Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
This study has been terminated.
(Lack of subjects)
Information provided by:
First received: March 28, 2011
Last updated: August 16, 2011
Last verified: January 2011
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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)
|Ages Eligible for Study:
||65 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01418651
|Banner Sun Health Research Institute
|Sun City, Arizona, United States, 85351 |
||Sandra Jacobson, MD
||Sandra Jacobson MD - Research Physician, Banner Sun Health Research Inst.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2011
||August 16, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 29, 2016
Myofascial Pain Syndromes
Nervous System Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors