A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

(ARISE2 Trial)

Recruiting at 31 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Balance Therapeutics

Must not be taking: Benzodiazepines, Barbiturates, Alcohol

Disqualifiers: Sleep apnea, Obesity, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop taking medications for idiopathic hypersomnia or any other prohibited medications before joining. If you are on stimulants, you must keep your regimen stable throughout the trial.

What is the purpose of this trial?

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.

Research Team

Morgan Lam

Principal Investigator

Chief Operating Officer

Eligibility Criteria

Inclusion Criteria

Onset of hypersomnia between age 10 and 30 years of age

An Epworth Sleepiness Scale score of greater than or equal to 11

Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine (if on stimulants, agree to adhere to stable regimen throughout the trial)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BTD-001 or placebo in a crossover design to evaluate efficacy and safety

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BTD-001
• Pentetrazol (PTZ)
• Placebo oral capsule

Participant Groups

Group I: Subject Receives Placebo first Experimental Treatment 2 Interventions

Group II: Subject Receives BTD001 first Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Balance Therapeutics

Lead Sponsor

Trials

4

Recruited

220+