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Phase 4 N=22 Randomized Triple-blind Basic Science

A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT01173055 ↗
Enrolled (actual)
22
Serious AEs
2.5%
Results posted
Feb 2015
Primary outcome: Primary: Pain Threshold at Baseline — 2.7333; 2.583 kg/cm^2

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
milnacipran (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of Michigan
Primary completion
Jun 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Threshold at Baseline		 2.7333; 2.583 —
PRIMARY
Change in Pain Threshold From Baseline to End of Treatment.		 2.7333; 2.583; 2.650; 2.70 —
SECONDARY
Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.		 8.134; 12.0240 —
SECONDARY
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.		 8.134; 12.0240; 11.0355; 8.50 —
SECONDARY
Pain Tolerance at Baseline		 4.2667; 3.80 —
SECONDARY
Change in Pain Tolerance From Baseline to End of Treatment		 4.2667; 3.80; 3.8667; 3.8667 —

Summary

Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue. Researchers want to find out if "a drug" called milnacipran can help people with fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of fibromyalgia. In this study, milnacipran will be given to find out more about how it affects pain and thinking in people with fibromyalgia.

Eligibility Criteria

Inclusion Criteria

  • You may be eligible to take part in this study if the following are true:
  • You are between the age of 18 and 70 years
  • If you are female
  • If you are right handed
  • You have a diagnosis of fibromyalgia for at least 3 months, as defined by the American College of Rheumatology 1990 Criteria
  • You are willing to stop taking certain medicines that you may be taking on a regular basis. The researchers will discuss these medications with you in detail

Exclusion Criteria

  • You may not be eligible take part in this study if any of the following are true for you:
  • You have problems with your heart or cardiovascular system
  • You have problems with your liver or kidneys
  • You have an autoimmune disease, or a whole-body infection like HIV or hepatitis
  • You have cancer
  • You are pregnant or breastfeeding
  • You abuse drugs or alcohol
  • You have suicidal thoughts or wishes
  • You have taken milnacipran or another study drug within the last 30 days
  • You have a medical problem not listed here that would make it unsafe for you to take part in the study
  • The research team feels that you will be unable to complete all phases of the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01173055). 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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