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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02871427
Other study ID # RVT-102-2003
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 20, 2016
Est. completion date January 17, 2019

Study information

Verified date March 2019
Source Axovant Sciences Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 80
Est. completion date January 17, 2019
Est. primary completion date January 17, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Nelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Locations

Country Name City State
United States US120 Birmingham Alabama
United States US114 Boca Raton Florida
United States US101 Chapel Hill North Carolina
United States US111 Cincinnati Ohio
United States US104 Cleveland Ohio
United States US105 Columbus Ohio
United States US147 Fargo North Dakota
United States US107 Indianapolis Indiana
United States US132 Lenexa Kansas
United States US129 Lincoln Nebraska
United States US173 Lincoln Rhode Island
United States US143 Little Rock Arkansas
United States US180 Maitland Florida
United States US128 Memphis Tennessee
United States US154 Ocala Florida
United States US113 Orlando Florida
United States US152 Ormond Beach Florida
United States US103 Rochester Minnesota
United States US131 San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Axovant Sciences Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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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