Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia - Full Text View

Purpose

The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Condition	Intervention	Phase
Fibromyalgia	Drug: Placebo Drug: Milnacipran	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Fibromyalgia

Drug Information available for: Milnacipran Milnacipran hydrochloride

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Time to Loss of Therapeutic Response (LTR) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment

Secondary Outcome Measures:

Time to Worsening in Patient Global Impression of Change (PGIC) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. 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.
Time to Worsening in Multidimensional Assessment of Fatigue (MAF) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).

Enrollment:	340
Study Start Date:	November 2009
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo tablets administered orally twice daily	Drug: Placebo Placebo tablets administered orally twice daily
Experimental: 2 Milnacipran tablets administered orally twice daily	Drug: Milnacipran Milnacipran tablets administered orally twice daily Other Name: Savella ®

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Currently participating in Study MLN-MD-06
Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria:

Significant risk of suicide
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 12 months
Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
Active liver disease
Severe renal impairment
Platelet and bleeding disorders
Female patients who are pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014585

Show 58 Study Locations

Sponsors and Collaborators

Forest Laboratories

Cypress Bioscience, Inc.

Investigators

Study Director:

Joel Trugman, MD

Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc

More Information

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01014585 History of Changes
Other Study ID Numbers:	MLN-MD-27
Study First Received:	November 13, 2009
Results First Received:	June 7, 2011
Last Updated:	September 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Milnacipran
Pain
Durability of Effect
Loss of Therapeutic Response

Fatigue
Forest Research Institute
Savella ®

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
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

ClinicalTrials.gov processed this record on May 16, 2013