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Phase 3 N=34 Randomized Quadruple-blind Treatment

The Effect of Milnacipran in Patients With Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT01108731 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Change in Ventricular Lactate Levels in the Brain — -0.87; 0.32 international units (iu) — p=<0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Milnacipran (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Beth Israel Medical Center
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-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

Summary

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

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.

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