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

NCT01294059 | Completed Phase 1

• 1 other identifier: SAV-MD-06
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Hyperalgesia; Pain; Central Sensitization

Outcome Measures

Primary Outcomes (1)

• Mechanical and Heat Hyperalgesia

  2 week intervals

Secondary Outcomes (1)

• Clinical Pain

  daily

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

One sugar pill twice daily over 6 weeks

Drug: Milnacipran

Milnacipran

ACTIVE COMPARATOR

Milnacipran 50 mg bid over 6 weeks

Drug: Milnacipran

Interventions

Milnacipran DRUG

50 mg BID Oral x 6 Weeks

Also known as: Savella

Milnacipran; Sugar pill

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of chronic wide-spread pain for at least 3 months, who fulfill the 1990 ACR Criteria for FM.
• Patients with mean pain ratings ≥ 4.0 VAS units, at Screening and Baseline visits.
• Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
• 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).
• 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

You may not qualify if:

• FM patients unwilling or unable to discontinue analgesics (except Tylenol) for at least 5 drug half-lives prior to enrollment.
• Patient has previously failed treatment with Milnacipran for FM pain.
• Patients who have been treated with MAO inhibitors within 30 days prior to the Baseline Visit.
• Patients who received ECT within 3 months prior to the Screening Visit.
• 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.
• Patients who have participated in any clinical trial within one month prior to the Screening Visit.
• 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.
• Patients with severe renal insufficiency (Creatinine clearance \< 30 ml/min)
• Patient has a BDI score \>29
• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of Florida: lead
• Forest Laboratories: collaborator

Study Sites (1)

Center for Musculoskeletal Pain Research

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 25998206 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Hyperalgesia; Pain

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Roland Staud, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 11, 2011
• Study Start: November 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (1)