Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
|ClinicalTrials.gov Identifier: NCT01418651|
Recruitment Status : Terminated (Lack of subjects)
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Savella||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)
- Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older [ Time Frame: 14 months ]
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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418651
|United States, Arizona|
|Banner Sun Health Research Institute|
|Sun City, Arizona, United States, 85351|
|Principal Investigator:||Sandra Jacobson, MD||Banner Health|