Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia - Full Text View

Purpose

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/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 Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Milnacipran Milnacipran hydrochloride Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) [ Time Frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. ] [ Designated as safety issue: No ]
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.

Secondary Outcome Measures:

Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score [ Time Frame: Change from Baseline (Week 3) to Visit 5 (Week 13) ] [ Designated as safety issue: No ]
The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).

Enrollment:	107
Study Start Date:	February 2010
Study Completion Date:	January 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo tablets, twice a day, oral administration	Drug: Placebo Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper. Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.
Experimental: Milnacipran Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.	Drug: Milnacipran Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper. Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period. Other Name: Savella

Arms

Assigned Interventions

Placebo Comparator: Placebo

Placebo tablets, twice a day, oral administration

Drug: Placebo

Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.

Experimental: Milnacipran

Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.

Drug: Milnacipran

Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.

Other Name: Savella

Detailed Description:

Two weeks Duloxetine 60 mg Open-Label Period
Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
One week Double-Blind Down-Taper Period

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
Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
Duloxetine must have been prescribed for the treatment of Fibromyalgia
Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.

Exclusion Criteria:

Suicidal risk
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 6 months
Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at Screening (Visit 1)
Substance abuse
Pulmonary dysfunction
Severe renal impairment
Active cardiac disease
Liver disease
Uncontrolled narrow-angle glaucoma
Autoimmune disease
Cancer
Inflammatory bowel disease
Unstable endocrine disease
Prostatic enlargement
Female patients who are pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077375

Show 26 Study Locations

Sponsors and Collaborators

Forest Laboratories

Cypress Bioscience, Inc.

Investigators

Study Director:

Allan Spera

Forest Research Institute Inc., A Subsidiary of Forest Laboratories

More Information

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01077375 History of Changes
Other Study ID Numbers:	MLN-MD-28
Study First Received:	February 25, 2010
Results First Received:	December 21, 2011
Last Updated:	December 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Milnacipran
Duloxetine
Switch
Forest Research Institute

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Duloxetine
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
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on May 19, 2013