A EUROPEAN PHASE III, MULTICENTRE, DOUBLE-BLIND, RANDOMISED, MONOTHERAPY, 12-MONTH STUDY OF MILNACIPRAN FOR THE TREATMENT OF THE FIBROMYALGIA SYNDROME
- Registry ID
- EUCTR2006-001230-41
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- PIERRE FABRE MEDICAMENT
- Start date
- 2006-08-17
- Completion date
- 2008-10-02
- Last update
- 2026-08-16
Conditions
- Fibromyalgia Syndrome
- Fibromyalgia syndrome (FMS). FMS is a common systemic rheumatologic disorder estimated to affect 2 to 4% of the population. Fibromyalgia is associated with a reduced threshold for pain, generally identified by increased sensibility to pressure at particular points on the body, and is often accompanied by fatigue, sleep disturbance and morning stiffness. Other common symptoms include headhache, migraine, variable bowel habits, diffuse abdominal pain and urinary frequency.
- Fibromyalgia syndrome (FMS) is a common systemic rheumatologic disorder estimated to affect 2 to 4% of the population. Fibromyalgia is associated with a reduced threshold for pain, generally identified by increased sensibility to pressure at particular points on the body, and is often accompanied by fatigue, sleep disturbance and morning stiffness. Other common symptoms include headhache, migraine, variable bowel habits, diffuse abdominal pain and urinary frequency.
Summary
To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100, 150 and 200 mg daily.
Locations
- , , UK
- , , Denmark
- , , Germany
- , , Sweden
- , , Italy
- , , Finland
- , , Czechia
- , , Portugal
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