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Trial record 5 of 31 for:    Recruiting Studies | Huntington Disease

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

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).

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: neflamapimod Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: neflamapimod
40 mg hard gelatin capsules, taken twice daily with food.
Drug: neflamapimod
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.
Other: Placebo
matching placebo capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Conway 617-945-0794 jconway@eippharma.com

Locations
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United Kingdom
John Van Geest Centre for Brain Repair Recruiting
Cambridge, United Kingdom, CB2 0PY
Contact: Danielle Daft    01223 334121      
Principal Investigator: Roger Barker, MD         
Sponsors and Collaborators
EIP Pharma Inc
Voisin Consulting, Inc.
Investigators
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Study Director: John Alam, MD EIP Pharma

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Responsible Party: EIP Pharma Inc
ClinicalTrials.gov Identifier: NCT03980938     History of Changes
Other Study ID Numbers: EIP19-NFD-401
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias