Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT04057898
• Date of registration: 06/08/2019
• Prospective Registration: Yes
• Primary sponsor: MediciNova
• Public title: Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS COMBAT-ALS
• Scientific title: A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis
• Date of first enrolment: May 28, 2020
• Target sample size: 230
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04057898
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Kazuko Matsuda, MD PhD MPH
• Affiliation: Medicinova Inc

• Name: Project Management Team

Key inclusion & exclusion criteria

Major Inclusion Criteria:

- Male or female subjects age 18 - 80 years, inclusive;

- Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000)
research diagnostic criteria for ALS [clinically definite, clinically probable,
probable-laboratory-supported];

- ALS onset of =18 months from first clinical signs of weakness prior to screening;

- If currently using riluzole, subject must be on a stable dose for at least 30 days
prior to initiation of study drug;

- If currently using edaravone, subject should have completed at least 14 days of their
initial treatment cycle prior to initiation of study drug;

- Last documented pulmonary function test result (i.e., slow vital capacity or forced
vital capacity) must be greater than or equal to 70% predicted;

- Able to swallow study medication capsules;

- No known allergies to the study drug or its excipients;

- Received pneumococcal vaccine within 6 years prior to starting clinical trial.

Major Exclusion Criteria:

- Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT >3 times
upper limit of normal);

- Currently diagnosed with a clinically significant psychiatric disorder or dementia
that would preclude evaluation of symptoms;

- Currently use or treated with parenteral (intramuscular or intravenous) high dose (>25
mg/week) Vitamin B12 within 30 days prior to study drug administration;

- Poor peripheral venous access that will limit the ability to draw blood as judged by
the Investigator;

- Currently participating, or has participated in a study with an investigational or
marketed compound or device within 30 days or 5 half-lives, whichever is shorter,
prior to signing the informed consent;

- Use of tracheostomy or >22/24-hour ventilatory support.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: placebo

Drug: MN-166

Primary Outcome(s)

Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time. [Time Frame: 12 months]

Secondary Outcome(s)

Responders, measured in percent of subjects overall, whose ALSFRS-R total score was stable or improved [Time Frame: 12 months]

Changes from Baseline in Laboratory Values [Time Frame: 12 months]

Mean change from baseline of functional activity measured by ALSFRS-R at Month 12 [Time Frame: 12 months]

Time to survival [Time Frame: 12 months]

Mean change from baseline of muscle strength measured by hand-held dynamometry [Time Frame: Baseline, Treatment Phase Week 6, Months 3, 6, 9 and12 time points.]

Mean change from baseline on quality of life assessed by ALSAQ-5 at Month 12 [Time Frame: 12 months]

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Time Frame: 12 months]

Secondary ID(s)

MN-166-ALS-2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors