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Dalfampridine for Imbalance in Multiple Sclerosis

This study is ongoing, but not recruiting participants.
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: March 25, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in Automatic postural response (APR) latency [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
    APR latencies will be measured by Computerized Dynamic Posturography (CDP)

  • Change in Automatic postural response (APR)latency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    APR latencies will be measure by Computerized Dynamic Posturography (CDP)

  • Change in Automatic postural response (APR)latency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    APR latencies will be measure by Computerized Dynamic Posturography (CDP)


Secondary Outcome Measures:
  • Change in Activities-specific Balance Confidence (ABC) Questionnaire scores [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
  • Change in Community Integration Questionnaire (CIQ) scores [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
  • Change in static and dynamic balance [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
    Body-worn motion sensors (Gait-lab) will detect responses to dalfampridine.

  • Change in Modified Fatigue Impact Scale (MFIS) and Pittsburgh Quality Sleep Index (PSQI) scores [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
  • Change in Hearing Handicap Inventory for Adults (HHIA) scores [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
  • Change in Activities-specific Balance Confidence (ABC) Questionnaire scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Activities-specific Balance Confidence (ABC) Questionnaire scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Community Integration Questionnaire (CIQ) scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Community Integration Questionnaire (CIQ) scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in static and dynamic balance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Body-worn motion sensors (Gait-lab) will detect responses to dalfampridine.

  • Change in static and dynamic balance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body-worn motion sensors (Gait-lab) will detect responses to dalfampridine.

  • Change in Modified Fatigue Impact Scale (MFIS) and Pittsburgh Quality Sleep Index (PSQI) scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Modified Fatigue Impact Scale (MFIS) and Pittsburgh Quality Sleep Index (PSQI) scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Hearing Handicap Inventory for Adults (HHIA) scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Hearing Handicap Inventory for Adults (HHIA) scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 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
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:
OHSU Multiple Sclerosis Center  This link exits the ClinicalTrials.gov site

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
Last Updated: March 25, 2013
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
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013