Study of Milnacipran for the Treatment of Fibromyalgia

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Placebo; Drug: Milnacipran 100mg

• Registration Number: NCT00314249
• Lead Sponsor: Forest Laboratories

Brief Summary

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-13
• Primary Completion: 2008-06
• Results First Submitted: 2009-06-30
• Results First Submitted QC: 2009-09-25
• Results First Posted: 2009-11-01
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1025

Inclusion Criteria

• diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria

• psychiatric illness,
• depression,
• suicidal risk,
• substance abuse,
• pulmonary dysfunction,
• renal impairment,
• active cardiac disease,
• liver disease,
• autoimmune disease,
• cancer,
• inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, oral administration, twice daily for 12 weeks
Milnacipran	Milnacipran 100mg	Milnacipran 100mg/day (50mg BID \[twice a day\])

Primary Outcome Measures

Name	Time	Method
Composite Syndrome Responder Status	At the end of the three-month stable dose treatment phase	Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \[PED\], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
Composite Pain Responder Status	At the end of three-month stable dose treatment phase	Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \[PED\], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."

Secondary Outcome Measures

Name	Time	Method
Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase	Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)	Time-weighted average (area under the curve \[AUC\]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.; PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).
Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.	Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase	Time-weighted average (area under the curve \[AUC\]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.; PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse.
Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.	Baseline through end of week 12 (Visit TX12)	Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.; MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1="yes, that is true" and 5="no, that is not true."
Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12	Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase	Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains \& 2 component summaries (mental and physical); assessing quality of life, health \& functional status.; SF-36 PCS: weighted summary of physical function using all 8 domains.; Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.; SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 Virginia Beach, Virginia, United States