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

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ClinicalTrials.gov Identifier: NCT03980938
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Voisin Consulting, Inc.
Information provided by (Responsible Party):
EIP Pharma Inc

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE July 8, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington Disease
Official Title  ICMJE 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)
Brief 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE
  • Drug: neflamapimod
    40 mg neflamapimod capsule
    Other Name: VX-745
  • Other: Placebo
    matching placebo capsule
Study Arms  ICMJE
  • Experimental: neflamapimod
    40 mg hard gelatin capsules, taken twice daily with food.
    Intervention: Drug: neflamapimod
  • Placebo Comparator: placebo
    hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women age 30 to 70 years, inclusive.
  2. Willing and able to provide informed consent.
  3. Must have genetically confirmed HD and identified cognitive deficits:

    1. Stage 1, as defined by Unified Huntington's Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) score >10, and,
    2. CANTAB Paired Associate Learning Total Adjusted Error Score of >16.
  4. Normal or corrected eye sight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
  5. No history of learning difficulties that may interfere with the subject's ability to complete the cognitive tests.

Exclusion Criteria:

  1. A profile of impairment that is not consistent with HD.
  2. Diagnosis of any other ongoing central nervous system condition other than HD, including, but not limited to, vascular dementia, dementia with Lewy bodies, and Parkinson's disease.
  3. Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide.
  4. Ongoing major and active psychiatric disorder, moderate to severe depressive symptoms, and or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements.
  5. Diagnosis of alcohol or drug abuse within the previous 2 years.
  6. Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude treatment with p38 mitogen activated protein (MAP) kinase inhibitor and/or assessment of drug safety and efficacy.
  7. Anemia with a hemoglobin ≤10 g/dL, clinically significant thyroid function abnormality, electrolyte abnormalities.
  8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5.
  9. Known human immunodeficiency virus; or active hepatitis B or hepatitis C virus infection; evidence of active or latent tuberculosis.
  10. Subject participated in a study of an investigational drug less than 3 months or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study.
  11. History of previous neurosurgery to the brain.
  12. Female subjects who are pregnant or breast-feeding.
  13. Male subjects with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements specified in the protocol (see Section 5.8).
  14. Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy and are not willing or unable to adhere to contraceptive requirements specified in the protocol (see Section 5.8).
  15. Requires concomitant use of cytochrome P450 (CYP) 3A4 inhibitors or anti-tumor necrosis factor-alpha therapies during study participation.
  16. Known allergy to any ingredient of the trial medication or placebo.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Conway 617-945-0794 jconway@eippharma.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980938
Other Study ID Numbers  ICMJE EIP19-NFD-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party EIP Pharma Inc
Study Sponsor  ICMJE EIP Pharma Inc
Collaborators  ICMJE Voisin Consulting, Inc.
Investigators  ICMJE
Study Director: John Alam, MD EIP Pharma
PRS Account EIP Pharma Inc
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP