Status:
TERMINATED
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
Lead Sponsor:
Banner Health
Collaborating Sponsors:
Forest Laboratories
Conditions:
Fibromyalgia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
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-t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01418651
Start Date
March 1 2011
End Date
August 1 2011
Last Update
August 17 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351