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Dalfampridine for Imbalance in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Michelle Cameron, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01444300
First received: September 20, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Fatigue
Drug: Dalfampridine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Change in Automatic Postural Response (APR )Latency [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Timed 25 Foot Walking Speed [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dalfampridine Drug: Dalfampridine
10mg, bid, pill taken by mouth for 12 weeks
Other Name: Ampyra
Placebo Comparator: Placebo Drug: Placebo
placebo pill, bid for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444300

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Acorda Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Michelle Cameron, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01444300     History of Changes
Other Study ID Numbers: GNEUR0637A
Study First Received: September 20, 2011
Results First Received: January 13, 2014
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
multiple sclerosis
postural balance
gait
fatigue

Additional relevant MeSH terms:
Fatigue
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
4-Aminopyridine
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Potassium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014