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Completed

NCT Number: NCT00797797

Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Treatment Added

Drug

No added treatment

Other names: Lyrica (r)

Milnacipran Added

Drug

Milnacipran 100 mg/d added

Primary outcomes

  1. Patient Global Impression of Change (PGIC) Responder Rate at End of Study

    Time frame: End of Randomized treatment period (11 weeks)

    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.

Secondary outcomes

  1. Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study

    Time frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)

    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).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 25, 2008
Registry last updated
Feb 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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