Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients?

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by London Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Sarah Morrow, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01667497
First received: August 13, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

Multiple Sclerosis (MS) patients often complain of cognitive fatigue. There is currently no treatment for this symptom. Fampridine SR is a recently approved medication that improves walking ability and walking speed in MS patients. It is thought that it might have the same positive effect on cognitive fatigue. This study will compare fampridine 10mg twice a day to placebo in order to determine if there is any benefit of this medication for cognitive fatigue in MS.


Condition Intervention Phase
Cognitive Fatigue
Drug: Fampridine SR
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? A Cross Over Study

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • Change in Paced Auditory Serial Addition Test (PASAT) scores [ Time Frame: Day 1, day 29 and Day 37, Day 64 ] [ Designated as safety issue: No ]
    Measure of processing speed


Secondary Outcome Measures:
  • Change on Symbol Digit Modalities Test (SDMT) Score [ Time Frame: Day 1, day 29 and Day 37, Day 64 ] [ Designated as safety issue: No ]
    Measure of processing speed

  • Change on Stroop Colour Word Test [ Time Frame: Day 1, day 29 and Day 37, Day 64 ] [ Designated as safety issue: No ]
    measure of selective attention


Estimated Enrollment: 58
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fampridine SR
Fampridine SR 10mg BID
Drug: Fampridine SR
Placebo Comparator: Placebo Drug: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males/Females who are ≥ 18 years old and < 65 years old
  • Capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education
  • Have a diagnosis of Relapsing Remitting, Secondary Progressive or Primary Progressive MS, as per revised McDonald's Criteria
  • Have not received steroids in last thirty (30) days or a relapse in the last sixty (60) days, and whose MS is considered stable
  • Have a PASAT CF z-score that is worse than 1.5 SD below the mean (<-1.5 SD).
  • Have an Expanded Disability Status Scale (EDSS) of ≤ 7.0
  • Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care
  • Are capable of performing the requirements of a NP test battery including at least 20/70 near visual acuity by near vision chart, with correction allowed
  • If female, must neither be pregnant nor breast-feeding

Exclusion Criteria:

  • Have cognitive deficits caused by concomitant medication usage or other significant neurological/psychological disease e.g. Alzheimer's disease, Parkinson's disease, stroke, transient ischemic attack, Vascular Dementia, Huntington's disease, traumatic brain injury or chronic CNS infection
  • Have evidence of other medical cause(s) of cognitive impairment
  • Have evidence of major depression as determined by a positive BDIFS and clinician interview
  • Have a history of uncontrolled hypertension, tachycardia or cardiovascular or disease
  • Have a history or current presentation of seizure
  • Are currently taking compounded 4-aminopyridine or another form of fampridine
  • Have a known hypersensitivity to any medical or non-medical ingredient of the medication tablet.
  • Have evidence of renal impairment (creatinine clearance ≤ 80 mL/min)
  • Are taking medications that are inhibitors of the renal organic cation transporter 2 (OCT2)
  • Have a diagnosis of colour blindness
  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: NCT01667497

Locations
Canada, Ontario
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood) Not yet recruiting
London, Ontario, Canada, N6G 1W8
Contact: Heather Rosehart, BScH    519 685 8500 ext 34706    heather.rosehart@lhsc.on.ca   
Principal Investigator: Sarah A Morrow, MD, MS, FRCPC         
Sponsors and Collaborators
London Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sarah Morrow, Assistant Professor of Neurology, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01667497     History of Changes
Other Study ID Numbers: 102825
Study First Received: August 13, 2012
Last Updated: August 16, 2012
Health Authority: Canada: Health Canada

Keywords provided by London Health Sciences Centre:
Cognitive fatigue
multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
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 October 19, 2014