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NCT Number: NCT01656148

FAME - 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Esbjerg Hospital, Esbjerg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fampridine-SR

Drug

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Biogen
  • Region of Southern Denmark

Registry information

Official study title

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

Acronym: FAME

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2012
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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