NCT00436033

Brief Summary

Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,429

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
13 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

1.6 years

First QC Date

February 15, 2007

Last Update Submit

July 10, 2013

Conditions

Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion

    12 weeks

Secondary Outcomes (2)

  • comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria

    12 weeks

  • establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).

    19 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Minalcipran

EXPERIMENTAL
Drug: milnacipran

Interventions

milnacipranDRUG
Minalcipran
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

You may not qualify if:

  • psychiatric illness
  • depression of generalised anxiety disorder
  • suicidal risk
  • substance abuse
  • active cardiac disease
  • pulmonary dysfunction
  • liver disease
  • renal impairment
  • autoimmune disease
  • chronic inflammatory rheumatoid disease
  • current systemic infection
  • epileptic
  • active cancer
  • sleep apnea
  • active peptic ulcer
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Rheumatology Ambulance

Pardubice, 530 02, Czechia

Location

FREDERIKSBERG HOSPITAL - Clinic of Rheumatology

Frederiksberg, F2000, Denmark

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

"Nasz Lekarz"

Torun, Poland

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

KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology

London, SE59RJ, United Kingdom

Location

Related Publications (1)

  • Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.

    PMID: 20156949DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Dr Jaime C BRANCO

    HOSPITAL EGAS MONIZ

    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

February 15, 2007

First Posted

February 16, 2007

Study Start

February 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

CZ(1)FI(1)IT(1)NO(1)SE(1)PL(1)FR(1)ES(1)GB(1)PT(1)DK(1)DE(1)RO(1)