Your session is about to expire
← Back to Search
Other
Subject Receives BTD001 first for Idiopathic Hypersomnia (ARISE2 Trial)
Phase 2
Waitlist Available
Research Sponsored by Balance Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline.
Awards & highlights
ARISE2 Trial Summary
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
Eligible Conditions
- Idiopathic Hypersomnia
ARISE2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Secondary outcome measures
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
ARISE2 Trial Design
2Treatment groups
Experimental Treatment
Group I: Subject Receives Placebo firstExperimental Treatment2 Interventions
Group II: Subject Receives BTD001 firstExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral capsule
2010
Completed Phase 4
~2380
Find a Location
Who is running the clinical trial?
Balance TherapeuticsLead Sponsor
3 Previous Clinical Trials
138 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
120 Patients Enrolled for Idiopathic Hypersomnia
Morgan LamStudy DirectorChief Operating Officer
3 Previous Clinical Trials
665 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger