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Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT01399957
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : November 10, 2015
Sponsor:
Collaborators:
Brown University
Acorda Therapeutics
Information provided by (Responsible Party):
Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital

Brief 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. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.

Condition or disease
Multiple Sclerosis

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 Type : Observational
Actual Enrollment : 52 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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
Study Start Date : August 2010
Primary Completion Date : September 2014
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Change in 25ft walk time [ Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks ]
  2. 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


Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
15 mL of blood will be collected into an EDTA tube from participants at assessment appointments. Both serum and cells will be frozen and stored in a -80 degree freezer.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons with MS who have been prescribed ampyra at the Mandell Center for Multiple Sclerosis.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399957


Locations
United States, Connecticut
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, United States, 06112
Sponsors and Collaborators
Mount Sinai Rehabilitation Hospital
Brown University
Acorda Therapeutics
Investigators
Principal Investigator: Albert Lo, M.D, Ph.D. Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Principal Investigator: Elizabeth Triche, Ph.D Brown University

Responsible Party: Jennifer Ruiz, DPT, Research Manager, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01399957     History of Changes
Other Study ID Numbers: AL0003
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital:
Multiple Sclerosis
Dalfampridine-ER
Walking speed

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action