Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797797
• Other study ID #: MLN-MD-15
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2008
• Last updated: January 20, 2011
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: January 2010
• Est. primary completion date: November 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

• tolerate at least 300 mg/day of pregabalin

• have an incomplete response to pregabalin treatment

Exclusion Criteria:

• suicidal risk

• substance abuse

• pulmonary dysfunction

• renal impairment

• active cardiac disease

• liver disease

• narrow angle glaucoma

• autoimmune disease

• cancer

• inflammatory bowel disease

• unstable endocrine disease

• prostatic enlargement

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• No Treatment Added
No added treatment
• Milnacipran Added
Milnacipran 100 mg/d added

Locations

Country	Name	City	State
United States	Forest Investigative Site	Albuquerque	New Mexico
United States	Forest Investigative Site	Anaheim	California
United States	Forest Investigative Site	Atlanta	Georgia
United States	Forest Investigative Site	Baltimore	Maryland
United States	Forest Investigative Site	Bellevue	Washington
United States	Forest Investigative Site	Bellingham	Washington
United States	Forest Investigative Site	Birmingham	Alabama
United States	Forest Investigative Site	Cincinnati	Ohio
United States	Forest Investigative Site	Clearwater	Florida
United States	Forest Investigative Site	Cleveland	Ohio
United States	Forest Investigative Site	Couer D'Alene	Idaho
United States	Forest Investigative Site	Cromwell	Connecticut
United States	Forest Investigative Site	Danbury	Connecticut
United States	Forest Investigative Site	Daytona Beach	Florida
United States	Forest Investigative Site	Delray Beach	Florida
United States	Forest Investigative Site	Denver	Colorado
United States	Forest Investigative Site	Eugene	Oregon
United States	Forest Investigative Site	Evansville	Indiana
United States	Forest Investigative Site	Fort Myers	Florida
United States	Forest Investigative Site	Greer	South Carolina
United States	Forest Investigative Site	Honolulu	Hawaii
United States	Forest Investigative Site	Hot Springs	Arkansas
United States	Forest Investigative Site	Houston	Texas
United States	Forest Investigative Site	Houston	Texas
United States	Forest Investigative Site	Indianapolis	Indiana
United States	Forest Investigative Site	Indianapolis	Indiana
United States	Forest Investigative Site	Jackson	Mississippi
United States	Forest Investigative Site	Jacksonville	Florida
United States	Forest Investigative Site	Lake Jackson	Texas
United States	Forest Investigative Site	Medford	Oregon
United States	Forest Investigative Site	Memphis	Tennessee
United States	Forest Investigative Site	Mesa	Arizona
United States	Forest Investigative Site	Miami	Florida
United States	Forest Investigative Site	No. Dartmouth	Massachusetts
United States	Forest Investigative Site	Ocala	Florida
United States	Forest Investigative Site	Omaha	Nebraska
United States	Forest Investigative Site	Orlando	Florida
United States	Forest Investigative Site Orl2	Orlando	Florida
United States	Forest Investigative Site	Ormond Beach	Florida
United States	Forest Investigative Site PP1	Pembroke Pines	Florida
United States	Forest Investigative Site PP2	Pembroke Pines	Florida
United States	Forest Investigative Site	Peoria	Arizona
United States	Forest Investigative Site	Pismo Beach	Florida
United States	Forest Investigative Site	Portland	Oregon
United States	Forest Investigative Site	Racine	Wisconsin
United States	Forest Investigative Site	Sacramento	California
United States	Forest Investigative Site	Sacramento	California
United States	Forest Investigative Site	Salt Lake City	Utah
United States	Forest Investigative Site	Salt Lake City	Utah
United States	Forest Investigative Site SEA1	Seattle	Washington
United States	Forest Investigative Site SEA2	Seattle	Washington
United States	Forest Investigative Site	Spokane	Washington
United States	Forest Investigative Site	St. Louis	Missouri
United States	Forest Investigative Site	St. Petersburg	Florida
United States	Forest Investigative Site	Syracuse	New York
United States	Forest Investigative Site	Tampa	Florida
United States	Forest Investigative Site	Torrance	California
United States	Forest Investigative Site	Walnut Creek	California
United States	Forest Investigative Site	Woodstock	Vermont
United States	Forest Investigative Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Change (PGIC) Responder Rate at End of Study	The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.	End of Randomized treatment period (11 weeks)	No
Secondary	Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study	The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).	Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)	No