Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters. A cross-over, double-blinded, placebo-controlled study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005076-34-BE

Enrollment

110

Registered

2012-12-14

Start date

2013-01-03

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Interventions

Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 Pharmaceutical Form: Prolonged-release tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, candidates must meet the following eligibility criteria: 1.aged > 18 years and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Candidates will be excluded from study entry if any of the following exclusion criteria are met at the screening visit or at any time during the screening period: 1. Presence of gait or walking disability not attributed to MS 2. EDSS score > 6.0 3. Relapse or steroid treatment within the last 4 weeks before inclusion 4. Any history of seizure, epilepsy or other convulsive disorder with the exception of febrile seizures in childhood. 5. Mild, moderate or severe renal impairment 6. Contraindication to Motor Evoked Potentials 7. Incapacity to walk on a treadmill at a comfortable speed during at least 3 minutes 8. Concurrent treatment with other medicinal products containing 4-aminopyridine 9. Concomitant use of medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine. 10. Breastfeeding or pregnant female subjects or subjects who are considering becoming pregnant.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess the effect of treatment with prolonged-release fampridine 10 mg twice, on the quantified gait analysis parameters (kinematics, dynamics, mechanical work).;Secondary Objective: The secondary objectives of this study are the followings: -quantified gait analysis by electromyographic activity and energy cost -clinical efficacy on strength, spasticity, walking tests, subjective self assessed walking functional parameters, quality of life, and fatigue -amplitude and latency of motor evoked potentials;Primary end point(s): Change from baseline in the quantified gait analysis kinematic, dynamic and mechanical work parameters;Timepoint(s) of evaluation of this end point: Each patient will be randomized, after inclusion, in group 1 or 2. Group 1 will receive the treatment during 6 weeks, then have a period of 2 weeks of wash-out, and after this be treated with placebo for 6 weeks. Group 2 will receive the placebo first for 6 weeks, be washed-out for 2 weeks, and then have the IMP for 6 weeks. Each patient will thus be evaluated 4 times, before and at the end of each period of treatment.	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess the effect of treatment with prolonged-release fampridine 10 mg twice, on the quantified gait analysis parameters (kinematics, dynamics, mechanical work).;Secondary Objective: The secondary objectives of this study are the followings: -quantified gait analysis by electromyographic activity and energy cost -clinical efficacy on strength, spasticity, walking tests, subjective self assessed walking functional parameters, quality of life, and fatigue -amplitude and latency of motor evoked potentials;Primary end point(s): Change from baseline in the quantified gait analysis kinematic, dynamic and mechanical work parameters;Timepoint(s) of evaluation of this end point: Each patient will be randomized, after inclusion, in group 1 or 2. Group 1 will receive the treatment during 6 weeks, then have a period of 2 weeks of wash-out, and after this be treated with placebo for 6 weeks. Group 2 will receive the placebo first for 6 weeks, be washed-out for 2 weeks, and then have the IMP for 6 weeks. Each patient will thus be evaluated 4 times, before and at the end of each period of treatment.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Each patient will thus be evaluated 4 times, before and at the end of each period of treatment. These evaluations will be coupled with the primary endpoint evaluations.;Secondary end point(s): -comparison of change after treatment, of quantified parameters of electromyography and energy cost an gait analysis -comparison of clinical parameters (spasticity, strength, muscular stiffness, walking tests) and subjectives scores (MSWS-12, Borg scale, quality of life, fatigue) -comparison of motor evoked potentials parameters	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Each patient will thus be evaluated 4 times, before and at the end of each period of treatment. These evaluations will be coupled with the primary endpoint evaluations.;Secondary end point(s): -comparison of change after treatment, of quantified parameters of electromyography and energy cost an gait analysis -comparison of clinical parameters (spasticity, strength, muscular stiffness, walking tests) and subjectives scores (MSWS-12, Borg scale, quality of life, fatigue) -comparison of motor evoked potentials parameters

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Countries

Belgium

Contacts

Public ContactSouraya ElSankari

Cliniques Universitaires Saint-Luc, Neurologie

souraya.elsankari@uclouvain.be003227641932

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026