Trial record 1 of 2 for:
Nelotanserin | Hallucinations, parkinson, Lewy body dementia
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
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| ClinicalTrials.gov Identifier: NCT02871427 |
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Recruitment Status :
Terminated
(Changes to the overall development program for the study medication)
First Posted : August 18, 2016
Last Update Posted : March 27, 2019
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Sponsor:
Axovant Sciences Ltd.
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lewy Body Dementia Dementia With Lewy Bodies Parkinson's Disease Dementia Visual Hallucinations REM Sleep Behavior Disorder | Drug: Nelotanserin | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder |
| Actual Study Start Date : | October 20, 2016 |
| Actual Primary Completion Date : | January 17, 2019 |
| Actual Study Completion Date : | January 17, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
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Drug: Nelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose |
Primary Outcome Measures :
- 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. [ Time Frame: 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. [ Time Frame: 24 weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with LBD who completed a previous nelotanserin VH or RBD study
Exclusion Criteria:
- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871427
Locations
Show 19 study locations
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
| Study Director: | Ilise Lombardo, MD | Axovant Sciences, Inc., Clinical Research |
Additional Information:
| Responsible Party: | Axovant Sciences Ltd. |
| ClinicalTrials.gov Identifier: | NCT02871427 |
| Other Study ID Numbers: |
RVT-102-2003 |
| First Posted: | August 18, 2016 Key Record Dates |
| Last Update Posted: | March 27, 2019 |
| Last Verified: | March 2019 |
Keywords provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
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Lewy body dementia Dementia with Lewy bodies Parkinson's disease dementia Visual hallucinations REM sleep behavior disorder |
Additional relevant MeSH terms:
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Parkinson Disease Dementia Hallucinations Lewy Body Disease Alzheimer Disease REM Sleep Behavior Disorder Disease Mental Disorders Pathologic Processes Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Neurocognitive Disorders Tauopathies Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations REM Sleep Parasomnias Parasomnias Sleep Wake Disorders |