COMBAT-ALS

Full Name

A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, 12 month clinical trial to evaluate the efficacy and safety of MN-166 (Ibudilast) followed by an open-label extension in subjects with Amyotrophic Lateral Sclerosis (ALS).

Description

COMBAT-ALS is a Phase 2b/3 multicenter (conducted at 19 hospitals across the US and Canada, including LVHN), randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MN-166 (Ibudilast) in subjects diagnosed with ALS. “Randomized” and “double-blinded” means that participants enrolled in the trial will be randomly assigned to two groups (one group will take MN-166 and the other group will take placebo, or a “sugar pill”), and neither the participants nor the study doctors/nurses will know which group any of the study participants are assigned to. Participants will have a 50/50 chance (like a coin flip) of being entered into the MN-166 or placebo group. Participants will take the study medication/placebo twice daily in pill form for 12 months. At the end of 12 months, participants will have the option to remain in the trial for an additional 6 months as part of the “open-label phase;” an “open-label phase” is a part of a clinical trial where everyone receives the study medication (MN-166 in this case) and no one is on placebo anymore.

Participants will be enrolled at Lehigh Valley Health Network-Cedar Crest’s Neurology Office by one of the department’s ALS specialists. During study visits, which occur every 3 months on average (the first 3 visits are closer together, separated by approximately every 4-6 weeks), participants will be examined by the study doctors to ensure they are still safe to remain in the trial, blood work will be obtained, participants will answer a few survey questions, and the study doctors will test the participant’s muscular strength. In between office visits, participants will be contacted by phone by the study nurse coordinating the study to ensure participants are still safe to remain in the trial, to ensure none of the participant’s regularly-prescribed medications have changed, and to answer any questions.

Purpose: Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s Disease) is a progressive, degenerative neurological disorder with no known cure. The purpose of COMBAT-ALS is to determine the efficacy (how well the study medication works at slowing the progression of ALS) and safety of MN-166, an anti-inflammatory medication known as Ibudilast outside the US.

To Participate: Please contact the Network Office of Research and Innovation at 610-402-9543.

For additional information:

https://clinicaltrials.gov/ct2/show/NCT04057898

Eligibility

Inclusion Criteria

Male or female subjects age 18 to 80 years, inclusive;
Diagnosis of familial or sporadic ALS
ALS onset of ≤ 18 months from first clinical symptoms of weakness prior to screening
Last documented pulmonary function result (i.e., slow vital capacity or forced vital capacity) must be ≥70% of predicted
Female subjects of childbearing potential must use one or more effective methods of contraception throughout the entire study period and for 30 days after study drug discontinuation
Male subjects agree to practice contraception (e.g., condom use and contraception by female partner) throughout the entire study period and for 30 days after study drug discontinuation;
Able to swallow study medication capsules
At clinical sites where the pneumococcal vaccine is available and administered as standard of care, has received pneumococcal vaccine within 6 years prior to starting clinical trial.