Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01294059
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : July 31, 2014
Forest Laboratories
Information provided by (Responsible Party):
University of Florida

February 9, 2011
February 11, 2011
July 31, 2014
November 2009
April 2014   (Final data collection date for primary outcome measure)
Mechanical and Heat Hyperalgesia [ Time Frame: 2 week intervals ]
Same as current
Complete list of historical versions of study NCT01294059 on Archive Site
Clinical Pain [ Time Frame: daily ]
Same as current
Not Provided
Not Provided
Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients
Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients
Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical) found in almost all FM patients. Milnacipran, a balance norepinephrine-serotonin re-uptake inhibitor, has been found to reduce pain and improve physical function of FM patients. However, little is known about the pain mechanisms that are affected by this medication. Therefore, the investigator wants to determine the efficacy of milnacipran in reducing pain as well as mechanical and thermal hyperalgesia of FM patients during a randomized, double-blind, placebo controlled trial. Because the investigator expects anti-hyperalgesic effects to coincide or precede with effects on clinical FM pain the proposed duration for this trial is 6 weeks.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Drug: Milnacipran
50 mg BID Oral x 6 Weeks
Other Name: Savella
  • Placebo Comparator: Sugar pill
    One sugar pill twice daily over 6 weeks
    Intervention: Drug: Milnacipran
  • Active Comparator: Milnacipran
    Milnacipran 50 mg bid over 6 weeks
    Intervention: Drug: Milnacipran
Staud R, Lucas YE, Price DD, Robinson ME. Effects of milnacipran on clinical pain and hyperalgesia of patients with fibromyalgia: results of a 6-week randomized controlled trial. J Pain. 2015 Aug;16(8):750-9. doi: 10.1016/j.jpain.2015.04.010. Epub 2015 May 19.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with diagnosis of chronic wide-spread pain for at least 3 months, who fulfill the 1990 ACR Criteria for FM.
  2. Patients with mean pain ratings ≥ 4.0 VAS units, at Screening and Baseline visits.
  3. Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
  4. Patients who have not taken any pain medications except acetaminophen within 3 days prior to the Baseline Visit (these medications if taken prior to the Screening Visit must be discontinued at Screening Visit and the Baseline Visit may be scheduled at least 7 days past the last dose of these medications).
  5. All women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the Screening Visit. All women of childbearing potential participating in the study must use a medically acceptable form of contraception

Exclusion Criteria:

  1. FM patients unwilling or unable to discontinue analgesics (except Tylenol) for at least 5 drug half-lives prior to enrollment.
  2. Patient has previously failed treatment with Milnacipran for FM pain.
  3. Patients who have been treated with MAO inhibitors within 30 days prior to the Baseline Visit.
  4. Patients who received ECT within 3 months prior to the Screening Visit.
  5. Women who are pregnant or nursing, or women of childbearing potential who do not use adequate contraception, or who are judged to be unreliable in their use of contraception.
  6. Patients who have participated in any clinical trial within one month prior to the Screening Visit.
  7. Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
  8. Patients with severe renal insufficiency (Creatinine clearance < 30 ml/min)
  9. Patient has a BDI score >29
  10. Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
  11. Patients with systolic blood pressure greater than 180 mm Hg or less than 90 mm Hg or diastolic blood pressure greater than 105 mm Hg or less than 50 mm Hg at the Screening visit. Similarly, tachycardia of >110/min is exclusionary.
  12. Patients who require concomitant therapy with any prohibited prescription or over-the-counter medication, including aspirin (except 81 mg for heart disease) or antidepressant medications.
  13. Patients who are unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Florida
University of Florida
Forest Laboratories
Principal Investigator: Roland Staud, MD University of Florida
University of Florida
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP