Study of Milnacipran for the Treatment of Fibromyalgia

A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00098124

Enrollment

1200

Registered

2004-12-06

Start date

2004-11-30

Completion date

2006-12-31

Last updated

2007-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

NSRI, milnacipran, fibromyalgia

Brief summary

Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.

Interventions

DRUGmilnacipran hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Composite responder analysis based on pain and patient global status, with or without physical function.	—

Secondary

Measure	Time frame
Quality of Life	—
Health Assessment Questionnaire (HAQ) Disability Index	—
Fatigue, sleep and cognitive assessments	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026