Study of Milnacipran for the Treatment of Fibromyalgia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00314249
• Date of registration: 11/04/2006
• Primary sponsor: Forest Laboratories
• Public title: Study of Milnacipran for the Treatment of Fibromyalgia
• Scientific title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
• Date of first enrolment: April 2006
• Target sample size: 1025
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00314249
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR)
Criteria

Exclusion Criteria:

- psychiatric illness,

- depression,

- suicidal risk,

- substance abuse,

- pulmonary dysfunction,

- renal impairment,

- active cardiac disease,

- liver disease,

- autoimmune disease,

- cancer,

- inflammatory bowel disease



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fibromyalgia

Intervention(s)

Drug: Milnacipran 100mg

Drug: Placebo

Primary Outcome(s)

Composite Pain Responder Status [Time Frame: At the end of three-month stable dose treatment phase]

Composite Syndrome Responder Status [Time Frame: At the end of the three-month stable dose treatment phase]

Secondary Outcome(s)

Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. [Time Frame: Baseline through end of week 12 (Visit TX12)]

Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase [Time Frame: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)]

Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. [Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase]

Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 [Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase]

Secondary ID(s)

MLN-MD-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cypress Bioscience, Inc.