FMS European Long-Term Study

Phase 3

Completed

• Conditions: Fibromyalgia Syndrome
• Interventions: Drug: milnacipran; Drug: Placebo

• Registration Number: NCT00757731
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

• patient who completed the 3-month F02207 GE 302 study
• patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study

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Exclusion Criteria

• known hypersensitivity to milnacipran
• major depressive episode
• significant risk of suicide
• generalised anxiety disorder
• substance abuse
• clinically significant cardiac disease
• pulmonary dysfunction
• active liver disease
• renal impairment
• autoimmune disease
• current systemic infection
• epileptic
• active cancer
• severe sleep apnoea
• active peptic ulcer
• inflammatory bowel disease
• unstable endocrine disease
• (for men) prostatic enlargement or other genito-urinary disorders
• (for women) pregnancy or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minalcipran 200 mg	Placebo	-
Minalcipran 100 mg	Placebo	-
Minalcipran 200 mg	milnacipran	-
Minalcipran 150 mg	Placebo	-
Minalcipran 150 mg	milnacipran	-
Minalcipran 100 mg	milnacipran	-

Primary Outcome Measures

Name	Time	Method
To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily	12 months

Secondary Outcome Measures

Name	Time	Method
To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily	12 months

Trial Locations

Locations (10)

Dr I CANTACUZINO CLINICAL HOSPITAL; 🇷🇴 Bucharest, Romania

Rheumatology Ambulance; 🇨🇿 Pardubice, Czech Republic

Kuopion Oma Laakari Oy; 🇫🇮 Kuopio, Finland

KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care; 🇩🇪 Koln, Germany

Hopital Hotel Dieu; 🇫🇷 Paris, France

Center For Clinical Studies; 🇳🇴 Lillehamer, Norway

Ospedale Luigi Sacco; 🇮🇹 Milano, Italy

Hospital Egas Moniz; 🇵🇹 Lisboa, Portugal

Gottfriesclinic Ab; 🇸🇪 Molndal, Sweden

Hospital de La Esperanza; 🇪🇸 Barcelona, Spain