Therapeutic clinical trials are an essential form of clinical research designed to test whether a drug or device is 1) safe to use, and/or 2) whether it leads to a change in disease trajectory or symptom management, in our case ALS.
In most therapeutic clinical trials, participants are randomized to an intervention (such as a drug) or a placebo (an inactive substance) in a double-blinded manner, meaning that neither the participant nor the clinical trial team knows the treatment assignment (meaning whether the participant is taking drug or placebo).
Once all participants complete the study, or if the trial is stopped for other reasons, the researchers will analyze the data to determine if the intervention was beneficial and/or safe.
Even if a clinical trial does not directly benefit a study participant, it does benefit others living with the disease, either now or in the future.
Ongoing Trials:
Healey Center Platform Trial for ALS
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. In this trial, multiple drugs for ALS will be tested simultaneously or sequentially. Each drug will be tested in a regimen, which also consists of a placebo-controlled trial, meaning that the active drug and matching placebo will be tested in each regimen.
We are not currently enrolling study participants. If you are interested in being involved in future studies, please get in touch with Jayna Duell at 734-936-8776 or [email protected].
Completed Trials:
Safety Study of Oral Edaravone Administered in Subjects With ALS
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS (REFALS)
AMX0035 in Patients With Amyotrophic Lateral Sclerosis (CENTAUR)
Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (Mexiletine-2)
Clinical Trial of Ezogabine (Retigabine) in ALS Subjects
Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)
Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)
For questions on clinical trials at the University of Michigan, please email Jayna Duell at [email protected]
