Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

NCT01399957 | Completed

• 1 other identifier: AL0003
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Dalfampridine-ER; Walking speed

Outcome Measures

Primary Outcomes (2)

• Change in 25ft walk time

  Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks

• Change in 6 minute walk distance

  Measure of endurance

  Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks

Secondary Outcomes (1)

• Change of Upper extremity dexterity with 9hole peg test

  Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with MS who have been prescribed ampyra at the Mandell Center for Multiple Sclerosis.

You may qualify if:

• 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)
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Rehabilitation Hospital: lead
• Brown University: collaborator
• Acorda Therapeutics: collaborator

Study Sites (1)

Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

Location

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.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Albert Lo, M.D, Ph.D.

  Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Elizabeth Triche, Ph.D

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 22, 2011
• Study Start: August 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

US (1)