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WALKALS : A pilot phase II study to evaluate the effect of salbutamol on walking capacity in ambulatory ALS patients.
EU CTIS ID: 2022-501624-14-00
What this study is testing
To test the efficacy of salbutamol on walking capacity in ALS patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Subjects who meet the revised El Escorial criteria for probable or definite sporadic ALS - Adult patients between 18 and 75 years of age - Patients who are ambulatory and able to perform the 6MWT and quantitative muscle testing at screening (ALSFRS-R-walking = 3) - Patients able and willing to travel to the site, and, in the investigator’s opinion, who are likely to attend visits for at least 6 months - Patients who signed written informed consent - Stable dose of riluzole for a minimum of 14 day4 weeks prior to baseline or has not taken it for 14 days4 weeks prior to baseline - Affiliation to French social security system excluding AME - For child-bearing aged women, efficient contraception - Forced vital capacity (fVC) in a sitting position > 70 %
You likely can't join if
- - Patients with significant spasticity of the lower limbs interfering with walking capacity (Ashworth scale score 2) - Patients with fronto-temporal dementia associated with ALS - Patients presenting respiratory insufficiency causing dyspnea during walking - Patients taking drugs that could interfere with NMJ function (anticholinesterase …) or muscle function (steroids, statins…)- Patients taking any forbidden drugs (see list in annex) - Hypersensitivity to salbutamol or to excipients of the drug and placebo - Known contraindication for the studied drug such as ischemic cardiomyopathy or risk of ischemic cardiomyopathy - Pregnancy or women seeking a pregnancy during the study or breastfeeding - Patients under curatorship or guardianship - Participation in another interventional trial up to 3 months before inclusion - Patients having any relevant concomitant disease considered at risk of interfering with study procedures in the opinion of the investigator - Patients not affiliated to the French social security system
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.