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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01418651
• Date of registration: 28/03/2011
• Primary sponsor: Banner Health
• Public title: Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
• Scientific title: Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
• Date of first enrolment: March 2011
• Target sample size: 20
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01418651
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Sandra Jacobson, MD
• Affiliation: Banner Sun Health Research Institute

Key inclusion & exclusion 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.



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Fibromyalgia

Intervention(s)

Drug: Savella

Primary Outcome(s)

Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older [Time Frame: 14 months]

Secondary Outcome(s)

Determine the effects of milnacipran on cognition [Time Frame: 14 months]

Secondary ID(s)

10-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories