What is amyotrophic lateral sclerosis?

Amyotrophic lateral sclerosis, (ALS or Lou-Gehrig’s disease) is a rare disorder of the nervous system, which results in progressive muscle weakness and death by paralysis of the respiratory muscles within several years following the diagnosis.No curative treatment exists until now.

What is Fasudil?

Fasudil is a drug, which has been licensed for several years in Japan for the treatment of patients with subarachnoid hemorrhage. It appears to have a very good safety profile. Studies in cell cultures and mouse models of ALS demonstrated numerous beneficial effects of Fasudil. For example, Fasudil improved survival and motor performance in the ALS mouse model. It also showed a number of promising effects in other models of neurodegenerative disorders.

What is ROCK-ALS?

ROCK-ALS is a clinical phase IIa trial, which will assess safety, tolerability and efficacy of Fasudil in patients with ALS. In the trial, Fasudil will be applied for 20 days twice daily as intravenous infusion. Clinical and technical exams will assess if the substance is well tolerated in patients with ALS and if it can beneficially influence disease progression. In addition, biomaterials (e.g. CSF, blood, urine) will be collected, to establish better biomarkers for the disease in the future. Patients, who participate in the trial, will also have regular follow-up examinations after the treatment period with several visits up to 180 days after the start of the treatment.

How can I participate in ROCK-ALS?

Clinical trials are subjected to very rigorous due diligence. This also requires patients to fulfill very specific inclusion criteria. If you are diagnosed with ALS and your first symptoms appeared less than 24 months ago, you could be a candidate for participation in this trial.

For further information, please refer to the trial office: