CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Suvorexant 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02729714
NCT02729714Phase 4Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease

Burdick, Daniel, M.D.·interventional·Posted Apr 6, 2016·Updated Aug 20, 2024

In Brief

A Phase 4 clinical trial evaluating Suvorexant and Placebo for Insomnia. Completed, enrolled 21 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 6, 2016
Enrollment StartApr 1, 2016
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 10.2 years ago

Interventions

Suvorexantdrug

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.

Placebodrug

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.