FMS European Long-Term Study

Sponsor

Pierre Fabre Medicament (Industry)

Overall Status

Completed

CT.gov ID

NCT00757731

Collaborator

(none)

490

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome	Drug: milnacipran Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

490 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Minalcipran 100 mg	Drug: milnacipran hard capsule Drug: Placebo hard capsule
Experimental: Minalcipran 150 mg	Drug: milnacipran hard capsule Drug: Placebo hard capsule
Experimental: Minalcipran 200 mg	Drug: milnacipran hard capsule Drug: Placebo hard capsule

Arm

Intervention/Treatment

Experimental: Minalcipran 100 mg

Drug: milnacipran

hard capsule

Drug: Placebo

hard capsule

Experimental: Minalcipran 150 mg

Drug: milnacipran

hard capsule

Drug: Placebo

hard capsule

Experimental: Minalcipran 200 mg

Drug: milnacipran

hard capsule

Drug: Placebo

hard capsule

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 71 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Rheumatology Ambulance	Pardubice	Czech Republic	530 02
2	Kuopion Oma Laakari Oy	Kuopio	Finland	70100
3	Hopital Hotel Dieu	Paris	France
4	KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care	Koln	Germany	D50931
5	Ospedale Luigi Sacco	Milano	Italy	20157
6	Center For Clinical Studies	Lillehamer	Norway	2609
7	Hospital Egas Moniz	Lisboa	Portugal	1349-019
8	Dr I CANTACUZINO CLINICAL HOSPITAL	Bucharest	Romania	020475
9	Hospital de La Esperanza	Barcelona	Spain	08024
10	Gottfriesclinic Ab	Molndal	Sweden	43137