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A Pilot Study of Suvorexant for Insomnia in Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729714
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Daniel Burdick, MD, Burdick, Daniel, M.D.

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

Condition or disease Intervention/treatment Phase
Insomnia Drug: Suvorexant Drug: Placebo Phase 4

Detailed Description:
The proposed study is a randomized, double-blind, placebo-controlled, cross-over trial to assess the safety, tolerability, and efficacy of suvorexant specifically in a cohort of 20 Parkinson's Disease patients between the ages of 30 and 80 (inclusive) who have a complaint of insomnia. After informed consent is given, potential subjects will be screened to ensure they meet eligibility criteria. This will include an overnight polysomnogram, which will serve both as a baseline and a screening polysomnogram. Active drug will be suvorexant 10 mg orally at bed time with an optional up-titration to 15 mg orally at bedtime after 2 weeks. The first treatment period will be 4 weeks long, in which subjects will be randomized 1:1 to receive active drug or matching placebo. At the end of treatment period 1, subjects will undergo efficacy assessment with repeat polysomnogram and clinical scales. This will be followed by a 2-week washout period with placebo; this period only will be single-blinded, as subjects only will be blinded to treatment. Subjects will then be crossed over into the alternate treatment group, which will once again be double-blinded; those on active treatment for period 1 will be switched to placebo, and those on placebo in period 1 will be switched to active treatment. Treatment period 2 will also be 4 weeks long, and at the end of this, subjects will undergo final assessment with polysomnogram and clinical scales.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease
Study Start Date : April 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Suvorexant

Arm Intervention/treatment
Active Comparator: Suvorexant or Placebo
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
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.
Other Name: Belsomra

Drug: Placebo
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.
Other Name: Sugar Pill

Placebo Comparator: Placebo or Suvorexant
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
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.
Other Name: Belsomra

Drug: Placebo
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.
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Sleep Efficiency as measured by Polysomnogram [ Time Frame: week 0, week 5, week 11 ]
    Polysomnogram defined as total sleep time/ total time in bed. Polysomnogram taken in week 0 (baseline), week 5 and week 11. Assessing change in Polysomnograms at week 5 and at week 11


Secondary Outcome Measures :
  1. Wake after sleep onset- WASO [ Time Frame: week 3, week 9, week 15 ]
    Wake after sleep onset is defined as total time spent awake after first epoch of sleep and before final awakening

  2. Latency to Persistent Sleep- LPS [ Time Frame: week , week 9, week 15 ]
    Latency to Persistent sleep is defined as total time between lights out and first epoch of sleep.

  3. Muscle Tonicity [ Time Frame: week 3, week 9, week, 15 ]
    Muscle activity during REM sleep will be recorded as a measure of REM behavior disorder

  4. Insomnia Severity Index- ISI [ Time Frame: week 5, week 9, week, 11, week 15 ]
    The ISI is a 7-question survey assessing symptoms of insomnia. Maximum score is 28, with higher scores indicating greater severity. The ISI has been validated for use in insomnia research (Bastien 2001). This will be performed at Office Visits 2, 3, 4, and 5, and will be a secondary outcome measure.

  5. Epworth Sleepiness Scale-ESS [ Time Frame: week 5, week 9, week, 11, week 15 ]
    The ESS is an 8-question survey assessing symptoms of sleepiness. Maximum score is 24, with higher scores indicating greater severity. The ESS has been validated for use in the general population (Johns 1991) and in PD (Hagell 2007). This will be performed at Office Visits 2, 3, 4, and 5, and will be a secondary outcome measure.

  6. Subject's Global Impression of Change- SGI [ Time Frame: week 7, week 9, week, 11, week 13, week 15 ]
    The SGIC will be assessed by asking a single question "Since baseline (when first starting this study), how have your sleep symptoms changed?" Answers will be on a 7-point scale: 1 = much improved; 2 = somewhat improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = somewhat worse; and 7 = much worse.

  7. Clinicians's Global Impression of Change- CGIC [ Time Frame: week 9, week 11, week 15 ]
    The CGIC will be assessed by the investigator at week9, week 11, week 15 using a similar question: "Since baseline (when first starting this study), how have the subject's sleep symptoms changed?" Answers will be on a 7-point scale: 1 = much improved; 2 = somewhat improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = somewhat worse; and 7 = much



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
    • Insomnia is not explained by another sleep disorder;
    • Insomnia is not attributable to physiological effects of a consumed substance;
  • On screening polysomnogram, has a latency to persistent sleep > 20 minutes OR total wakefulness after sleep onset > 45 minutes;
  • May use other medications that could influence sleep, other than those specifically prohibited, as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study; and
  • Has valid health insurance coverage at the time of study enrollment and expects this coverage to remain valid for the duration of the study period.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729714


Contacts
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Contact: Gowri Rajendran 425-899-5370 grajendran@evergreenhealth.com

Locations
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United States, Washington
Evergreenhealth Booth Gardner Parkinsons Care Center Recruiting
Kirkland, Washington, United States, 98034
Contact: Carey L Gonzales, Coordinator    425-899-5374    clgonzales@evergreenhealth.com   
Contact: Shalom E Kilcup, Coordinator    425-899-5369    sekilcup@evergreenhealth.com   
Principal Investigator: Daniel J Burdick, MD         
Principal Investigator: Pinky Agarwal, MD         
Sponsors and Collaborators
Burdick, Daniel, M.D.
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Daniel Burdick, MD Booth Gardner Parkinson's Care Center

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Responsible Party: Daniel Burdick, MD, Principle Investigator, Burdick, Daniel, M.D.
ClinicalTrials.gov Identifier: NCT02729714    
Other Study ID Numbers: DJB-2015-01
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Parkinson Disease
Sleep Initiation and Maintenance Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action