FORTITUDE-ALS is a clinical trial which is designed to evaluate whether CK-2127107 has an effect on participants with amyotrophic lateral sclerosis (ALS) and what kind of side effects may occur in these participants taking CK-2127107.
CK-2127107 acts on muscle contraction and may result in increased muscle force and increased time to muscle fatigue. Based on how it acts, CK-2127107 may help improve the force of muscle contraction when there is reduced nerve input to the muscle in diseases like ALS.
FORTITUDE-ALS will evaluate the effects of CK-2127107 compared to placebo on muscle performance, including effects on muscles associated with breathing, movement, and speaking, as well as on overall physical function.
FORTlTUDE-ALS is now enrolling:
- adult participants
- diagnosed with ALS
- at sites in the United States and Canada
Qualified participants may receive travel reimbursement.
FORTITUDE-ALS is a placebo-controlled clinical trial. This means that some participants will receive the investigational medicine while others will receive a placebo (a pill with inactive ingredients). Approximately 450 eligible participants with ALS from centers in the U.S. and Canada will be assigned to receive either 150 mg, 300 mg or 450 mg of CK-2127107 or placebo for 12 weeks. The assignment of participants to each group is done at random, like flipping a coin, but in a way that three times more participants will receive investigational medicine than placebo (3:1 ratio). Neither the patient nor the trial doctor will know the treatment assignment.
CK-2127107 is an investigational medicine which means that it is not approved by the FDA or by Health Canada.
Additional information about FORTITUDE-ALS can be found at clinicaltrials.gov.
FORTITUDE-ALS: Trial Sites
The following clinical trial sites in the United States and Canada are enrolling participants in FORTITUDE-ALS. Please click on a pin to find out more about that location. To see if you may be eligible to participate in this clinical trial, please click here.