FAME - a study of the effect of Fampyra on muscle strength in the lower extremities, walking capacity, coordination in the upper extremitties and cognition in multiple sclerosis patients.

• Register: EUCTR
• Last refreshed on: 14 April 2014
• Main ID: EUCTR2011-006151-10-DK
• Date of registration: 15/02/2012
• Prospective Registration: Yes
• Primary sponsor: Sønderjylland Hospital, department of neurology
• Public title: FAME - a study of the effect of Fampyra on muscle strength in the lower extremities, walking capacity, coordination in the upper extremitties and cognition in multiple sclerosis patients.
• Scientific title: FAME - Fampyra outcome measures study: a study of responsiveness of different outcome measures to Fampyra treatment. - FAME
• Date of first enrolment: 15/02/2012
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006151-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark

Contacts

• Affiliation: Department of neurology, Sønderjylland Hospital

• Affiliation: Department of neurology, Sønderjylland Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria, aged 18-60 years, EDSS 4-7, pyramidal FS >= 2, able to transport self to University of Southern Denmark in Odense.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
History of epileptic seizures, relapses of multiple sclerosis or change in disease modifying therapy within 60 days, cancer within five years, uncontrolled hypertension or clinically important cardiac, hepatic, renal or pulmonary disease, pregnancy and concomitant tratment with cimetidine, carvedilol, propranolol or metformine.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Multiple Sclerosis

Intervention(s)

Trade Name: Fampyra
Product Name: Fampyra
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 9 weeks

Secondary Objective:

Main Objective: The aim of the trial is to compose a multiple outcome measure trial to
1. evaluate the relative sensitivity of a comprehensive series of clinical tests for the identification of multiple sclerosis patients that respond to Fampyra
2. compare the effect size of Fampyra treatment when assessed by the Six Spot Step Test

Primary end point(s): The mean change in six spot step test from day 0 to 28.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 9 weeks

Secondary end point(s): Mean changes in Timed 25 Foot Walk, Hip Flexion Dynamometry, Knee Extension Dynamometry, Chair Rise Test, 9 Hole Peg Test and Symbol Digit Modalities Test.

Secondary ID(s)

FAME1.0

Source(s) of Monetary Support

University of Southern Denmark

Biogen Idec

Department of Neurology, Odense Universityhospital

Region of Southern Denmark