Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Diagnosis of fibromyalgia is complex and treatment options are limited. Pharmacological management of fibromyalgia is mainly centered on the central nervous system. In particular there is robust evidence for the use of tricyclic antidepressants (e.g., amitriptyline), anti-convulsants such as gabapentin or pregabalin and agents from the serotonin norepinephrine reuptake inhibitor (SNRI) family such as milnacipran. Aim of the work: To compare the efficacy of pregabalin agent (averopreg) alone versus combined pregabalin and serotonin norepinephrine reuptake inhibitor (milnacipran) in the management of fibromyalgia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yousra Hisham Abdel Fattah
• Treatments: Levomilnacipran; Milnacipran; Pregabalin

Criteria

Inclusion Criteria:

• female patients

• diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criteria

Exclusion Criteria:

• Patients with major medical disorders or uncontrolled medical conditions

• Patients with recent myocardial infarction or stroke,

• Patients with active liver disease,

• Patients with renal impairment (creatinine clearance < 60 ml/min),

• Patients with documented autoimmune disease,

• Patients with severe chronic obstructive pulmonary disease,

• Patients with unstable diabetes,

• pregnancy or breastfeeding patients

• Patients with exposed to any investigational drug within the past 6 months