Status:

COMPLETED

Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Lead Sponsor:

Mount Sinai Rehabilitation Hospital

Collaborating Sponsors:

Brown University

Acorda Therapeutics

Conditions:

Multiple Sclerosis

Eligibility:

All Genders

18+ years

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 dalfampri...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2015

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT01399957

Start Date

August 1 2010

End Date

September 1 2015

Last Update

November 10 2015

Active Locations (1)

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Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, United States, 06112