Study of Milnacipran for the Treatment of Fibromyalgia

Study Description

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Brief Summary:

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: Placebo; Drug: Milnacipran 100mg	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1025 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Study Start Date :	April 2006
Actual Primary Completion Date :	June 2008

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo, oral administration, twice daily for 12 weeks	Drug: Placebo; Placebo, oral administration, twice daily for 12 weeks
Experimental: Milnacipran; Milnacipran 100mg/day (50mg BID [twice a day])	Drug: Milnacipran 100mg; Milnacipran 100mg per day (50mg BID [twice a day])

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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) ]
2. 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 ]
3. 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) ]
4. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 24 Study Locations

Sponsors and Collaborators

Forest Laboratories

Cypress Bioscience, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.

Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.

Responsible Party:	Robert Palmer, MD, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00314249 History of Changes
Other Study ID Numbers:	MLN-MD-03
First Posted:	April 13, 2006
Results First Posted:	November 2, 2009
Last Update Posted:	January 20, 2010
Last Verified:	January 2010

Keywords provided by Forest Laboratories:

Fibromyalgia

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Milnacipran; Antidepressive Agents; Psychotropic Drugs	Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Adrenergic Uptake Inhibitors; Adrenergic Agents