Multiple SclerosisPhase 4FAMENCT01656148
FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
A Phase 4 study testing Fampridine-SR in people with Multiple Sclerosis, run by University of Southern Denmark at 4 sites in Denmark.
Trial summary
Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fampridine-SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 4 sitesDenmark
- Study dates
- Jun 2012to May 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria
- EDSS 4-7
- Pyramidal FS >= 2
Who cannot join
- History of epileptic seizures
- MS relapse or change in disease modifying treatment (DMT) within 60 days
- cancer within five years
- uncontrolled hypertension
- clinically important cardiac, hepatic, renal or pulmonary disease
- pregnancy
- breast feeding
- concomitant treatment with cimetidine, carvedilol, propranolol and metformin
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Esbjerg Hospital
Esbjerg, 6700
Odense University Hospital
Odense, 5000
Sønderborg Hospital
Sønderborg, 6400
Vejle Hospital
Vejle, 7100
About this study
Official title: Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not been investigated in patients responding to the drug measured by the abovementioned test.
The question is if this will be the case and also if another walking test, termed the Six Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.
Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not less sensitive to the effect of Fampridine-SR than T25FW.
- Conditions
- Multiple Sclerosis
- Being tested
- Fampridine-SR
- Keywords
- Multiple sclerosis, Walking disablility, Mobility, Six Spot Step Test, Outcome measures, Fampridine-SR, Fampyra
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fampridine-SRDrug
Also called Fampyra (Ampyra in the US).
Subjects will all receive Fampridine-SR in an open label enrichment phase lasting four weeks. Those 40% improvin the most measured by SSST will go onto the intervention. Here randomization in a 1:1 key between Fampridine-SR and placebo will be undertaken. Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks. Arms will be double blind.
| Study group | Role | What they receive |
|---|---|---|
| Fampridine-SR | Experimental | Initially all participants receive Fampridine-SR 10 mg BID in an open label enrichment phase lasting four weeks. Those 40% responding the most by SSST will go onto phase two. 50% of these will receive 10 mg Fampridine-SR BID for four weeks. Receives: Drug: Fampridine-SR |
| Placebo | Placebo comparator | In the intervention phase 50% will receive placebo BID Receives: Drug: Fampridine-SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in SSST
SSST is measured before treatment with Fampridine-SR. Then again measured at day 26, 27 or 28 of four weeks of treatment with Fampridine-SR.
Measured: SSST is measured before and at the end of four weeks of treatment
Secondary outcomes (5)
Mean change in T25FW
T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28.
Measured: Four weeks
Mean change in hip flexion, knee flexion and knee extension force
Force in the abovementioned areas is measured by dynamometry before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Measured: Four weeks
Mean change on Chair Rise Test
Time to rise from a chair five times is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Measured: Four weeks
Mean change on 9-Hole Peg Test (9HPT)
9HPT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Measured: Four weeks
Mean change on Symbol Digit Modalitites Test (SDMT)
SDMT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Biogen
- Responsible party
- Principal investigator, Henrik Boye Jensen, University of Southern Denmark
- Investigators
- Henrik B Jensen, MD, Principal investigator, Institute for Regional Health Services Research, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656148
- Sponsor's protocol ID
- FAME
- Other IDs
- 2011-006151-10
- Acronym
- FAME
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2012
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Solari A, Uitdehaag B, Giuliani G, Pucci E, Taus C. Aminopyridines for symptomatic treatment in multiple sclerosis. Cochrane Database Syst Rev. 2002;(4):CD001330. doi: 10.1002/14651858.CD001330.
PubMed 12804404Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.
PubMed 16472864Schwid SR, Petrie MD, McDermott MP, Tierney DS, Mason DH, Goodman AD. Quantitative assessment of sustained-release 4-aminopyridine for symptomatic treatment of multiple sclerosis. Neurology. 1997 Apr;48(4):817-21. doi: 10.1212/wnl.48.4.817.
PubMed 9109861Goodman AD, Cohen JA, Cross A, Vollmer T, Rizzo M, Cohen R, Marinucci L, Blight AR. Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study. Mult Scler. 2007 Apr;13(3):357-68. doi: 10.1177/1352458506069538. Epub 2007 Jan 29.
PubMed 17439905Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
PubMed 19249634Goodman AD, Brown TR, Cohen JA, Krupp LB, Schapiro R, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F202 Study Group. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008 Oct 7;71(15):1134-41. doi: 10.1212/01.wnl.0000326213.89576.0e. Epub 2008 Jul 30.
PubMed 18672472Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
PubMed 20976768Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.
PubMed 10355672Nieuwenhuis MM, Van Tongeren H, Sorensen PS, Ravnborg M. The six spot step test: a new measurement for walking ability in multiple sclerosis. Mult Scler. 2006 Aug;12(4):495-500. doi: 10.1191/1352458506ms1293oa.
PubMed 16900764Jensen HB, Nielsen JL, Ravnborg M, Dalgas U, Aagaard P, Stenager E. Effect of slow release-Fampridine on muscle strength, rate of force development, functional capacity and cognitive function in an enriched population of MS patients. A randomized, double blind, placebo controlled study. Mult Scler Relat Disord. 2016 Nov;10:137-144. doi: 10.1016/j.msard.2016.07.019. Epub 2016 Sep 14.
PubMed 27919481Jensen H, Ravnborg M, Mamoei S, Dalgas U, Stenager E. Changes in cognition, arm function and lower body function after slow-release Fampridine treatment. Mult Scler. 2014 Dec;20(14):1872-80. doi: 10.1177/1352458514533844. Epub 2014 May 22.
PubMed 24852920
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
- ClinicalTrials.gov ID
- NCT01656148
- Acronym / sponsor ID
- FAME / FAME
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Walking disablility, Mobility, Six Spot Step Test, Outcome measures, Fampridine-SR, Fampyra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Biogen
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Aug 2012 (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.
Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not been investigated in patients responding to the drug measured by the abovementioned test.
The question is if this will be the case and also if another walking test, termed the Six Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.
Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not less sensitive to the effect of Fampridine-SR than T25FW.
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-SR | Experimental | Drug: Fampridine-SRInitially all participants receive Fampridine-SR 10 mg BID in an open label enrichment phase lasting four weeks. Those 40% responding the most by SSST will go onto phase two. 50% of these will receive 10 mg Fampridine-SR BID for four weeks. |
| Placebo | Placebo comparator | Drug: Fampridine-SRIn the intervention phase 50% will receive placebo BID |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria
- EDSS 4-7
- Pyramidal FS >= 2
Key exclusion criteria (8 listed)
- History of epileptic seizures
- MS relapse or change in disease modifying treatment (DMT) within 60 days
- cancer within five years
- uncontrolled hypertension
- clinically important cardiac, hepatic, renal or pulmonary disease
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 |
|---|---|---|
| Fampridine-SRAlso: Fampyra (Ampyra in the US).Subjects will all receive Fampridine-SR in an open label enrichment phase lasting four weeks. Those 40% improvin the most measured by SSST will go onto the intervention. Here randomization in a 1:1 key between Fampridine-SR and placebo will be undertaken. Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks. Arms will be double blind. | Drug | Fampridine-SR, Placebo |
Primary outcome
The mean change in SSST
Time frame: SSST is measured before and at the end of four weeks of treatment
SSST is measured before treatment with Fampridine-SR. Then again measured at day 26, 27 or 28 of four weeks of treatment with Fampridine-SR.
5 secondary outcomes
Mean change in T25FW
Time frame: Four weeks
Mean change in hip flexion, knee flexion and knee extension force
Time frame: Four weeks
Mean change on Chair Rise Test
Time frame: Four weeks
Mean change on 9-Hole Peg Test (9HPT)
Time frame: Four weeks
Mean change on Symbol Digit Modalitites Test (SDMT)
Time frame: Four 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 23 Aug 2018.
- Background: PubMed 12804404Solari A, Uitdehaag B, Giuliani G, Pucci E, Taus C. Aminopyridines for symptomatic treatment in multiple sclerosis. Cochrane Database Syst Rev. 2002;(4):CD001330. doi: 10.1002/14651858.CD001330.
- Background: PubMed 16472864Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.
- Background: PubMed 9109861Schwid SR, Petrie MD, McDermott MP, Tierney DS, Mason DH, Goodman AD. Quantitative assessment of sustained-release 4-aminopyridine for symptomatic treatment of multiple sclerosis. Neurology. 1997 Apr;48(4):817-21. doi: 10.1212/wnl.48.4.817.
- Background: PubMed 17439905Goodman AD, Cohen JA, Cross A, Vollmer T, Rizzo M, Cohen R, Marinucci L, Blight AR. Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study. Mult Scler. 2007 Apr;13(3):357-68. doi: 10.1177/1352458506069538. Epub 2007 Jan 29.
- Background: PubMed 19249634Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
- Background: PubMed 18672472Goodman AD, Brown TR, Cohen JA, Krupp LB, Schapiro R, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F202 Study Group. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008 Oct 7;71(15):1134-41. doi: 10.1212/01.wnl.0000326213.89576.0e. Epub 2008 Jul 30.
- Background: PubMed 20976768Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
- Background: PubMed 10355672Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.
- Background: PubMed 16900764Nieuwenhuis MM, Van Tongeren H, Sorensen PS, Ravnborg M. The six spot step test: a new measurement for walking ability in multiple sclerosis. Mult Scler. 2006 Aug;12(4):495-500. doi: 10.1191/1352458506ms1293oa.
- Derived from this study: PubMed 27919481Jensen HB, Nielsen JL, Ravnborg M, Dalgas U, Aagaard P, Stenager E. Effect of slow release-Fampridine on muscle strength, rate of force development, functional capacity and cognitive function in an enriched population of MS patients. A randomized, double blind, placebo controlled study. Mult Scler Relat Disord. 2016 Nov;10:137-144. doi: 10.1016/j.msard.2016.07.019. Epub 2016 Sep 14.
- Derived from this study: PubMed 24852920Jensen H, Ravnborg M, Mamoei S, Dalgas U, Stenager E. Changes in cognition, arm function and lower body function after slow-release Fampridine treatment. Mult Scler. 2014 Dec;20(14):1872-80. doi: 10.1177/1352458514533844. Epub 2014 May 22.
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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.
Henrik B Jensen, MD principal investigator
Institute for Regional Health Services Research, University of Southern Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fampridine-SR in people with Multiple Sclerosis, run by University of Southern Denmark at 4 sites in Denmark.
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 3 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
The mean change in SSST (time frame: SSST is measured before and at the end of four weeks of treatment). 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 NCT01656148, which also lists 11 linked publications.
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 23 Aug 2018.