NCT03980938

Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington Disease

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: EIP Pharma Inc · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, placebo-controlled 2-period 10-week treatment within-subject crossover study of neflamapimod in early-stage Huntington disease (HD). The primary objective is to determine whether neflamapimod can reverse hippocampal dysfunction in patients with early-stage HD, as assessed by the virtual water-maze-test for evaluating spatial learning and selected tests on the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Detailed description

The study was designed as within-subject crossover study. However, due to the Covid19 lockdowns and restrictions on clinical research, and only one subject entered the second crossover period. As a result, the baseline and outcomes are reported by the actual treatment received in the subjects during what would have been the first treatment period, i.e. placebo or neflamapimod treatment.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	neflamapimod	40 mg neflamapimod capsule
OTHER	Placebo	matching placebo capsule

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2019-06-10
• Last updated: 2022-04-06
• Results posted: 2022-04-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study