Back to resultsEfficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Savella
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility 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.
Sites / Locations
- Banner Sun Health Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Milnacipran
Arm Description
Drug
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Determine the effects of milnacipran on cognition
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.
Full Information
NCT ID
NCT01418651
First Posted
March 28, 2011
Last Updated
August 16, 2011
Sponsor
Banner Health
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01418651
Brief Title
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
Official Title
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
Lack of subjects
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Banner Health
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Milnacipran
Arm Type
Experimental
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
Savella
Intervention Description
milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)
Primary Outcome Measure Information:
Title
Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older
Description
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
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Determine the effects of milnacipran on cognition
Description
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.
Time Frame
14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Jacobson, MD
Organizational Affiliation
Banner Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
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