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Tests treatment safety and results for Amyotrophic Lateral Sclerosis
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?
Darifenacin 7.5 MG Extended Release Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for amyotrophic lateral sclerosis.
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
- Amyotrophic lateral sclerosis (ALS) is a progressive neurological disorder characterized by selective death of upper and lower motor neurons, which leads to severe disability and fatal outcomes. One of the major hallmarks of ALS is the denervation of neuromuscular junctions (NMJs), which is one of the earliest events seen in ALS patients and mouse models of ALS.
- 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
- Patients with, or at risk for, the following conditions:
- 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
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...
- Participants receiving standard care for ALS prior to entering the trial (i.e. Riluzole, Edaravone, and Albrioza), must be on a stable dosing regimen prior to the randomization and agree to remain on this dosage during...
- 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.
- For participants who consent to the optional biopsy:
- 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
- Patients with, or at risk for, the following conditions:
- 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 botulinum injections 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's taking place
- 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 - 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?
Study sites include Ottawa, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.