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This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTD-001 | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTD-001 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Epworth Sleepiness Scale | Epworth Sleepiness Scale | After 14 days per treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Maintenance of Wakefulness Test | Maintenance of Wakefulness Test | After 14 days per treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax) | Pharmacokinetic parameters after multiple doses. -Maximum serum concentration (Cmax) | Selected Days 14, 35, and 56 |
| Pharmacokinetics (Tmax) | Pharmacokinetic parameters after multiple doses. -Time of maximum plasma concentration (Tmax) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Lien, PhD | Balance Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Stanford Medicine Sleep Center |
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|
| Selected Days 14, 35, and 56 |
| Pharmacokinetics (T½) | Pharmacokinetic parameters after multiple doses. -Elimination half life (T½) | Selected Days 1, 14, 31, 35, 42, and 56 |
| Pharmacokinetics (AUC) | Pharmacokinetic parameters after multiple doses. -Area under the concentration time curve (AUC) | Selected Days 1, 14, 21, 35, 42, and 56 |
| Palo Alto |
| California |
| 94304 |
| United States |
| Pacific Research Network | San Diego | California | 92103 | United States |
| Empire Clinical Research | Upland | California | 91786 | United States |
| REM Sleep Medicine, Colorado Sleep Institute | Boulder | Colorado | 80301 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Clinical Research Group of St. Petersburg | St. Petersburg | Florida | 33707 | United States |
| Emory University School of Medicine Emory Sleep Center | Atlanta | Georgia | 30329 | United States |
| NeuroTrials Research Inc | Atlanta | Georgia | 30342 | United States |
| SleepMed of Central | Macon | Georgia | 31201 | United States |
| Kentucky Research Group, | Louisville | Kentucky | 40218 | United States |
| The Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| NeuroCare Center for Sleep | Newton | Massachusetts | 02459 | United States |
| Neurological Associate | Maplewood | Minnesota | 55109 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Community Research Management Assoc. | Cincinnati | Ohio | 45255 | United States |
| Lynn Institute | Oklahoma City | Oklahoma | 73112 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Future Search Trials of Neurology | Austin | Texas | 78731 | United States |
| Houston Sleep Center | Houston | Texas | 77063 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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