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

NCT01173055 | Completed Phase 4 Results

• 1 other identifier: MD-SAV-09
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• Pain Threshold at Baseline

  The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm\^2.

  Baselines measured at week 0 and week 9 after washout from first assignment to treatment

• Change in Pain Threshold From Baseline to End of Treatment.

  The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm\^2. Lower values represent a worse outcome.

  baseline compared with 6 weeks of treatment

Secondary Outcomes (4)

• Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.

  Baselines measured at week 0 and week 9 after washout from first assignment to treatment

• Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.

  baseline compared with 6 weeks of treatment

• Pain Tolerance at Baseline

  Baselines measured at week 0 and week 9 after washout from first assignment to treatment

• Change in Pain Tolerance From Baseline to End of Treatment

  baseline compared wtih 6 weeks of treatment

Other Outcomes (3)

• Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment

  Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later

• Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)

  Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later

• Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment.

  Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later

Study Arms (2)

Milnacipran

EXPERIMENTAL

Milnacipran will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.

Drug: milnacipran

Placebo

EXPERIMENTAL

Placebo will be given orally twice daily in tablet form at different times during the course of the study.

Drug: Placebo

Interventions

milnacipran DRUG

Milnacipran will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.

Also known as: Savella

Milnacipran

Placebo DRUG

Placebo will be given orally twice daily in tablet form at different times during the course of the study.

Also known as: placebo/sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Michigan, Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

• Ichesco E, Peltier SJ, Mawla I, Harper DE, Pauer L, Harte SE, Clauw DJ, Harris RE. Prediction of Differential Pharmacologic Response in Chronic Pain Using Functional Neuroimaging Biomarkers and a Support Vector Machine Algorithm: An Exploratory Study. Arthritis Rheumatol. 2021 Nov;73(11):2127-2137. doi: 10.1002/art.41781. Epub 2021 Sep 22.

  PMID: 33982890 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran; Sugars

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Daniel Clauw, MD
• Organization: University of Michigan

dclauw@med.umich.edu

734-998-6901

Study Officials

• Daniel Clauw, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel Clauw, Professor of Anesthesiology, University of Michigan

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: July 30, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 8, 2017
• Results First Posted: February 20, 2015

Record last verified: 2017-10

Locations

US (1)