Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brown University
Acorda Therapeutics
Information provided by (Responsible Party):
Jennifer Fawcett, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01399957
First received: July 19, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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
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:


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.


Enrollment: 52
Study Start Date: August 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jennifer Fawcett, Research Manager, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01399957     History of Changes
Other Study ID Numbers: AL0003
Study First Received: July 19, 2011
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014