MedTrace Logo

Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population

NCT01418651 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-08-17

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

DRUG

Savella

milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Banner Health

    lead OTHER

Principal Investigators

  • Sandra Jacobson, MD · Banner Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418651 on ClinicalTrials.gov