A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
Public ClinicalTrials.gov record NCT02512588. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Placebo-Controlled, Double-blind, Fixed-Dose, Multiple Cohort, Multiple Crossover, Dose-Finding Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
Study identification
- NCT ID
- NCT02512588
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Balance Therapeutics
- Industry
- Enrollment
- 120 participants
Conditions and interventions
Interventions
- BTD-001 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2015
- Primary completion
- Jan 31, 2018
- Completion
- Jan 31, 2018
- Last update posted
- Jan 15, 2019
2015 – 2018
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | — |
| Stanford Medicine Sleep Center | Palo Alto | California | 94304 | — |
| Pacific Research Network | San Diego | California | 92103 | — |
| Empire Clinical Research | Upland | California | 91786 | — |
| REM Sleep Medicine, Colorado Sleep Institute | Boulder | Colorado | 80301 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Clinical Research Group of St. Petersburg | St. Petersburg | Florida | 33707 | — |
| Emory University School of Medicine Emory Sleep Center | Atlanta | Georgia | 30329 | — |
| NeuroTrials Research Inc | Atlanta | Georgia | 30342 | — |
| SleepMed of Central | Macon | Georgia | 31201 | — |
| Kentucky Research Group, | Louisville | Kentucky | 40218 | — |
| The Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| NeuroCare Center for Sleep | Newton | Massachusetts | 02459 | — |
| Neurological Associate | Maplewood | Minnesota | 55109 | — |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Community Research Management Assoc. | Cincinnati | Ohio | 45255 | — |
| Lynn Institute | Oklahoma City | Oklahoma | 73112 | — |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | — |
| Future Search Trials of Neurology | Austin | Texas | 78731 | — |
| Houston Sleep Center | Houston | Texas | 77063 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02512588, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 15, 2019 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02512588 live on ClinicalTrials.gov.