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

August 22, 2018 updated by: Henrik Boye Jensen, University of Southern Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Esbjerg Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Sønderborg, Denmark, 6400
        • Sønderborg Hospital
      • Vejle, Denmark, 7100
        • Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Fampyra (Ampyra in the US).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
SSST is measured before and at the end of four weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in T25FW
Time Frame: Four weeks
T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28.
Four weeks
Mean change in hip flexion, knee flexion and knee extension force
Time Frame: Four weeks
Force in the abovementioned areas is measured by dynamometry before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Four weeks
Mean change on Chair Rise Test
Time Frame: Four weeks
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.
Four weeks
Mean change on 9-Hole Peg Test (9HPT)
Time Frame: Four weeks
9HPT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Four weeks
Mean change on Symbol Digit Modalitites Test (SDMT)
Time Frame: Four weeks
SDMT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Biogen
Region of Southern Denmark

Investigators

  • Principal Investigator: Henrik B Jensen, MD, Institute for Regional Health Services Research, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAME
  • 2011-006151-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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