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

This study has been terminated.
(Lack of subjects)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Banner Health
ClinicalTrials.gov Identifier:
NCT01418651
First received: March 28, 2011
Last updated: August 16, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Savella
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study

Resource links provided by NLM:


Further study details as provided by Banner Health:

Primary Outcome Measures:
  • Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]

    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



Secondary Outcome Measures:
  • Determine the effects of milnacipran on cognition [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]

    Change in functional activity (FIQ), perceived health (SF-36), and severity of pain (Gracely scale).

    Incidence and severity of treatment-emergent adverse events. Change in sleep quality and daytime sleepiness as measured by the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.

    Change in other sleep/wake parameters(actigraphy measures). Change in cognitive test scores from baseline to the 12 week visit. Patient global impression of change score.



Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milnacipran
Drug
Drug: Savella
milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418651

Locations
United States, Arizona
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Sponsors and Collaborators
Banner Health
Forest Laboratories
Investigators
Principal Investigator: Sandra Jacobson, MD Banner Sun Health Research Institute
  More Information

No publications provided

Responsible Party: Sandra Jacobson MD - Research Physician, Banner Sun Health Research Inst.
ClinicalTrials.gov Identifier: NCT01418651     History of Changes
Other Study ID Numbers: 10-007
Study First Received: March 28, 2011
Last Updated: August 16, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014