Multiple Sclerosis study: Dalfampridine
Official title Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
ClinicalTrials.gov ID: NCT06136728
What this study is testing
What is Dalfampridine 10 MG [Ampyra]?
This is an investigational oral medication being studied to see if it helps improve walking in people with multiple sclerosis. It is designed to help nerve signals travel more smoothly in the spinal cord.
Also referred to as Ampyra.
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
- This study aims to find out if combining a medication called dalfampridine with physical therapy improves walking more than using either treatment alone.
- Who it's for
- People with multiple sclerosis who have trouble walking or moving.
- What's involved
- Participants will take dalfampridine for 6 weeks, stop for 2 weeks, and then join a 6-week physical therapy program. Some will restart the medication during therapy, while others will not.
- Time commitment
- The study lasts about 4 months, including a final check-up to see if the benefits last.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 75
You may be able to join if
- Confirmed diagnosis of MS
- Expanded Disability Status Scale (EDSS) 6.5 or less
- Timed 25-Foot Walk 6-45 seconds (average of 2 trials)
- Able to stand unsupported for at least 10 seconds
- Montreal Cognitive Assessment 23 or higher
You likely can't join if
- Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity
- Unable to follow a 3-step verbal command in English
- Hospitalization for any reason in the last 3 months
- Uncontrolled hypertension or diabetes
- History of seizures
- Renal impairment
See the full eligibility criteria
- Confirmed diagnosis of MS
- Expanded Disability Status Scale (EDSS) 6.5 or less
- Timed 25-Foot Walk 6-45 seconds (average of 2 trials)
- Able to stand unsupported for at least 10 seconds
- Montreal Cognitive Assessment 23 or higher
- Relapse free for at least 3 months
- Not currently taking dalfampridine or not previously taken and discontinued due to adverse reactions
- Not currently receiving physical therapy
- Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity
- Unable to follow a 3-step verbal command in English
- Hospitalization for any reason in the last 3 months
- Uncontrolled hypertension or diabetes
- History of seizures
- Renal impairment
- Women who are breastfeeding, pregnant, or trying to become pregnant
- Contraindications to magnetic resonance imaging (MRI; to be excluded from MRI procedures but may participate if all other criteria are met)
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
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, 25 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. 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.