Amyotrophic Lateral Sclerosis study: Darifenacin
Official title A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS
ClinicalTrials.gov ID: NCT06249867
What this study is testing
What is Darifenacin 7.5 MG Extended Release Oral Tablet?
An investigational oral tablet being studied for amyotrophic lateral sclerosis (ALS).
Also referred to as Darifenacin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if darifenacin is safe and well tolerated in ALS patients and to learn how it affects the body and nerves.
- Who it's for
- Adults aged 18 to 85 who have been diagnosed with amyotrophic lateral sclerosis (ALS).
- What's involved
- Participants will take a daily pill of either 7.5 mg darifenacin or a placebo for two weeks, then 15 mg for the next 22 weeks. They will have regular check‑ups and tests to monitor safety, muscle strength, nerve function, mood, and nerve‑muscle connections.
- Time commitment
- The study lasts about 24 weeks, with visits and tests scheduled throughout that period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Male or female, ≥ 18 years old and ≤85 years old, at the time of signing the ICF.
- Confirmed diagnosis of familial or sporadic ALS, defined as meeting the probable, laboratory-supported probable, or definite criteria for a diagnosis...
- ALS duration of less than 36 months from the symptom onset.
- FVC of ≥ 50 %.
You likely can't join if
- Untreated or uncontrolled narrow-angle glaucoma;
- Gastric retention
- Urinary retention
- Liver disease
- Patients with a known history of severe allergic or anaphylactic reactions to antimuscarinic medications
- If diagnosed with another neurodegenerative disease (e.g. Multiple Sclerosis, Parkinson, Myasthenia Gravis, and Alzheimer's disease).
See the full eligibility criteria
Who can join
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Male or female, ≥ 18 years old and ≤85 years old, at the time of signing the ICF.
- Confirmed diagnosis of familial or sporadic ALS, defined as meeting the probable, laboratory-supported probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology Modified El...
- ALS duration of less than 36 months from the symptom onset.
- FVC of ≥ 50 %.
- Able to swallow tablets without crushing.
- A female patient is eligible to participate if she is not breastfeeding, has negative pregnancy test at screening, has no intention of becoming pregnant during the course of the study, and agrees to use appropriate...
- If male and has a partner who may become pregnant, agrees to ensure that he and/or his partner use a reliable form of birth control (as defined in section 3.4 of the study protocol) for the duration of the study and...
- In the case of taking Riluzole, the patient must have been on a stable dose at least 30 days prior to start date.
- In the case of taking Edaravone, the patient must have been on a stable dose at least 30 days prior to start date.
- In the case of receiving Albrioza, the patient must have been on a stable dose at least 30 days prior to start date.
- Participants with normal platelet or coagulation test values.
- Participants who are receiving anticoagulant medications will need to abstain from using anticoagulants for a specific number of days before and after the biopsy, as decided by the study doctor on a case-by-case basis.
What rules you out
- Untreated or uncontrolled narrow-angle glaucoma;
- Gastric retention
- Urinary retention
- Liver disease
- Patients with a known history of severe allergic or anaphylactic reactions to antimuscarinic medications
- If diagnosed with another neurodegenerative disease (e.g. Multiple Sclerosis, Parkinson, Myasthenia Gravis, and Alzheimer's disease).
- people with severe hepatic impairment or abnormal liver enzymes, as defined as Child-Pugh B and C scores.
- Subject has a history of, or positive test result at Screening, for hepatitis C virus antibody.
- people with acute or prolonged hepatitis B \& C.
- Any medical condition that might interfere with the patient's participation in the trial, poses any added risk for the patient, or confounds the assessment of the patient according to the Investigator's judgement.
- people with any uncontrolled (unresolved) medical condition other than ALS, as determined by the Investigator.
- people who are currently enrolled in another clinical trial and receiving an Investigational Product (IP) (including but not limited to stem cell therapy or gene therapy).
- Treatment with an investigational drug within 1 month or within a time period equal to 5 half-lives (if known) whichever is longer, of starting study treatment.
- Patients with prior darifenacin treatment.
- History of drug and/or alcohol abuse (according to Diagnostic and Statistical Manual of Mental Disorders) prior to the screening as determined by the Investigator.
- If female, people who are pregnant, breastfeeding, or intending to conceive during the course of the study.
- people with an abnormal electrocardiogram (ECG) at screening (any abnormality that the PI believes that entering the study place the participant at risk).
- people who are receiving strong CYP3A4 inducers such as carbamazepine (anticonvulsant), phenytoin (anticonvulsant), rifampin (antibiotic), and modafinil (wakefulness-promoting agent).
- people who are receiving potent CYP3A4 inhibitors such as clarithromycin (macrolide antibiotic), ketoconazole and itraconazole (antifungal medications), nefazadone (antidepressant), nelfinavir and ritonavir (protease...
- people who are receiving or received within 30 days prior to the starting of the trial CYP2D6 substrates with a narrow therapeutic window such as include flecainide (Class IC anti-arrhythmic), thioridazine...
- people who are receiving or received intramuscular botulinum injections in the arms, legs, or face in the past 6 months.
- people who are receiving or received within 30 days prior to the starting of the trial antimuscarinic medications for the treatment of overactive bladder such as fesoterodine, oxybutynin, solifenacin, tolterodine, and...
- Only for patients that consented to the Optional Needle Muscle Biopsy procedures.
- Subject is taking an anticoagulant (with the exception of aspirin at the investigator's discretion) or is at risk of increased or uncontrolled muscle biopsy-related bleeding.
- people with bleeding risk factors which include, but are not limited to, anatomical factors at or near the muscle biopsy site (e.g., vascular abnormalities, neoplasms, or other abnormalities) or abnormal platelet or...
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
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, but 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 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ottawa, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.