A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 8, 2024

Primary Completion Date

August 31, 2027

Study Completion Date

September 30, 2027

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

Darifenacin 7.5 MG Extended Release Oral Tablet

During the first two weeks (titration period), patients in the treatment arm will receive a daily dose of 7.5 mg darifenacin extended-release tablet. After the titration period, the dose will be increased to 15 mg once daily, which consists of two 7.5 mg tablets together for a period of 22 weeks.

DRUG

Placebo

During the first two weeks (titration period), patients in the placebo arm will receive a daily dose of 1 placebo tablet. After the titration period, the dose will be increased to two placebo tablets taken together, for a period of 22 weeks.

Trial Locations (2)

K1Y 4E9

RECRUITING

Ottawa Hospital Research Institute, Ottawa

H3A 2B4

RECRUITING

Montreal Neurological Institute, Montreal

All Listed Sponsors
collaborator

Université de Montréal

OTHER

lead

Oliver Blanchard

OTHER