Multiple SclerosisNCT01399957
Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital at 1 site in United States.
Trial summary
Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with MS who have been prescribed ampyra at the Mandell Center for Multiple Sclerosis.
Who may be able to join
- Confirmed clinical diagnosis of MS by McDonald criteria
- Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit
- Receive MS care at the Mandell MS center
- Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)
- 18 years of age or older
Who cannot join
- Already began to take drug prior to baseline research visit
- Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy
- Unwilling or unable to complete assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112
About this study
Official title: Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes
Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.
Read the detailed description
Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Dalfampridine-ER, Walking speed
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pwMS prescribed dalfampridine-ER | Anyone prescribed D-ER per usual clinical care was recruited into this observational study. All those willing to participate were consented and observed pre-drug and for a 14week period with two follow-up visits scheduled at 12 and 18months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 25ft walk time
Measured: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Change in 6 minute walk distance
Measure of endurance
Measured: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Secondary outcomes (1)
Change of Upper extremity dexterity with 9hole peg test
Measured: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionSep 2014
- Study completionSep 2015
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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Acorda Therapeutics
- Responsible party
- Principal investigator, Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital
- Investigators
- Albert Lo, M.D, Ph.D., Principal investigator, Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation HospitalElizabeth Triche, Ph.D, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399957
- Sponsor's protocol ID
- AL0003
- Status last verified
- Nov 2015
- First submitted
- 19 Jul 2011
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes
- ClinicalTrials.gov ID
- NCT01399957
- Acronym / sponsor ID
- AL0003
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Dalfampridine-ER, Walking speed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mount Sinai Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Brown University, Acorda Therapeutics
- Study start
- Aug 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jul 2011 (estimated)
- 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.
Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.
Detailed description
Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pwMS prescribed dalfampridine-ER | – | –Anyone prescribed D-ER per usual clinical care was recruited into this observational study. All those willing to participate were consented and observed pre-drug and for a 14week period with two follow-up visits scheduled at 12 and 18months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with MS who have been prescribed ampyra at the Mandell Center for Multiple Sclerosis.
Key inclusion criteria (5 listed)
- Confirmed clinical diagnosis of MS by McDonald criteria
- Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit
- Receive MS care at the Mandell MS center
- Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)
- 18 years of age or older
Key exclusion criteria (3 listed)
- Already began to take drug prior to baseline research visit
- Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy
- Unwilling or unable to complete assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in 25ft walk time
Time frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Change in 6 minute walk distance
Time frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Measure of endurance
1 secondary outcome
Change of Upper extremity dexterity with 9hole peg test
Time frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
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 10 Nov 2015.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Albert Lo, M.D, Ph.D. principal investigator
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Elizabeth Triche, Ph.D principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital at 1 site in United States.
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 5 inclusion and 3 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in 25ft walk time (time frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks). The study lists 2 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 10 Nov 2015.