Dalfampridine for Imbalance in Multiple Sclerosis

NCT01444300 | Completed Phase 2 Results DMC

• 1 other identifier: GNEUR0637A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

multiple sclerosis; postural balance; gait; fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores

  Baseline to 12 weeks

• Change in Timed 25 Foot Walking Speed

  Baseline to 12 weeks

Study Arms (2)

Dalfampridine

EXPERIMENTAL

Drug: Dalfampridine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dalfampridine DRUG

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

Also known as: Ampyra

Dalfampridine

Placebo DRUG

placebo pill, bid for 12 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Acorda Therapeutics: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Links

• OHSU Multiple Sclerosis Center

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Michelle Cameron
• Organization: Oregon Health & Science University

cameromi@ohsu.edu

503-218-1971

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 30, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 16, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-05

Locations

US (1)