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Changes to the overall development program for the study medication
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This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).
This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs. Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelotanserin | Experimental | Once Daily, Oral, at 20, 40, 60, or 80 mg dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelotanserin | Drug | Once Daily, Oral, at 20, 40, 60, or 80 mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment. | 24 weeks | |
| Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilise Lombardo, MD | Axovant Sciences, Inc., Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US120 | Birmingham | Alabama | 35294 | United States | ||
| US143 |
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| Label | URL |
|---|---|
| Click on Nelotanserin for more information | View source |
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| Little Rock |
| Arkansas |
| 77205 |
| United States |
| US114 | Boca Raton | Florida | 33486 | United States |
| US180 | Maitland | Florida | 32751 | United States |
| US154 | Ocala | Florida | 34471 | United States |
| US113 | Orlando | Florida | 32806 | United States |
| US152 | Ormond Beach | Florida | 32174 | United States |
| US107 | Indianapolis | Indiana | 46202 | United States |
| US132 | Lenexa | Kansas | 66214 | United States |
| US103 | Rochester | Minnesota | 55905 | United States |
| US129 | Lincoln | Nebraska | 68526 | United States |
| US101 | Chapel Hill | North Carolina | 27514 | United States |
| US147 | Fargo | North Dakota | 58103 | United States |
| US111 | Cincinnati | Ohio | 45229 | United States |
| US104 | Cleveland | Ohio | 44195 | United States |
| US105 | Columbus | Ohio | 43210 | United States |
| US173 | Lincoln | Rhode Island | 02865 | United States |
| US128 | Memphis | Tennessee | 38163 | United States |
| US131 | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D006212 | Hallucinations |
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C546600 | nelotanserin |
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