Phase 3 Completed N=34 Randomized Quadruple-blind Treatment

The Effect of Milnacipran in Patients With Fibromyalgia

Source: ClinicalTrials.gov NCT01108731 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcomePrimary: Change in Ventricular Lactate Levels in the Brain — -0.87; 0.32 international units (iu) — p=<0.05

Summary

Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Ventricular Lactate Levels in the Brain	-0.87; 0.32	<0.05 sig
SECONDARY Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).	-79.56; -35.00; -68.73; -34.77	<0.05 sig
SECONDARY Change in Widespread Pain	-1.24; 0.66	<0.05 sig

Eligibility Criteria

Inclusion Criteria

Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
18 through 68 years of age

Exclusion Criteria

Pregnant or trying to become pregnant
Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
Patients who do not indicate their pain levels as less than substantial despite their best care
History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
Presence of current depression as determined by psychiatric diagnostic interview
Presence of brain lesion on MRI anatomical study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01108731). 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.