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Muscarinic Receptor Antagonist

Darifenacin Treatment for Amyotrophic Lateral Sclerosis

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study 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

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability of oral doses of 15 mg darifenacin

Secondary outcome measures

ALS Assessment Questionnaire (ALSAQ5)

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score

Electrical Impedance Myography (EIM)

+4 more

Other outcome measures

Depression and depressive symptoms

Neuromuscular junction innervation

Pharmacodynamics of oral doses of 15 mg darifenacin

+1 more

Trial 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor

395 Previous Clinical Trials

999,347 Total Patients Enrolled

4 Trials studying Amyotrophic Lateral Sclerosis

1,003 Patients Enrolled for Amyotrophic Lateral Sclerosis

Université de MontréalOTHER

214 Previous Clinical Trials

102,741 Total Patients Enrolled

Oliver Blanchard, MDPrincipal InvestigatorMcGill University - Montreal Neurological Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of Darifenacin therapy in individuals?

"Based on our assessment at Power, the safety rating for Darifenacin Treatment is a 2. This classification reflects that there exists certain data affirming its safety in this Phase 2 trial, albeit lacking evidence of efficacy."

Answered by AI

Are individuals above the age of 40 eligible to participate in this clinical trial?

"Participants eligible for this study must fall within the age bracket of 18 to 85 years. Notably, there are a total of 39 trials catering to individuals under 18 and an additional 393 focusing on those above 65."

Answered by AI

Are patients currently able to participate in this ongoing research study?

"According to clinicaltrials.gov, the trial in question is presently not open for recruitment. Originally shared on 3/1/2024 and last modified on 1/31/2024, this study does not seek participants currently. Nonetheless, there are a total of 527 other trials actively seeking candidates at present."

Answered by AI

Which individuals are eligible to take part in this clinical trial?

"To be eligible for enrollment in this study, individuals must have a diagnosis of amyotrophic lateral sclerosis and fall within the age range of 18 to 85. The trial has a capacity to accept up to 30 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Oliver Blanchard 2024. "A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06249867.

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