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Potassium Channel Blocker
Dalfampridine for ALS
Phase 1
Waitlist Available
Led By Dale Lange, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No current or exposure to any therapeutic agent targeting PLS or ALS within 30 days of enrollment
Impaired walking as measured by a Hauser Index of greater than 1 and less than 7 (2 to 6, inclusive)
Must not have
Active cancer within the previous 2 years, except treated basal cell carcinoma of the skin
Patient has been administered botulinum toxin in the lower extremities within 6 months prior to the screening visit and/or is expected to receive botulinum toxin in the lower extremities during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of study at weeks 2, 4, 6, 10, 14, 18
Awards & highlights
Summary
This trial is testing a new medication, ropinirole hydrochloride, to see if it is safe and can be tolerated by patients. It focuses on people with specific motor neuron diseases, PLS or upper motor neuron predominant ALS. The effectiveness of the medication will be measured by checking if patients can walk faster over a short distance.
Who is the study for?
This trial is for adults aged 18-99 with primary lateral sclerosis (PLS) or upper motor neuron predominant ALS. Participants must have stable walking impairment, no severe allergies to dalfampridine, and a forced vital capacity over 60%. Women must use effective birth control. Exclusions include pregnancy, recent experimental drug use, certain medical conditions like liver disease or seizures, and metal implants above the neck.
What is being tested?
The study tests the safety and effectiveness of dalfampridine in improving walking speed in PLS/ALS patients over an 18-week period. It involves repeated timed walks to measure any improvement while on medication compared to baseline performance without medication.
What are the potential side effects?
Dalfampridine can cause side effects such as difficulty sleeping, dizziness, nausea, headache, weakness, back pain and balance problems. In rare cases it may increase seizure risk; hence it's not given to those with a history of seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken any drugs for PLS or ALS in the last 30 days.
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I have some difficulty walking but can still walk.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had active cancer in the last 2 years, except for treated skin cancer.
Select...
I have received or will receive botulinum toxin in my legs within the last 6 months.
Select...
I am not pregnant, breastfeeding, or trying to conceive.
Select...
I do not have serious liver, kidney diseases, nerve issues, or certain genetic conditions.
Select...
I am allergic to pyridine or ingredients in dalfampridine tablets.
Select...
My kidney function is reduced with a creatinine clearance of ≤50 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over the course of study at weeks 2, 4, 6, 10, 14, 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of study at weeks 2, 4, 6, 10, 14, 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
consistent improvement in the Timed 25 Foot Walk test
Secondary study objectives
Effect of Dalfampridine on quality of life
Effects of Dalfampridine on functional status
Trial Design
1Treatment groups
Experimental Treatment
Group I: AmpyraExperimental Treatment1 Intervention
Ampyra open label
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dalfampridine
2013
Completed Phase 4
~90
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Motor Neuron Disease (MND) or Amyotrophic Lateral Sclerosis (ALS) include riluzole, edaravone, and sodium phenylbutyrate-taurursodiol. Riluzole works by inhibiting glutamate release, which helps reduce excitotoxicity, a process that damages neurons.
Edaravone acts as a free radical scavenger, reducing oxidative stress that contributes to neuronal damage. Sodium phenylbutyrate-taurursodiol combines two drugs that reduce neuronal cell death by targeting different cellular pathways.
These treatments are crucial as they aim to slow disease progression and improve quality of life. Dalfampridine, a potassium channel blocker, enhances signal conduction in damaged nerves, which may improve motor function.
Understanding these mechanisms helps tailor treatment plans to manage symptoms and potentially slow disease progression in ALS patients.
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,078 Previous Clinical Trials
1,137,775 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,354 Total Patients Enrolled
Dale Lange, MDPrincipal InvestigatorHSS
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had active cancer in the last 2 years, except for treated skin cancer.I have a condition affecting my brain's nerve cells, showing symptoms in at least 2 body areas.I have a history of seizures or any metal implants above the neck.I am willing and able to sign the informed consent.I am mentally capable of understanding and following the trial's procedures.I haven't taken any drugs for PLS or ALS in the last 30 days.I have some difficulty walking but can still walk.I have received or will receive botulinum toxin in my legs within the last 6 months.I am between 18 and 99 years old.I am not pregnant, breastfeeding, or trying to conceive.You have misused drugs or alcohol in the past year.I do not have serious liver, kidney diseases, nerve issues, or certain genetic conditions.I am allergic to pyridine or ingredients in dalfampridine tablets.I cannot become pregnant or am using effective birth control.You have not had an allergic reaction to dalfampridine before.My kidney function is reduced with a creatinine clearance of ≤50 mL/min.You must be able to breathe out a certain amount of air, at least 60% of what is expected for someone your age and size.Your lab test results show significant health problems.Your symptoms started more than 18 months ago.I haven't taken Riluzole in the last 30 days or am on a stable dose.You had a test within the last 3 months that shows little or no sign of a specific kind of nerve disease.
Research Study Groups:
This trial has the following groups:- Group 1: Ampyra
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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