Phase 3 N=1,025 Randomized Double-blind Treatment

Study of Milnacipran for the Treatment of Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT00314249 ↗

Enrolled (actual)

1,025

Serious AEs

1.7%

Results posted

Nov 2009

Primary outcome: Primary: Composite Syndrome Responder Status — 56; 103 Syndrome Responder Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Milnacipran 100mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Syndrome Responder Status	56; 103	<0.001 sig
PRIMARY Composite Pain Responder Status	90; 147	<0.001 sig
SECONDARY Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase	48.0; 41.2	—
SECONDARY Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.	3.4; 2.9	—
SECONDARY Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.	-3.96; -5.50	—
SECONDARY Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12	36.4; 37.9	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00314249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.