Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03110315
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2017-03-28
Brief Title:
A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia
Sponsor:
Theodore R Brown MD MPH
Organization:
EvergreenHealth
Study Overview
Official Title:
A Double-blind Crossover Placebo-controlled Study to Compare the Effects of Nighttime Administration of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREAM
Brief Summary:
This study assesses the safety tolerability and efficacy of suvorexant in multiple sclerosis patients Enrolled subjects will receive 2 weeks of treatment during treatment period 1 with either suvorexant or matching placebo 11 After treatment period 1 subjects will undergo a washout period of 1 week then 2 weeks of the alternate treatment either suvorexant or placebo The primary hypothesis is that suvorexant will provide greater improvement in sleep as measured by symptom rating scales compared to placebo
Detailed Description:
The target enrollment number is 30 people with multiple sclerosis who meet inclusion criteria After informed consent is given potential subjects will be screened to ensure they meet eligibility criteria Subjects who meet eligibility criteria will complete baseline assessments and will then be randomized to receive 2 weeks of treatment Treatment Period 1 with either suvorexant or matching placebo 11 The initial dose of suvorexant will be 10 mg at bedtime with optional titration to 20 mg after 5-7 days Study drug will be dispensed by an independent research pharmacist keeping both study staff and the subject blinded All subjects whether in placebo or active arm will receive a wearable sleep monitor to be worn for 7 days at baseline and during both treatment periods All subjects will keep 7-day sleep diaries at baseline and during each study period At the end of Treatment Period 1 2 weeks subjects will undergo efficacy assessments with repeated clinical scales Subjects will then go through a 1-week open-label off-drug washout period Subjects will then be crossed over into the alternate treatment group which will once again be double-blinded those on active treatment suvorexant in Treatment Period 1 will be switched to placebo and those on placebo in Treatment Period 1 will be switched to active treatment Treatment Period 2 will also be 2 weeks long and at the end of this subjects will undergo final assessment with clinical scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None