Multiple SclerosisPhase 2/3NCT05859802
Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis
A Phase 2/3 study testing Dalfampridine Pill in people with Multiple Sclerosis, run by D'Youville College.
Trial summary
The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dalfampridine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2011to 9 Jan 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 years or older confirmed MS diagnosis
- Expanded Disability Status Scale (EDSS) of 7.0 or higher
- No steroid treatment in the last 30 days or a relapse in the last 90 days, and MS considered stable
- Capable of performing requirements of Physical Therapy (PT) treatment including at least a 2/5 manual muscle test in 50% or more of the major muscle groups
Who cannot join
- History of seizure disorder
- Major cognitive or mental illness that prevented their ability to provide consent
- Evidence of other medical cause of cognitive impairment besides MS
- Severe joint contractures that limited the patients ability to move within full active range of motion
About this study
Official title: Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis
The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are:
- Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone
- Does Physical Therapy improve functional outcomes in patients who are non ambulatory
Read the detailed description
This randomized control trial examined the effectiveness of dalfampridine when administered in conjunction with 12 weeks of physical therapy compared to physical therapy and a placebo on function, quality of life (QoL) and cognition in non-ambulatory pwMS.
Specific Aim 1: Assess the change in standing tolerance, transfers, repeated sit to stand, QoL and cognitive processing for non-ambulatory individuals with MS between subjects on Dalfampridine who receive physical therapy and those who participate in physical therapy and receive a placebo. Enhancing the propagation of action potentials along axons in addition to regularly contracting the muscles through exercise may have a greater effect on strength and functional mobility.
Specific Aim 2: Assess the functional, strength and cognitive changes within all subjects receiving PT 2x a week for 12 weeks. Evidence supporting the effectiveness of physical therapy in this population is extremely limited.
- Conditions
- Multiple Sclerosis
- Being tested
- Dalfampridine Pill, Placebo
- Keywords
- Dalfampridine, Functional Mobility, Non ambulatory, Cognition, Quality of Life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalfampridine PillDrug
Also called Physical Therapy
Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking dalfampridine 10 mg two times day
PlaceboDrug
Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking a placebo pill two times day
| Study group | Role | What they receive |
|---|---|---|
| Drug Group | Experimental | Not described Receives: Drug: Dalfampridine Pill |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSQOL -54
Measured: Baseline
MSQOL -54
Measured: 6 weeks
MSQOL -54
Measured: 12 weeks
Five time Sit to Stand
Measured: Baseline
Five time Sit to Stand
Measured: 6 weeks
Five time Sit to Stand
Measured: 12 weeks
Secondary outcomes (12)
Symbol Digit Modalities Test
Measured: Baseline
Symbol Digit Modalities Test
Measured: 6 weeks
Symbol Digit Modalities Test
Measured: 12 weeks
Wheel chair to Mat transfers - Functional Independence Measure
Measured: Baseline
Wheel chair to Mat transfers - Functional Independence Measure
Measured: 6 weeks
Wheel chair to Mat transfers - Functional Independence Measure
Measured: 12 weeks
Standing Tolerance
Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded.
Measured: Baseline
Standing Tolerance
Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded.
Measured: 6 weeks
Standing Tolerance
Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded.
Measured: 12 weeks
9 Hole Peg Test
Measured: Baseline
9 Hole Peg Test
Measured: 6 weeks
9 Hole Peg Test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start13 Jul 2011
- Primary completion3 Mar 2015
- Study completion9 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Youville College
- Sponsor type
- University, hospital or other
- Collaborators
- Acorda Therapeutics, University at Buffalo
- Responsible party
- Principal investigator, Lacey Bromley, D'Youville College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859802
- Sponsor's protocol ID
- RMD0690511A
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05859802
- Acronym / sponsor ID
- RMD0690511A
- Conditions
- Multiple Sclerosis
- Keywords
- Dalfampridine, Functional Mobility, Non ambulatory, Cognition, Quality of Life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- D'Youville CollegeUniversity, hospital or other
- Collaborators
- Acorda Therapeutics, University at Buffalo
- Study start
- 13 Jul 2011 (actual)
- Primary completion
- 3 Mar 2015 (actual)
- Study completion
- 9 Jan 2016 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are:
- Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone
- Does Physical Therapy improve functional outcomes in patients who are non ambulatory
Detailed description
This randomized control trial examined the effectiveness of dalfampridine when administered in conjunction with 12 weeks of physical therapy compared to physical therapy and a placebo on function, quality of life (QoL) and cognition in non-ambulatory pwMS.
Specific Aim 1: Assess the change in standing tolerance, transfers, repeated sit to stand, QoL and cognitive processing for non-ambulatory individuals with MS between subjects on Dalfampridine who receive physical therapy and those who participate in physical therapy and receive a placebo. Enhancing the propagation of action potentials along axons in addition to regularly contracting the muscles through exercise may have a greater effect on strength and functional mobility.
Specific Aim 2: Assess the functional, strength and cognitive changes within all subjects receiving PT 2x a week for 12 weeks. Evidence supporting the effectiveness of physical therapy in this population is extremely limited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Group | Experimental | Drug: Dalfampridine Pill |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 years or older confirmed MS diagnosis
- Expanded Disability Status Scale (EDSS) of 7.0 or higher
- No steroid treatment in the last 30 days or a relapse in the last 90 days, and MS considered stable
- Capable of performing requirements of Physical Therapy (PT) treatment including at least a 2/5 manual muscle test in 50% or more of the major muscle groups
Key exclusion criteria (4 listed)
- History of seizure disorder
- Major cognitive or mental illness that prevented their ability to provide consent
- Evidence of other medical cause of cognitive impairment besides MS
- Severe joint contractures that limited the patients ability to move within full active range of motion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalfampridine PillAlso: Physical TherapySubjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking dalfampridine 10 mg two times day | Drug | Drug Group |
| PlaceboSubjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking a placebo pill two times day | Drug | Placebo Group |
Primary outcome
MSQOL -54
Time frame: Baseline
MSQOL -54
Time frame: 6 weeks
MSQOL -54
Time frame: 12 weeks
Five time Sit to Stand
Time frame: Baseline
Five time Sit to Stand
Time frame: 6 weeks
Five time Sit to Stand
Time frame: 12 weeks
12 secondary outcomes
Symbol Digit Modalities Test
Time frame: Baseline
Symbol Digit Modalities Test
Time frame: 6 weeks
Symbol Digit Modalities Test
Time frame: 12 weeks
Wheel chair to Mat transfers - Functional Independence Measure
Time frame: Baseline
Wheel chair to Mat transfers - Functional Independence Measure
Time frame: 6 weeks
Wheel chair to Mat transfers - Functional Independence Measure
Time frame: 12 weeks
Standing Tolerance
Time frame: Baseline
Standing Tolerance
Time frame: 6 weeks
Standing Tolerance
Time frame: 12 weeks
9 Hole Peg Test
Time frame: Baseline
9 Hole Peg Test
Time frame: 6 weeks
9 Hole Peg Test
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dalfampridine Pill in people with Multiple Sclerosis, run by D'Youville College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSQOL -54 (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.