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Clinical Trials/EUCTR2011-006151-10-DK
EUCTR2011-006151-10-DK
Active, not recruiting
Not Applicable

FAME - Fampyra outcome measures study: a study of responsiveness of different outcome measures to Fampyra treatment. - FAME

Sønderjylland Hospital, department of neurology0 sitesFebruary 15, 2012
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ConditionsMultiple SclerosisTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsFampyra

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Sønderjylland Hospital, department of neurology
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 15, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Sønderjylland Hospital, department of neurology

Eligibility 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.

Outcomes

Primary Outcomes

Not specified

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