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Potassium Channel Blocker
Dalfampridine + Physical Therapy for Multiple Sclerosis (AmpPT Trial)
Phase 4
Recruiting
Led By Prudence Plummer, PhD, PT
Research Sponsored by MGH Institute of Health Professions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Montreal Cognitive Assessment 23 or higher
Not currently taking dalfampridine or not previously taken and discontinued due to adverse reactions
Must not have
History of seizures
Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 6, week 8 to week 14
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial will study if combining MS medication with physical therapy is better than either treatment alone for improving walking.
Who is the study for?
This trial is for people with MS who can walk a bit but have trouble with mobility. They should be able to stand on their own and understand instructions, haven't had a relapse in 3 months, and aren't currently on dalfampridine or physical therapy. People with other conditions affecting movement, recent hospital stays, uncontrolled blood pressure or diabetes, history of seizures, kidney issues, or women who are pregnant can't join.
What is being tested?
Researchers are testing if taking the drug dalfampridine along with physical therapy helps improve walking more than just one treatment alone. Participants will first take the medication for six weeks then stop for two before starting a six-week physical therapy program where half will also resume the medication.
What are the potential side effects?
Dalfampridine may cause side effects like urinary tract infections, insomnia, dizziness, headache, nausea and potential risk of seizures. Physical therapy generally has minimal risks but could include muscle soreness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cognitive function is relatively good.
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I am not currently on dalfampridine and have never stopped it due to side effects.
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I can walk with assistance.
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I can walk 25 feet in 6 to 45 seconds.
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I can stand by myself for at least 10 seconds.
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I have been diagnosed with multiple sclerosis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures.
Select...
I have a condition affecting my movement or physical activity.
Select...
I have kidney problems.
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I have not been hospitalized in the last 3 months.
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I have high blood pressure or diabetes that is not well-managed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 to week 6, week 8 to week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 6, week 8 to week 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Timed 25-Foot Walk (T25FW)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
3Treatment groups
Active Control
Group I: Physical therapyActive Control1 Intervention
One-on-one outpatient physical therapy twice per week
Group II: Dalfampridine onlyActive Control1 Intervention
10 mg tablet twice per day
Group III: Dalfampridine plus physical therapyActive Control1 Intervention
10 mg tablet twice per day while receiving one-on-one outpatient physical therapy twice per week
Find a Location
Who is running the clinical trial?
MGH Institute of Health ProfessionsLead Sponsor
16 Previous Clinical Trials
2,232 Total Patients Enrolled
Prudence Plummer, PhD, PTPrincipal InvestigatorMGH Institute of Health Professions