Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population

NCT01418651 | Terminated Phase 3

• 1 other identifier: 10-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. The investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older

  Percent change in self-reported severity of pain (averaged Visual Analog Scale scores) over 12 weeks of treatment. Rate of occurrence of adverse events necessitating drug discontinuation

  14 months

Secondary Outcomes (1)

• Determine the effects of milnacipran on cognition

  14 months

Study Arms (1)

Milnacipran

EXPERIMENTAL

Drug

Drug: Savella

Interventions

Savella DRUG

milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)

Milnacipran

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female patients.
• Age 65 years or older.
• Fibromyalgia diagnosed according to ACR 1990 criteria.
• Pain Score ≥ 10 on Gracely scale at screening and baseline assessments.
• Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation.

You may not qualify if:

• Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations.
• Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations.
• Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI.
• Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (\> 450 msec).
• Uncontrolled narrow angle glaucoma.
• History of seizures.
• Use of MAO inhibitor drugs within the last 14 days.
• Abnormal baseline liver or renal function tests.
• Dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol.
• Obstructive uropathy in males.

Sponsors & Collaborators

• Banner Health: lead
• Forest Laboratories: collaborator

Study Sites (1)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sandra Jacobson, MD

  Banner Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: August 17, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 17, 2011

Record last verified: 2011-01

Locations

US (1)