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Clinical Trials/EUCTR2008-008065-35-SE
EUCTR2008-008065-35-SE
Active, not recruiting
Not Applicable

A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGY

BiogenIdec A/S0 sites200 target enrollmentDecember 17, 2008
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ConditionsMutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10016256Term: Fatigue
DrugsTysabri

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis
Sponsor
BiogenIdec A/S
Enrollment
200
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 17, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
BiogenIdec A/S

Eligibility Criteria

Inclusion Criteria

  • •Age \= 18 years and age \= 65 years at screening
  • •Subjects who have been prescribed Tysabri® according to national guidelines but not yet started treatment
  • •Signed informed consent form (ICF)
  • •FSMC sum score \= 43 at baseline (mild fatigue)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years)
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •FSMC sum score \< 43 at baseline
  • •History of treatment with Tysabri®
  • •EDSS \= 6 at baseline
  • •Amphetamine as medication
  • •Major depression

Outcomes

Primary Outcomes

Not specified

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