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This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NLS-2 (mazindol extended release) | Experimental | NLS-2 (mazindol extended release) administered once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mazindol | Drug | Drug: NLS-2 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2) | Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE. | 24 weeks |
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Inclusion Criteria:
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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| 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 |
| 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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| ID | Term |
|---|---|
| D008454 | Mazindol |
| ID | Term |
|---|---|
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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