NCT02146534

Brief Summary

Phase 4, single center, double-blind, placebo-controlled study. Fifty (50) patients with MacDonald criteria (2005) multiple sclerosis will undergo active motor training as per the NeuroGym protocol, consisting of 3 sessions of 1 hour per week for a period of 6 weeks (total of 18 sessions). Half of the patients will be randomized to receive prolonged-release fampridine 10 mg BID as per label, and the other half will receive a placebo BID. All patients will continue to take their medication (fampridine or placebo) during a subsequent observational period of 8 weeks. Patients will be evaluated at times -4, 0, 6 and 14 weeks. Study Objectives: Primary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID will show greater benefit from active motor training as compared with subjects treated with placebo in terms of incidence of responders, degree of response, and duration of response. Secondary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID will show greater benefit from active motor training as compared with subjects treated with placebo in terms of quality of life measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4 multiple-sclerosis

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

April 23, 2014

Last Update Submit

March 4, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • change in mobility

    timed 8 minutes walk (T8MW) 6 minutes walk (6MW) five times sit to stand test (FTSST)

    over 6 and 14 weeks

Secondary Outcomes (1)

  • change in quality of life

    over 6 and 14 weeks

Study Arms (2)

fampridine

EXPERIMENTAL

extended release fampridine 10mg BID PO for 14 weeks

Drug: extended release fampridine

placebo

PLACEBO COMPARATOR

placebo pill BID PO for 14 weeks

Drug: Placebo

Interventions

extended release fampridineDRUG

pts will receive Fampyra 10 mg BID PO for the duration of the study

Also known as: Fampyra
fampridine
PlaceboDRUG

placebo will be taken PO BID

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of McDonald criteria MS of all types and of age 18 and older.
  • Subjects who meet the prescribing criteria for Fampyra as per product monograph.
  • Therapeutic stability (MS and symptomatic treatment) for 3 months prior to screening and for the duration of the study.
  • Pyramidal system functional assessment score of 2 or greater and the ability to complete all the assessments with or without aids.
  • Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

You may not qualify if:

  • Any contraindication to receiving fampridine as per product monograph including but not limited to prior history of epilepsy, renal dysfunction (abnormal serum creatinine), concomitant treatment with cimetidine or quinidine.
  • Ongoing treatment with fampridine or prior history of fampridine intolerance or ineffectiveness
  • Any other condition that would preclude them from undergoing the NeuroGym training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Neuro-Outaouais

Gatineau, Quebec, J9J 0A5, Canada

Location

Related Publications (1)

  • Jacques F, Schembri A, Nativ A, Paquette C, Kalinowski P. Prolonged-Release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: A Pilot, Double-Blind, Randomized, Placebo-Controlled Study. Mult Scler J Exp Transl Clin. 2018 Mar 9;4(1):2055217318761168. doi: 10.1177/2055217318761168. eCollection 2018 Jan-Mar.

    PMID: 29552356DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Francois H Jacques, MD FRCP

    Clinique Neuro-Outaouais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 26, 2014

Study Start

December 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

CA(1)