Dalfampridine for ALS

Palo Alto (17 mi)

Overseen byDale Lange, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I haven't taken any drugs for PLS or ALS in the last 30 days.

I have some difficulty walking but can still walk.

Exclusion Criteria

I have had active cancer in the last 2 years, except for treated skin cancer.

I have received or will receive botulinum toxin in my legs within the last 6 months.

I am not pregnant, breastfeeding, or trying to conceive.

I do not have serious liver, kidney diseases, nerve issues, or certain genetic conditions.

I am allergic to pyridine or ingredients in dalfampridine tablets.

My kidney function is reduced with a creatinine clearance of ≤50 mL/min.

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: AmpyraExperimental Treatment1 Intervention

Ampyra open label

Dalfampridine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Ampyra for: