FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

This study has been completed.
Sponsor:
Collaborators:
Region Southern Denmark
Biogen Idec
Information provided by (Responsible Party):
Henrik Boye Jensen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01656148
First received: July 31, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: Fampridine-SR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • The mean change in SSST [ Time Frame: SSST is measured before and at the end of four weeks of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean change in T25FW [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28.

  • Mean change in hip flexion, knee flexion and knee extension force [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    Force in the abovementioned areas is measured by dynamometry before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.

  • Mean change on Chair Rise Test [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    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.

  • Mean change on 9-Hole Peg Test (9HPT) [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    9HPT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.

  • Mean change on Symbol Digit Modalitites Test (SDMT) [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    SDMT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.


Estimated Enrollment: 125
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fampridine-SR
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.
Drug: Fampridine-SR
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.
Other Name: Fampyra (Ampyra in the US).
Placebo Comparator: Placebo
In the intervention phase 50% will receive placebo BID
Drug: Fampridine-SR
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.
Other Name: Fampyra (Ampyra in the US).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria
  • EDSS 4-7
  • Pyramidal FS >= 2

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656148

Locations
Denmark
Esbjerg Hospital
Esbjerg, Denmark, 6700
Odense University Hospital
Odense, Denmark, 5000
Sønderborg Hospital
Sønderborg, Denmark, 6400
Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
University of Southern Denmark
Region Southern Denmark
Biogen Idec
Investigators
Principal Investigator: Henrik B Jensen, MD Institute for Regional Health Services Research, University of Southern Denmark
  More Information

Publications:

Responsible Party: Henrik Boye Jensen, MD, PhD Fellow, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01656148     History of Changes
Other Study ID Numbers: FAME, 2011-006151-10
Study First Received: July 31, 2012
Last Updated: May 9, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Southern Denmark:
Multiple sclerosis
Walking disablility
Mobility
Six Spot Step Test
Outcome measures
Fampridine-SR
Fampyra

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014