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Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00797797
First received: November 24, 2008
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Fibromyalgia
 Drug: No Treatment Added
Drug: Milnacipran Added
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Patient Global Impression of Change (PGIC) Responder Rate at End of Study [ Time Frame: End of Randomized treatment period (11 weeks) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 364
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milnacipran Added Drug: Milnacipran Added
Milnacipran 100 mg/d added
Experimental: No Treatment Added Drug: No Treatment Added
No added treatment
Other Name: Lyrica (r)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797797

  Show 60 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Patricia D'Astoli Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)
ClinicalTrials.gov Identifier: NCT00797797     History of Changes
Other Study ID Numbers: MLN-MD-15
Study First Received: November 24, 2008
Results First Received: November 18, 2010
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
fibromyalgia
milnacipran
pregabalin
treatment
Forest Research Institute

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Pregabalin
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013