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

• Conditions: Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10016256Term: Fatigue

• Registration Number: EUCTR2008-008065-35-SE
• Lead Sponsor: BiogenIdec A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-17
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified