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This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).
This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD.
Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelotanserin | Experimental | Nelotanserin 80 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelotanserin | Drug | once daily, oral, 20-mg tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents. | 28 days |
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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 | ||
| US164 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33714847 | Derived | Stefani A, Santamaria J, Iranzo A, Hackner H, Schenck CH, Hogl B. Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson's disease dementia. Sleep Med. 2021 May;81:180-187. doi: 10.1016/j.sleep.2021.02.038. Epub 2021 Feb 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelotanserin | Nelotanserin 80 mg Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2018 |
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| Drug |
once daily, oral, matching tablets |
|
| Phoenix |
| Arizona |
| 85013 |
| United States |
| US145 | Sun City | Arizona | 85351 | United States |
| US143 | Little Rock | Arkansas | 72205 | United States |
| US122 | Englewood | Colorado | 80113 | 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 |
| US153 | Tampa | Florida | 33613 | United States |
| US163 | Atlanta | Georgia | 30331 | United States |
| US107 | Indianapolis | Indiana | 46202 | United States |
| US132 | Lenexa | Kansas | 66214 | United States |
| US129 | Lincoln | Nebraska | 68526 | United States |
| US101 | Chapel Hill | North Carolina | 27514 | United States |
| US159 | New Bern | North Carolina | 28562 | 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 | 38613 | United States |
| US131 | San Antonio | Texas | 78229 | United States |
Placebo
Placebo: once daily, oral, matching tablets
| COMPLETED |
|
| NOT COMPLETED |
|
The Safety population included subjects who took at least 1 dose of double-blind study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Nelotanserin | Nelotanserin 80 mg Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin. |
| BG001 | Placebo | Placebo Placebo: once daily, oral, matching tablets |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents. | Posted | Least Squares Mean | Standard Error | Number of RBD per 10 min | 28 days |
|
|
|
11 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nelotanserin | Nelotanserin 80 mg Nelotanserin: once daily, oral, 20-mg tablets | 0 | 16 | 2 | 16 | 11 | 16 |
| EG001 | Placebo | Placebo Placebo: once daily, oral, matching tablets | 0 | 18 | 0 | 18 | 8 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Research | Axovant Sciences GMBH | 1-833-296-8268 | clinicaltrials@axovant.com |
| Apr 29, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| 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 |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C546600 | nelotanserin |
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| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|