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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01294059
First received: February 9, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Fibromyalgia
Drug: Milnacipran

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Mechanical and Heat Hyperalgesia [ Time Frame: 2 week intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Pain [ Time Frame: daily ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
One sugar pill twice daily over 6 weeks
Drug: Milnacipran
50 mg BID Oral x 6 Weeks
Other Name: Savella
Active Comparator: Milnacipran
Milnacipran 50 mg bid over 6 weeks
Drug: Milnacipran
50 mg BID Oral x 6 Weeks
Other Name: Savella

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294059

Locations
United States, Florida
Center for Musculoskeletal Pain Research
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Forest Laboratories
Investigators
Principal Investigator: Roland Staud, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01294059     History of Changes
Other Study ID Numbers: SAV-MD-06
Study First Received: February 9, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Fibromyalgia
Hyperalgesia
Pain
Central Sensitization

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Hyperalgesia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on July 29, 2014