Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00797797

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 III

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

Drug Information available for: Milnacipran hydrochloride Milnacipran Pregabalin

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 February 09, 2012