Multiple Sclerosis, Remittent ProgressivePhase 3MOTION - JAPANNCT01917019
A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis
A Phase 3 study testing BIIB041 (fampridine) in people with Multiple Sclerosis, Remittent Progressive and Multiple Sclerosis, Primary Progressive, run by Biogen at 19 sites in Japan.
Trial summary
This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Remittent Progressive, Multiple Sclerosis, Primary Progressive, Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- BIIB041 (fampridine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 19 sitesJapan
- Study dates
- Aug 2013to Mar 2017
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part A
- To be eligible to participate in Part A, candidates must meet the following eligibility criteria at screening or at the timepoint specified in the individual eligibility criterion listed (potential subjects who fail screening may be rescreened 1 time):
- Must have a diagnosis of primary-progressive, secondary progressive, progressive relapsing, or relapsing-remitting MS as defined by the revised McDonald Committee criteria ([Lublin and Reingold 1996; McDonald 2001; Polman 2005]) of at least 2 months duration.
- Must be able to complete the T25FW with or without a walking aid in 8 to 45 seconds at the screening visit.
- Part B
- To be eligible to participate in Part B, candidates must meet the following criteria at the Week 21 visit in Part A, which is the first visit for Part B:
Show all 10Show fewer
- 1. Completed all visits in Part A of the study.
- Part C
- To be eligible to participate in Part C, candidates must meet the following criteria at the Week 52 visit in Part B, which is the first visit for Part C:
- 1. Completed all visits in Part B of the study.
Who cannot join
- Known allergy to pyridine-containing substances, or any of the inactive ingredients of the prolonged-release fampridine tablet
- Any prior history of seizures, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood, or prior history of epileptiform activity on electroencephalogram.
- Any form of renal impairment as defined by a creatinine clearance (CrCl) of <80 mL/min (estimated by the central laboratory).
- Known history of cardiac arrhythmia or cardiac conduction disorders requiring medical or surgical intervention, or any clinically significant ECG abnormality (as determined by the Investigator) at the screening visit or Day 1.
- Any prior treatment with fampridine (4 AP) or 3,4 diaminopyridine in any formulation.
- Treatment with an investigational drug or approved therapy for investigational use within 30 days (or 5 half lives, whichever is longer) prior to the screening visit.
- Participation in an investigational study (with the exception of observational studies) within 30 days prior to the screening visit or plans to enroll in another interventional investigational study at any time during this study.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Research Site
Bunkyō City
Research Site
Chiba
Research Site
Fuchū
Research Site
Fukuoka
Research Site
Kawagoe-shi
Research Site
Kodaira-shi
Research Site
Kyoto
Research Site
Morioka
Research Site
Niigata
Research Site
Obihiro
Research Site
Osaka
Research Site
Ōta-ku
Research Site
Sapporo
Research Site
Sendai
Research Site
Shinjuku-ku
Research Site
Suita-shi
Research Site
Toon-shi
Research Site
Ube-shi
Research Site
Yachiyo-shi
About this study
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension
This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind portion of the study is to evaluate the safety and tolerability of prolonged-release Fampridine in this study population. The primary objective of the open-label extension study (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The primary objective of the additional open-label extension (Part C) is to provide participants who complete the study with continued access to prolonged-release fampridine until marketed drug can be used at the applicable site or until sponsor decision to discontinue the study.
- Conditions
- Multiple Sclerosis, Remittent Progressive, Multiple Sclerosis, Primary Progressive, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
- Being tested
- Placebo, BIIB041 (fampridine)
- Keywords
- Japan
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
matching placebo tablets
BIIB041 (fampridine)Drug
Also called Fampyra, prolonged-release fampridine, dalfampridine, Ampyra
fampridine prolonged-release tablets
| Study group | Role | What they receive |
|---|---|---|
| Part A Placebo | Placebo comparator | Part A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks. Receives: Drug: Placebo |
| Part A prolonged-release fampridine | Experimental | Part A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks. Receives: Drug: BIIB041 (fampridine) |
| Part B prolonged-release fampridine | Experimental | Part B: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily for up to 52 weeks. Receives: Drug: BIIB041 (fampridine) |
| Part C prolonged-release fampridine | Experimental | Part C: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily until marketed product is available. Receives: Drug: BIIB041 (fampridine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who show a consistent improvement in walking speed
Measured: Part A (Up to 21 Weeks)
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Part B (54 Weeks)
Secondary outcomes (1)
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Part A (Up to 21 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Remittent ProgressiveStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917019
- Sponsor's protocol ID
- 218MS304
- Acronym
- MOTION - JAPAN
- Status last verified
- Mar 2017
- First submitted
- 2 Aug 2013
- Last updated
- 21 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension
- ClinicalTrials.gov ID
- NCT01917019
- Acronym / sponsor ID
- MOTION - JAPAN / 218MS304
- Conditions
- Multiple Sclerosis, Remittent Progressive, Multiple Sclerosis, Primary Progressive, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
- Keywords
- Japan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Aug 2013 (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.
This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind portion of the study is to evaluate the safety and tolerability of prolonged-release Fampridine in this study population. The primary objective of the open-label extension study (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The primary objective of the additional open-label extension (Part C) is to provide participants who complete the study with continued access to prolonged-release fampridine until marketed drug can be used at the applicable site or until sponsor decision to discontinue the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Placebo | Placebo comparator | Drug: PlaceboPart A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks. |
| Part A prolonged-release fampridine | Experimental | Drug: BIIB041 (fampridine)Part A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks. |
| Part B prolonged-release fampridine | Experimental | Drug: BIIB041 (fampridine)Part B: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily for up to 52 weeks. |
| Part C prolonged-release fampridine | Experimental | Drug: BIIB041 (fampridine)Part C: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily until marketed product is available. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Part A
- To be eligible to participate in Part A, candidates must meet the following eligibility criteria at screening or at the timepoint specified in the individual eligibility criterion listed (potential subjects who fail screening may be rescreened 1 time):
- Must have a diagnosis of primary-progressive, secondary progressive, progressive relapsing, or relapsing-remitting MS as defined by the revised McDonald Committee criteria ([Lublin and Reingold 1996; McDonald 2001; Polman 2005]) of at least 2 months duration.
- Must be able to complete the T25FW with or without a walking aid in 8 to 45 seconds at the screening visit.
- Part B
Key exclusion criteria (8 listed)
- Known allergy to pyridine-containing substances, or any of the inactive ingredients of the prolonged-release fampridine tablet
- Any prior history of seizures, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood, or prior history of epileptiform activity on electroencephalogram.
- Any form of renal impairment as defined by a creatinine clearance (CrCl) of <80 mL/min (estimated by the central laboratory).
- Known history of cardiac arrhythmia or cardiac conduction disorders requiring medical or surgical intervention, or any clinically significant ECG abnormality (as determined by the Investigator) at the screening visit or Day 1.
- Any prior treatment with fampridine (4 AP) or 3,4 diaminopyridine in any formulation.
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 |
|---|---|---|
| Placebomatching placebo tablets | Drug | Part A Placebo |
| BIIB041 (fampridine)Also: Fampyra, prolonged-release fampridine, dalfampridine, Ampyrafampridine prolonged-release tablets | Drug | Part A prolonged-release fampridine, Part B prolonged-release fampridine, Part C prolonged-release fampridine |
Primary outcome
The proportion of participants who show a consistent improvement in walking speed
Time frame: Part A (Up to 21 Weeks)
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Part B (54 Weeks)
1 secondary outcome
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Part A (Up to 21 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 21 Mar 2017.
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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.
Medical Director study director
Biogen
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BIIB041 (fampridine) in people with Multiple Sclerosis, Remittent Progressive and Multiple Sclerosis, Primary Progressive, run by Biogen at 19 sites in Japan.
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 10 inclusion and 8 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The proportion of participants who show a consistent improvement in walking speed (time frame: Part A (Up to 21 Weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2017.