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Muscarinic Receptor Antagonist
Darifenacin for ALS
Montréal, Canada
Phase 2
Recruiting
Led By Oliver Blanchard, MD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, aged between 18 and 85 years at the time of signing the ICF
Confirmed diagnosis of familial or sporadic ALS according to the World Federation of Neurology Modified El Escorial criteria
Must not have
Untreated or uncontrolled narrow-angle glaucoma
Receiving CYP2D6 substrates with a narrow therapeutic window
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Summary
"This trial aims to test the safety and effectiveness of a drug called Darifenacin in patients with Amyotrophic Lateral Sclerosis (ALS). ALS is a disease that causes the death of nerve cells
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Who is the study for?
This trial is for people aged 18-85 with ALS, a progressive neurological disorder. Participants will be taking Darifenacin or a placebo to see if it can help maintain nerve and muscle connections by influencing certain cells at the neuromuscular junction.Check my eligibility
What is being tested?
The study tests Darifenacin's safety and effects in ALS patients. It involves taking a daily dose of this medication for six months, starting with 7.5 mg and increasing to 15 mg after two weeks, compared to a placebo.See study design
What are the potential side effects?
Potential side effects of Darifenacin include dry mouth, constipation, headache, dizziness, blurred vision, urinary retention or infection; however specific side effects related to ALS patients will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
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I have been diagnosed with ALS.
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I can swallow pills without needing to crush them.
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I agree to use birth control and not donate sperm as my partner could become pregnant.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have untreated or uncontrolled narrow-angle glaucoma.
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I am taking medication that is sensitive to changes in how my body processes drugs.
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I am on blood thinners or have a high risk of bleeding from a muscle biopsy.
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I have a high risk of bleeding due to certain conditions or test results.
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I have problems with my stomach emptying.
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I have trouble emptying my bladder completely.
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I have severe liver problems or abnormal liver tests.
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I do not have any uncontrolled health conditions besides ALS.
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I am taking medication that strongly affects liver enzyme levels.
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I have been diagnosed with a neurodegenerative disease.
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I have been treated with darifenacin before.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of oral doses of 15 mg darifenacin
Secondary study objectives
ALS Assessment Questionnaire (ALSAQ5)
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score
Electrical Impedance Myography (EIM)
+4 moreOther study objectives
Depression and depressive symptoms
Neuromuscular junction innervation
Pharmacodynamics of oral doses of 15 mg darifenacin
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Darifenacin TreatmentExperimental Treatment1 Intervention
Patients in the Treatment arm will receive a daily dose of 1 or 2 darifenacin extended-release tablets.
Group II: PlaceboPlacebo Group1 Intervention
Patients in the Placebo arm will receive a daily dose of 1 or 2 placebo tablets.
Find a Location
Closest Location:Montreal Neurological Institute· Montréal, Canada
Who is running the clinical trial?
McGill UniversityLead Sponsor
419 Previous Clinical Trials
1,017,274 Total Patients Enrolled
4 Trials studying Amyotrophic Lateral Sclerosis
1,003 Patients Enrolled for Amyotrophic Lateral Sclerosis
Université de MontréalOTHER
222 Previous Clinical Trials
104,335 Total Patients Enrolled
Oliver Blanchard, MDPrincipal InvestigatorMcGill University - Montreal Neurological Institute