Multiple SclerosisPhase 4NCT02146534
Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients
A Phase 4 study testing extended release fampridine in people with Multiple Sclerosis, run by Clinique Neuro-Outaouais at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- extended release fampridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study.
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.
Read more
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.
Read the detailed description
Rationale for the study
Prolonged-release fampridine (4-aminopyridine) is a voltage-gated potassium channel blocking agent. It relieves conduction block in demyelinated nerve fibers by blocking voltage-gated potassium channels on the paranodal axon membranes in vitro. It enhances synaptic transmission by blocking repolarizing potassium currents thus increasing the size of the presynaptic action potential and thus increasing transmitter release. It has been shown in multiple sclerosis patients to improve walking capabilities as measured by the timed 25 feet walk test by more than 20% in approximately 34% of subjects. Prolonged-release fampridine also has measurable effects on motor evoked potentials with transcranial magnetic stimulation in patients with multiple sclerosis and partial spinal cord injuries.
The brain is a dynamic plastic organ that continuously adapts to the demands made upon it. Prolonged-release fampridine by improving nerve conduction in multiple sclerosis patients has the potential to enhance brain plasticity. Activities or processes that call upon such plasticity could therefore also benefit from prolonged-release fampridine. Active motor training when combined with prolonged-release fampridine in patients with multiple sclerosis could therefore show a larger and more sustained measurable clinical benefit than with active motor training alone.
Prolonged-release fampridine by enhancing brain plasticity through improved nerve conduction in the central nervous system can potentiate the clinical benefits of active motor training as measured via assessments of walking capabilities and quality of life in subjects with multiple sclerosis of varying severity.
- Conditions
- Multiple Sclerosis
- Being tested
- extended release fampridine, Placebo
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended release fampridineDrug
Also called Fampyra
pts will receive Fampyra 10 mg BID PO for the duration of the study
PlaceboDrug
placebo will be taken PO BID
| Study group | Role | What they receive |
|---|---|---|
| fampridine | Experimental | extended release fampridine 10mg BID PO for 14 weeks Receives: Drug: extended release fampridine |
| placebo | Placebo comparator | placebo pill BID PO for 14 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mobility
timed 8 minutes walk (T8MW) 6 minutes walk (6MW) five times sit to stand test (FTSST)
Measured: over 6 and 14 weeks
Secondary outcomes (1)
change in quality of life
multiple sclerosis impact scale (MSIS-29) short form health survey (SF-36)
Measured: over 6 and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Neuro-Outaouais
- Sponsor type
- University, hospital or other
- Collaborators
- CogState Ltd.
- Responsible party
- Sponsor
- Investigators
- Francois H Jacques, MD FRCP, Principal investigator, Clinique Neuro-Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146534
- Sponsor's protocol ID
- CAN-FMP-13-10507
- Status last verified
- Mar 2019
- First submitted
- 23 Apr 2014
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29552356
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT02146534
- Acronym / sponsor ID
- CAN-FMP-13-10507
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Clinique Neuro-OutaouaisUniversity, hospital or other
- Collaborators
- CogState Ltd.
- Study start
- Dec 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale for the study
Prolonged-release fampridine (4-aminopyridine) is a voltage-gated potassium channel blocking agent. It relieves conduction block in demyelinated nerve fibers by blocking voltage-gated potassium channels on the paranodal axon membranes in vitro. It enhances synaptic transmission by blocking repolarizing potassium currents thus increasing the size of the presynaptic action potential and thus increasing transmitter release. It has been shown in multiple sclerosis patients to improve walking capabilities as measured by the timed 25 feet walk test by more than 20% in approximately 34% of subjects. Prolonged-release fampridine also has measurable effects on motor evoked potentials with transcranial magnetic stimulation in patients with multiple sclerosis and partial spinal cord injuries.
The brain is a dynamic plastic organ that continuously adapts to the demands made upon it. Prolonged-release fampridine by improving nerve conduction in multiple sclerosis patients has the potential to enhance brain plasticity. Activities or processes that call upon such plasticity could therefore also benefit from prolonged-release fampridine. Active motor training when combined with prolonged-release fampridine in patients with multiple sclerosis could therefore show a larger and more sustained measurable clinical benefit than with active motor training alone.
Prolonged-release fampridine by enhancing brain plasticity through improved nerve conduction in the central nervous system can potentiate the clinical benefits of active motor training as measured via assessments of walking capabilities and quality of life in subjects with multiple sclerosis of varying severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fampridine | Experimental | Drug: extended release fampridineextended release fampridine 10mg BID PO for 14 weeks |
| placebo | Placebo comparator | Drug: Placeboplacebo pill BID PO for 14 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended release fampridineAlso: Fampyrapts will receive Fampyra 10 mg BID PO for the duration of the study | Drug | fampridine |
| Placeboplacebo will be taken PO BID | Drug | placebo |
Primary outcome
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)
1 secondary outcome
change in quality of life
Time frame: over 6 and 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Derived from this study: PubMed 29552356Jacques 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois H Jacques, MD FRCP principal investigator
Clinique Neuro-Outaouais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing extended release fampridine in people with Multiple Sclerosis, run by Clinique Neuro-Outaouais at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mobility (time frame: over 6 and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02146534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.