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Completed

NCT Number: NCT01399957

Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mount Sinai Rehabilitation Hospital

Other

Collaborators

  • Acorda Therapeutics
  • Brown University

Registry information

Official study title

Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jul 22, 2011
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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