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A Study of Oral BTD-001 in Adults With 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.

Summary

This trial is testing a new oral medication called BTD-001 in adults who have Idiopathic Hypersomnia, a condition causing excessive daytime sleepiness. The study aims to see if BTD-001 can help these individuals stay awake and improve their daily lives. Researchers will also check if the medication is safe and well-tolerated.

Eligible Conditions
  • Excessive Daytime Sleepiness
  • Idiopathic Hypersomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Secondary study objectives
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.

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
Morgan LamStudy DirectorChief Operating Officer
3 Previous Clinical Trials
665 Total Patients Enrolled
~11 spots leftby Dec 2025
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