NCT02146534

Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study.

Completed Phase 4 Last updated 4 March 2019

What this trial tests

Phase 4 trial testing extended release fampridine in Multiple Sclerosis in 44 participants. Completed in 1 January 2016.

Timeline

1 December 2013

Primary endpoint
1 January 2016

1 January 2016

Quick facts

Lead sponsor	Clinique Neuro-Outaouais
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	44
Start date	1 December 2013
Primary completion	1 January 2016
Estimated completion	1 January 2016
Sites	1 location across Canada

Drugs / interventions tested

• extended release fampridine
• Placebo

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Clinique Neuro-Outaouais — full company profile →

Who can join

18 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• change in mobility
  Time frame: over 6 and 14 weeks
  timed 8 minutes walk (T8MW) 6 minutes walk (6MW) five times sit to stand test (FTSST)

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prolonged-Release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: A Pilot, Double-Blind, Randomized, Placebo-Controlled Study.
   Jacques F, Schembri A, Nativ A, Paquette C, et al · · 2018 · cited 4× · PMID 29552356 · DOI 10.1177/2055217318761168