The ROCK-ALS trial recruits patients with amyotrophic lateral sclerosis since 2019. The following inclusion and exclusion criteria are effective:
Inclusion criteria (excerpt):
- Probable or definite ALS according to the revised El Escorial WFN criteria
- Disease duration> 6 and < 24 months (inclusive)
- ageā„18 years
- stable treatment with Riluzole 2 x 50 mg for at least 4 weeks
- Women of childbearing age must be non-lactating and sterile or using effective methods of birth control and have a negative pregnancy test
Exclusion criteria (excerpt):
- Previous participation in another clinical study involving trial medication within the preceding 12 weeks,
- Tracheostomy or assisted ventilation of any type during the preceding three months or a significant pulmonary disorder not attributed to ALS complicating the evaluation of respiratory function,
- Patients with a history of intracranial bleeding, known intracerebral aneurysms or Moya-Moya disease,
- Gastrostomy,
- Pregnant or breast-feeding females or females with childbearing potential, if no adequate contraceptive measures are used.
If you treat patients with amyotrophic lateral sclerosis who could be interested to participate in the ROCK-ALS trial, please refer them to the study center closest to you. A listing of contact adresses can be found here: