NCT02143167: RETRAP

RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis

Completed Phase 4 Last updated 22 August 2018

What this trial tests

Phase 4 trial testing SR-fampridine in Multiple Sclerosis in 40 participants. Completed in 1 January 2015.

Timeline

1 May 2014

Primary endpoint
1 January 2015

1 January 2015

Quick facts

Lead sponsor	University of Southern Denmark
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	1 May 2014
Primary completion	1 January 2015
Estimated completion	1 January 2015
Sites	4 locations across Denmark

Drugs / interventions tested

• SR-fampridine — full drug profile →
• Placebo

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

University of Southern Denmark

Who can join

Adults 18 to 60, 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.

• Muscle power in the lower limbs
  Time frame: Muscle power will be measured after 14 weeks of resistance training.
  Muscle power in the lower limbs is measured by dynamometry pre and post resistance training

Sponsor's own description

Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately 40% of MS patients suffering from this by overcoming partly or total conduction block due to demyelination.

Resistance training has been shown to provide the same kind of benefits for patients by targeting the muscular component of the motor unit. Thus by combining the two it is likely to see an synergistic effect.

This trial is designed as a double blind, randomized placebo controlled trial with subsequent cross-over.

Participants in the two arms will go through the same progressive training program targets at the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives placebo. in the the end there is another four weeks of training after cross-over has been performed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.