Dalfampridine for Imbalance in Multiple Sclerosis

NCT ID: NCT01444300

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

Brief 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.

Conditions

Multiple Sclerosis; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dalfampridine

Group Type: EXPERIMENTAL

Dalfampridine

Intervention Type: DRUG

10mg, bid, pill taken by mouth for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo pill, bid for 12 weeks

Interventions

Dalfampridine

10mg, bid, pill taken by mouth for 12 weeks

Intervention Type: DRUG

Placebo

placebo pill, bid for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Ampyra

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Michelle Cameron

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Related Links

http://www.ohsu.edu/ms

OHSU Multiple Sclerosis Center

Other Identifiers

GNEUR0637A

Identifier Type: -

Identifier Source: org_study_id