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Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

Fibromyalgia, Primary Clinical Trial

Official title:
The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia.

Clinical Trial 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.

Clinical Trial Description

Subjects: The study will include 50 patients diagnosed as having fibromyalgia according to the ACR 2010 Fibromyalgia diagnostic criteria.

Methods: Patients will be classified into two groups:

1) Group 1: Patients will receive pregabalin as a monotherapy and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week based on efficacy and tolerability.

7) Group 2: Patients will receive combined pregabalin and milnacipran and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week for the pregabalin and starting by 12.5 mg increasing gradually to reach 100 mg daily of milnacipran based on efficacy and tolerability. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03905486
Study type Interventional
Source University of Alexandria
Contact
Status Completed
Phase N/A
Start date April 1, 2019
Completion date December 31, 2019
View Details
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