Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
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.
|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|
- 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
- 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.
|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)|
milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)
|United States, Arizona|
|Banner Sun Health Research Institute|
|Sun City, Arizona, United States, 85351|
|Principal Investigator:||Sandra Jacobson, MD||Banner Sun Health Research Institute|