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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00793520
Other study ID # MLN-MD-16
Secondary ID
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. completion date
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


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
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