FMS European Long-Term Study - Full Text View

Sponsored by:	Pierre Fabre Medicament
Information provided by:	Pierre Fabre Medicament
ClinicalTrials.gov Identifier:	NCT00757731

Purpose

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

Condition	Intervention	Phase
Fibromyalgia Syndrome	Drug: milnacipran	Phase III

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Milnacipran hydrochloride Milnacipran

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A European Phase III, Multicentre, Double-Blind, Randomised, Monotherapy, 12-Month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

Further study details as provided by Pierre Fabre Medicament:

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

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

Enrollment:	468
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2008

Intervention Details:

hard capsule

Eligibility

Ages Eligible for Study:	18 Years to 71 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757731

Locations

Czech Republic
Rheumatology Ambulance
PARDUBICE, Czech Republic, 530 02
Finland
Kuopion Oma Laakari Oy
KUOPIO, Finland, 70100
France
Hopital Hotel Dieu
PARIS, France
Germany
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
Koln, Germany, D50931
Italy
Ospedale Luigi Sacco
MILANO, Italy, 20157
Norway
Center for Clinical Studies
LILLEHAMER, Norway, 2609
Portugal
Hospital Egas Moniz
LISBOA, Portugal, 1349-019
Romania
Dr I CANTACUZINO CLINICAL HOSPITAL
BUCHAREST, Romania, 020475
Spain
Hospital De La Esperanza
BARCELONA, Spain, 08024
Sweden
Gottfriesclinic Ab
MOLNDAL, Sweden, 43137

Sponsors and Collaborators

Pierre Fabre Medicament

Investigators

Principal Investigator:

Jaime C BRANCO, MD

HOSPITAL EGAS MONIZ, Lisboa, Portugal

More Information

No publications provided

Study ID Numbers:	F02207 GE 304
Study First Received:	September 22, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00757731 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Romania: National Medicines Agency; Czech Republic: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Fibromyalgia
Myofascial Pain Syndromes
Psychotropic Drugs
Pain
Rheumatic Diseases

Serotonin Uptake Inhibitors
Serotonin
Milnacipran
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Fibromyalgia
Myofascial Pain Syndromes
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Rheumatic Diseases

Serotonin Uptake Inhibitors
Pharmacologic Actions
Milnacipran
Serotonin Agents
Muscular Diseases
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Syndrome
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009