Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00793520
• Other study ID #: MLN-MD-16
• Status: Terminated
• Phase: Phase 3
• First received: November 17, 2008
• Last updated: June 1, 2010
• Start date: November 2008

Study information

• Verified date: June 2010
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria

• Visual analog pain score between 40 and 90 mm

• Right-hand dominance

Exclusion Criteria:

• Suicidal risk

• Substance Abuse

• Pulmonary dysfunction

• Renal impairment

• Active cardiac disease

• Autoimmune disease

• Uncontrolled narrow-angle glaucoma

• Active liver disease

• Cancer

• Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue

• Unstable endocrine disease

• Prostatic enlargement

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Milnacipran
Twice daily oral administration of Milnacipran for 5 weeks.
• Placebo
Twice daily oral administration of placebo for 5 weeks.
• Placebo
Twice daily oral administration of placebo for 5 weeks.
• Milnacipran
Twice daily oral administration of Milnacipran for 5 weeks.

Locations

Country	Name	City	State
United States	Forest Investigative Site	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.	Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.	Week 0, 5, 7 and 12	No
Secondary	Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.	DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 & 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient's right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC	Weeks 0, 5, 7 and 12	No