Study of Milnacipran for the Treatment of Fibromyalgia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00098124 |
Recruitment Status :
Completed
First Posted : December 6, 2004
Last Update Posted : December 24, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia | Drug: milnacipran hydrochloride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 1200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia |
Study Start Date : | November 2004 |
Study Completion Date : | December 2006 |

- Composite responder analysis based on pain and patient global status, with or without physical function.
- Quality of Life
- Health Assessment Questionnaire (HAQ) Disability Index
- Fatigue, sleep and cognitive assessments

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- Sleep apnea
- Inflammatory bowel disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098124

ClinicalTrials.gov Identifier: | NCT00098124 |
Other Study ID Numbers: |
MLN-MD-02 |
First Posted: | December 6, 2004 Key Record Dates |
Last Update Posted: | December 24, 2007 |
Last Verified: | December 2007 |
NSRI milnacipran fibromyalgia |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Milnacipran Levomilnacipran Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs |