RVT-101 extension study in subjects with dementia with Lewy Bodies
Research type
Research Study
Full title
A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)
IRAS ID
215044
Contact name
Ian McKeith
Contact email
Sponsor organisation
Axovant Sciences Ltd.
Eudract number
2016-002412-40
Clinicaltrials.gov Identifier
127,379, IND#
Duration of Study in the UK
0 years, 11 months, 12 days
Research summary
This is a phase 2b long-term extension clinical research study of an Investigational Product called RVT-101 in participants with dementia with Lewy bodies (DLB).
DLB is a type of progressive dementia primarily affecting older adults. Currently there are no approved medical treatments for DLB in Europe.
RVT-101 is being tested in this study to evaluate the long-term safety and tolerability of RVT-101 in participants with dementia with Lewy bodies. RVT-101 is not approved for use in any country.
This research study will include about 240 participants who participated in the lead-in study RVT-101-2001 at about 50 study sites globally. Participants who were given 35 mg of RVT-101 in the lead-in study will remain in the same treatment group. Participants who were given 70 mg of RVT-101 in the lead-in study will remain in this same treatment group. Participants who were given placebo (a “sugar” pill) in the lead-in study will be given 70 mg of RVT-101. The participant, caregiver or study doctor will not know which treatment they are assigned to.
Study participation will last approximately 26 weeks, not including the screening period. Participants will return after the screening visit for a total of 6 visits. In addition, a study visit for safety follow-up tests will be performed 2 weeks after the final visit.
The study involves procedures including: physical exams, vital signs (temperature, blood pressure, heart rate, breathing rate, weight, height), neurological exams, a test to assess motor symptoms of DLB, questions about the occurrence of dizziness and falls, blood tests, urine tests, and recordings of the heart, questions about how the participant is feeling and about medications they are taking.
This study is sponsored by Axovant Sciences Ltd.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0399
Date of REC Opinion
30 Jan 2017
REC opinion
Further Information Favourable Opinion