FMS European Long-Term Study

NCT00757731 | Completed Phase 3

• 1 other identifier: F02207 GE 304
• Study Type: interventional
• Target: 490
• Locations: 10 countries
• Sites: 10

Brief Summary

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

Conditions

Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Minalcipran 100 mg

EXPERIMENTAL

Drug: milnacipran; Drug: Placebo

Minalcipran 150 mg

EXPERIMENTAL

Drug: milnacipran; Drug: Placebo

Minalcipran 200 mg

EXPERIMENTAL

Drug: milnacipran; Drug: Placebo

Interventions

milnacipran DRUG

hard capsule

Minalcipran 100 mg; Minalcipran 150 mg; Minalcipran 200 mg

Placebo DRUG

hard capsule

Minalcipran 100 mg; Minalcipran 150 mg; Minalcipran 200 mg

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (10)

Rheumatology Ambulance

Pardubice, 530 02, Czechia

Location

Kuopion Oma Laakari Oy

Kuopio, 70100, Finland

Location

Hopital Hotel Dieu

Paris, France

Location

KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care

Cologne, D50931, Germany

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Center For Clinical Studies

Lillehamer, 2609, Norway

Location

Hospital Egas Moniz

Lisbon, 1349-019, Portugal

Location

Dr I CANTACUZINO CLINICAL HOSPITAL

Bucharest, 020475, Romania

Location

Hospital de La Esperanza

Barcelona, 08024, Spain

Location

Gottfriesclinic Ab

Mölndal, 43137, Sweden

Location

Related Publications (1)

• Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.

  PMID: 21459941 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jaime C BRANCO, MD

  HOSPITAL EGAS MONIZ, Lisboa, Portugal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: September 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

RO (1); ES (1); FI (1); FR (1); SE (1); DE (1); CZ (1); PT (1); NO (1); IT (1)