Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington Disease
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|ClinicalTrials.gov Identifier: NCT03980938|
Recruitment Status : Terminated (Due to the long delay because of COVID-19 and results from another study suggesting a higher dose may be more beneficial, EIP Pharma decided on October 15th, 2020, to end the trial prematurely.)
First Posted : June 10, 2019
Last Update Posted : August 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Huntington Disease||Drug: neflamapimod Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 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|
|Actual Primary Completion Date :||October 15, 2020|
|Actual Study Completion Date :||October 15, 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.
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): NCT03980938
|John Van Geest Centre for Brain Repair|
|Cambridge, United Kingdom, CB2 0PY|
|Study Director:||John Alam, MD||EIP Pharma|