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This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NLS-2 (mazindol extended release) | Active Comparator | 2 mg dosed orally, once daily for 1 week; followed by 3 mg dosed orally, once daily for up to 3 weeks (total of 4 weeks) |
|
| Placebo | Placebo Comparator | Dosed orally, once daily for up to 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mazindol extended release | Drug | Dosed orally, once daily for up to 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ESS Score From Baseline to Week 4 | Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4 | Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 4. PGIc is rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse | Baseline to Week 4 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Camozzi, MD | NLS Pharmaceutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Stanford Sleep Medicine Center |
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| Placebo | Drug | Dosed orally, once daily for up to 4 weeks. |
|
| Redwood City |
| California |
| 94063 |
| United States |
| Pacific Research Network | San Diego | California | 92103 | United States |
| St. Francis Sleep Allergy and Lung Institute | Clearwater | Florida | 33765 | United States |
| Sleep Medicine Specialists of South Florida | Miami | Florida | 33126 | United States |
| Ivetmar Medical Group | Miami | Florida | 33155 | United States |
| The Angel Medical Research Corporation | Miami Lakes | Florida | 33016 | United States |
| Treken Primary care | Atlanta | Georgia | 30315 | United States |
| NeuroTrials Research | Atlanta | Georgia | 30328 | United States |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | United States |
| Hawaii Pacific Neuroscience Clinical Research Center | Honolulu | Hawaii | 96817 | United States |
| The Center For Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Sleep and Attention Disorders | Sterling Heights | Michigan | 48314 | United States |
| Neurology and Sleep Disorders Clinic | Columbia | Missouri | 65212 | United States |
| Carolinas Sleep Specialists | Concord | North Carolina | 28025 | United States |
| Superior Clinical Research, LLC | Goldsboro | North Carolina | 27534 | United States |
| Advanced Respiratory and Sleep Medicine | Huntersville | North Carolina | 28078 | United States |
| Intrepid Research | Cincinnati | Ohio | 45245 | United States |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | United States |
| Dharma PA d/b/a Southwest Family Medicine Associates | Dallas | Texas | 75235 | United States |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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