Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399957
• Other study ID #: AL0003
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: November 9, 2015
• Start date: August 2010
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Mount Sinai Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital	Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Mount Sinai Rehabilitation Hospital	Acorda Therapeutics, Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 25ft walk time		Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks	Yes
Primary	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	Yes
Secondary	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	Yes