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Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell Multiple Sclerosis (MS) Center

This study is currently recruiting participants.
Verified July 2011 by Mount Sinai Rehabilitation Hospital
Sponsor:
Collaborator:
Brown University
Information provided by:
Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01399957
First received: July 19, 2011
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

Ampyra (dalfampridine) has been recently approved by the FDA for improving walking speed in persons with multiple sclerosis. However, only 35%-45% of persons with multiple sclerosis who take the drug show and increase in walking speed. This project seeks (1) to determine factors that will predict a response (an increase in walking speed) to dalfampridine and (2) 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 are start taking the medication.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai Rehabilitation Hospital:

Primary Outcome Measures:
  • Change in 25ft walk time [ Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks ] [ Designated as safety issue: Yes ]
  • Change in 6 minute walk distance [ Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks ] [ Designated as safety issue: Yes ]
    Measure of endurance


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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.


Estimated Enrollment: 120
Study Start Date: August 2010
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
pwMS perscribed Ampyra

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399957

Contacts
Contact: Jennifer Ruiz, BS 860-714-2149
Contact: Michele Labas, BA 860-714-2149

Locations
United States, Connecticut
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital Recruiting
Hartford, Connecticut, United States, 06112
Contact: Jennifer Ruiz     860-714-2149        
Sponsors and Collaborators
Mount Sinai Rehabilitation Hospital
Brown University
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
  More Information

No publications provided

Responsible Party: Albert Lo, MD, PhD and Elizabeth Triche, PhD, Mount Sinai Rehabilitation Hospital, Brown University
ClinicalTrials.gov Identifier: NCT01399957     History of Changes
Other Study ID Numbers: AL0003
Study First Received: July 19, 2011
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai Rehabilitation Hospital:
Multiple Sclerosis
Ampyra
Dalfampridine

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

ClinicalTrials.gov processed this record on June 17, 2013