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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT03980938
• Date of registration: 07/06/2019
• Prospective Registration: Yes
• Primary sponsor: EIP Pharma Inc
• Public title: Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington Disease
• Scientific 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)
• Date of first enrolment: July 8, 2019
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03980938
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: John Alam, MD
• Affiliation: EIP Pharma

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Huntington Disease

Intervention(s)

Other: Placebo

Drug: neflamapimod

Primary Outcome(s)

Change in Latency During the Learning Phase of Virtual Morris Water Maze Test (vMWM) [Time Frame: Baseline and 10 Weeks]

Secondary ID(s)

EIP19-NFD-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Voisin Consulting, Inc.

Results

• Results available: Yes
• Date Posted: 06/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03980938