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New treatment option for Multiple Sclerosis
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]?
Dalfampridine 10 MG [Ampyra] is an investigational medicine, being studied as a potential treatment for multiple sclerosis.
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
- The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are: Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine?
- 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's taking place
- 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 - 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?
Study sites include Boston, Massachusetts, United States. 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.