FMS European Long-Term Study

Fibromyalgia Syndrome Clinical Trial

Official title:

A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757731
• Other study ID #: F02207 GE 304
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2008
• Last updated: July 10, 2013
• Start date: September 2006
• Est. completion date: October 2008

Study information

• Verified date: July 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencyCzech Republic: State Institute for Drug ControlSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 71 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes

Intervention

Drug:
• milnacipran
hard capsule
• Placebo
hard capsule

Locations

Country	Name	City	State
Czech Republic	Rheumatology Ambulance	Pardubice
Finland	Kuopion Oma Laakari Oy	Kuopio
France	Hopital Hotel Dieu	Paris
Germany	KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care	Koln
Italy	Ospedale Luigi Sacco	Milano
Norway	Center For Clinical Studies	Lillehamer
Portugal	Hospital Egas Moniz	Lisboa
Romania	Dr I CANTACUZINO CLINICAL HOSPITAL	Bucharest
Spain	Hospital de La Esperanza	Barcelona
Sweden	Gottfriesclinic Ab	Molndal

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Czech Republic,  Finland,  France,  Germany,  Italy,  Norway,  Portugal,  Romania,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No