Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients?

NCT01667497 | Completed Phase 2

• 1 other identifier: 102825
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Fatigue

Keywords

Cognitive fatigue; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Paced Auditory Serial Addition Test (PASAT) Cognitive Fatigue scores

  Measure of cognitive fatigue

  Day 1, day 29 and Day 37, Day 64

Study Arms (2)

Fampridine SR

EXPERIMENTAL

Fampridine SR 10mg BID

Drug: Fampridine SR

Placebo

PLACEBO COMPARATOR

non-drug

Drug: Placebo

Interventions

Fampridine SR DRUG

Fampridine SR

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)

London, Ontario, N6G 1W8, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 17, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

CA (1)