Phase 3 Completed N=362 Randomized Treatment

Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Fibromyalgia

Source: ClinicalTrials.gov NCT00797797 ↗

Enrolled (actual)

362

Serious AEs

3.0%

Results posted

Feb 2011

Primary outcomePrimary: Patient Global Impression of Change (PGIC) Responder Rate at End of Study — 36; 83; 137; 96 participants — p=<0.001

Summary

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Global Impression of Change (PGIC) Responder Rate at End of Study	36; 83; 137; 96	<0.001 sig
SECONDARY Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study	-6.43; -20.77	—

Eligibility Criteria

Inclusion Criteria

diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
tolerate at least 300 mg/day of pregabalin
have an incomplete response to pregabalin treatment

Exclusion Criteria

suicidal risk
substance abuse
pulmonary dysfunction
renal impairment
active cardiac disease
liver disease
narrow angle glaucoma
autoimmune disease
cancer
inflammatory bowel disease
unstable endocrine disease
prostatic enlargement

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00797797). 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. Informational only — not medical advice.