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NCT03980938

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

Terminated Phase 2 Results posted Last updated 6 April 2022
What this trial tests

Phase 2 trial testing neflamapimod in Huntington Disease in 15 participants. Terminated before completion.

Timeline
8 July 2019
Primary endpoint
15 October 2020
15 October 2020

Quick facts

Lead sponsorEIP Pharma Inc
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment15
Start date8 July 2019
Primary completion15 October 2020
Estimated completion15 October 2020
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

EIP Pharma Inc

Who can join

Adults 30 to 70, any sex, with Huntington Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Latency During the Learning Phase of Virtual Morris Water Maze Test (vMWM) Primary · Baseline and 10 Weeks

Change from baseline of latency during the learning phase of vMWM (hidden platform training) in the neflamapimod first group compared to placebo first group

GroupValue95% CI
Neflamapimod First-6.92± 3.814
Placebo First-14.05± 12.680

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 37 weeks. AEs occurring from when the subject signed the ICF until up to 30 days after the last dose were collected. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Neflamapimod First
Serious: 0/7 (0%)
Deaths: 0
Placebo First
Serious: 0/8 (0%)
Deaths: 0
Other adverse events (9 terms — click to expand)

ReactionSystemNeflamapimod FirstPlacebo First
Common ColdInfections and infestations
DiarrheaGastrointestinal disorders
NauseaGastrointestinal disorders
SoresInfections and infestations
SinusitisInfections and infestations
Increased AnxietyPsychiatric disorders
Abdominal PainGastrointestinal disorders
HeadacheNervous system disorders
Urinary Tract InfectionInfections and infestations

Data from ClinicalTrials.gov NCT03980938 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Diversity and versatility of p38 kinase signalling in health and disease.
    Canovas B, Nebreda AR. · · 2021 · cited 466× · PMID 33504982 · DOI 10.1038/s41580-020-00322-w
  2. New Avenues for the Treatment of Huntington's Disease.
    Kim A, Lalonde K, Truesdell A, Gomes Welter P, et al · · 2021 · cited 130× · PMID 34445070 · DOI 10.3390/ijms22168363
  3. From Pathogenesis to Therapeutics: A Review of 150 Years of Huntington's Disease Research.
    Jiang A, Handley RR, Lehnert K, Snell RG. · · 2023 · cited 88× · PMID 37629202 · DOI 10.3390/ijms241613021
  4. Current and Possible Future Therapeutic Options for Huntington's Disease.
    Ferguson MW, Kennedy CJ, Palpagama TH, Waldvogel HJ, et al · · 2022 · cited 66× · PMID 35615642 · DOI 10.1177/11795735221092517
  5. Atypical p38 Signaling, Activation, and Implications for Disease.
    Burton JC, Antoniades W, Okalova J, Roos MM, et al · · 2021 · cited 52× · PMID 33920735 · DOI 10.3390/ijms22084183
  6. Clinically Precedented Protein Kinases: Rationale for Their Use in Neurodegenerative Disease.
    Benn CL, Dawson LA. · · 2020 · cited 36× · PMID 33117143 · DOI 10.3389/fnagi.2020.00242
  7. Therapeutic Update on Huntington's Disease: Symptomatic Treatments and Emerging Disease-Modifying Therapies.
    Dash D, Mestre TA. · · 2020 · cited 35× · PMID 32705582 · DOI 10.1007/s13311-020-00891-w
  8. Huntington's Disease Clinical Trials Corner: March 2024.
    Estevez-Fraga C, Tabrizi SJ, Wild EJ. · · 2024 · cited 31× · PMID 38489195 · DOI 10.3233/jhd-240017

Verify or expand the search:

Other trials of neflamapimod

Trials testing the same drug.

Other recruiting trials for Huntington Disease

Currently open trials in the same condition.

Other EIP Pharma Inc trials

Trials by the same sponsor.

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