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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 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
Texas
What site did they apply to?
PAB Clinical Research
Northshore Sleep Medicine
Fort Wayne Neurology
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have seen dozens of specialists,.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
2018. "A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03542851.
All > Idiopathic Hypersomnia
~12 spots leftby Apr 2025
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