusive;
• Has had no change in Parkinson's Disease medications during the 4 weeks preceding screening, with no dose changes during the study, except that as needed doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms;
• Is willing and able to complete polysomnogram;
• Is subject willing and able to limit alcohol use to 1 alcoholic drink per day during the study period and abstain from alcohol for 6 hours prior to each study-related polysomnogram?
• Is subject willing and able to abstain from caffeine and marijuana for 6 hours prior to and during each study-related polysomnogram
• Is subject willing and able to abstain from products containing nicotine during each study-related polysomnogram?
• Has Insomnia Disorder defined by diagnostic criteria published in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition; namely, subject report of all of the following:
• One of the following: difficulty initiating sleep; difficulty maintaining sleep; or early morning waking;
• Sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning;
• Sleep difficulty has occurred on 3 or more nights per week;
• Sleep difficulty has been present for at least the past 3 months;
• Sleep difficulty occurs despite adequate opportunity for sleep;

You may not qualify if:

• Is a woman who is breast-feeding, pregnant, or has the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures);
• Does subject have an implanted deep brain stimulator?
• Has a history of narcolepsy;
• Has a diagnosis of severe chronic obstructive pulmonary disease, defined by forced expiratory volume in 1 second \< 50% of predicted on most recent available pulmonary function test (a pulmonary function test is not required if the subject has never been diagnosed with chronic obstructive pulmonary disease);
• Has a history of severe obstructive sleep apnea or evidence of severe obstructive sleep apnea on screening polysomnogram, with severe obstructive sleep apnea defined as having an apnea-hypopnea index \> 30;
• Is concurrently using other central nervous system depressants, including alcohol, except that one alcoholic drink per day will be allowed for those with normal hepatic function provided the drink is consumed at least 2 hours prior to or 8 hours after taking the study drug, and no alcohol will be permitted for 24 hours before polysomnogram visits;
• Is concurrently using digoxin;
• Is concurrently using any moderate or strong inhibitor of cytochrome P450 3A;
• Is concurrently using any strong inducer of cytochrome P450 3A;
• Has evidence at screening of severe hepatic impairment as defined by a Child-Pugh score \> 10;
• Has evidence at screening of severe cognitive impairment as defined by a Montreal Cognitive Assessment score \< 15, or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
• Has evidence at screening of suicidal ideation in the past 6 months as defined by a positive response to any one of Questions 2-5 on the Columbia Suicide Severity Rating Scale or of a lifetime history of suicidal behavior as defined by any positive response to the suicidal behavior section of the Columbia Suicide Severity Rating Scale.

Sponsors & Collaborators

• Burdick, Daniel, M.D.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Evergreenhealth Booth Gardner Parkinsons Care Center

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

Designed as a pilot study, so recruitment goal was low and consequently the sample size is small, limiting interpretation of the significance of the differences between suvorexant and placebo.

Results Point of Contact

• Title: Dr. Daniel Burdick
• Organization: EvergreenHealth Medical Center

djburdick@evergreenhealthcare.org

4258993108

Study Officials

• Daniel Burdick, MD

  Booth Gardner Parkinson's Care Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Locations

US (1)