Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington Disease
|ClinicalTrials.gov Identifier: NCT03980938|
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Huntington Disease||Drug: neflamapimod Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo-Controlled Two-Period 10-Week Treatment Within-Subject Crossover Study Of Cognitive Effects Of Neflamapimod in Early-Stage Huntington Disease (HD)|
|Actual Study Start Date :||July 8, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||July 2020|
40 mg hard gelatin capsules, taken twice daily with food.
40 mg neflamapimod capsule
Other Name: VX-745
Placebo Comparator: placebo
hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food.
matching placebo capsule
- the effects of administration of neflamapimod on hippocampal function, as assessed in [ Time Frame: 20 Weeks ]Latency during the learning phase of virtual Morris Water Maze (MWM).l MWM (hidden platform training) during the neflamapimod-treatment period compared to that during the placebo-administration period.
- Additional assessment of hippocampal function by MWM [ Time Frame: 20 Weeks ]Percent of time spent in the correct quadrant during MWM probe test during the neflamapimod-treatment period compared to that during the placebo-administration period.
- To evaluate the effects of neflamapimod on the Cambridge Neuropsychological Test Automated Battery (CANTAB) paired associates learning task. [ Time Frame: 20 Weeks ]Number of overall errors in the CANTAB paired associates learning task, in addition to larger battery, during the neflamapimod-treatment period compared to that during the placebo-administration period.
- To evaluate tolerability and safety of neflamapimod in subjects with HD. [ Time Frame: 20 Weeks ]Safety as determined by the number of related adverse events and general tolerability reported during the neflamapimod treatment period compared to the placebo administration period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980938
|Contact: Jennifer Conwayfirstname.lastname@example.org|
|John Van Geest Centre for Brain Repair||Recruiting|
|Cambridge, United Kingdom, CB2 0PY|
|Contact: Danielle Daft 01223 334121|
|Principal Investigator: Roger Barker, MD|
|Study Director:||John Alam, MD||EIP Pharma|