NCT01108731

The Effect of Milnacipran in Patients With Fibromyalgia

The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Beth Israel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients with Fibromyalgia will show elevated ventricular lactate levels as measured via magnetic resonance spectroscopy (MRS). Patients treated with Milnacipran will show normalization of ventricular lactate levels compared to those treated with placebo, and will also show normalization of the increased latency to respond to complex reaction time probes compared to those treated with placebo.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Milnacipran	Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
DRUG	Placebo	Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-04-22
• Last updated: 2016-06-30
• Results posted: 2014-10-15

Locations

1 site across 1 country: United States