Dalfampridine for Imbalance in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444300
• Other study ID #: GNEUR0637A
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: May 16, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 59 Years

Eligibility

Inclusion Criteria:

• Age 20- 59 years,

• Able to walk at least 100m without an aide or with unilateral assistance

• Prolonged APR latencies (= 1SD > mean for healthy people in this age range) OR,

• Reduced balance-related activity (ABC scores = 85%),

• Abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning duration, cadence, double support time, stride length or gait cycle time (outside 1SD of the average for healthy people in this age range)

Exclusion Criteria:

• Currently taking dalfampridine (any within the last 2 weeks),

• Cause(s) of imbalance other than MS,

• Impaired renal function (creatinine clearance =50mL/min),

• Seizure disorder

• Pregnancy or breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Dalfampridine
10mg, bid, pill taken by mouth for 12 weeks
• Placebo
placebo pill, bid for 12 weeks

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Automatic Postural Response (APR )Latency	Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of ~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects.	Baseline to 12 weeks	No
Secondary	Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores	The ABC is an 11-point scale and subjects are asked to indicate personal level of confidence in doing specific activities without losing balance or becoming unsteady on a scale from 0% to 100%. The ratings are added (possible range =0 -1600) and divide by 16 to get each subject's ABC score. A high ABC score indicates a high degree of confidence and a low ABC score indicates a low degree of confidence.	Baseline to 12 weeks	No
Secondary	Change in Timed 25 Foot Walking Speed		Baseline to 12 weeks	No