Effect of Milnacipran / Gabapentin in Fibromyalgia

Last updated: May 17, 2022
Sponsor: Mansoura University
Overall Status: Active - Enrolling

Phase

N/A

Condition

Fibromyalgia

Treatment

N/A

Clinical Study ID

NCT05384210
MFM-IRB، MD.21.12.577
  • Ages 18-70
  • Female

Study Summary

Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.

Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.

The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • There are no other criteria rather than age and sex

Exclusion

Exclusion Criteria:

  • Patient refusal.
  • Pregnancy or breastfeeding.
  • Active liver disease
  • Renal impairment (creatinine clearance < 60 mL/min).
  • Documented autoimmune disease.
  • Severe chronic obstructive pulmonary disease.
  • Recent arrhythmia
  • Myocardial infarction
  • Stroke.
  • Uncontrolled hypertension.
  • Glaucoma.

Study Design

Total Participants: 75
Study Start date:
June 01, 2022
Estimated Completion Date:
November 30, 2023

Study Description

The aim of the study is to evaluate the analgesic efficacy of gabapentin-MLN as combined or monotherapy on patients with FM.

Connect with a study center

  • Mansoura University

    Mansoura, DK 050
    Egypt

    Site Not Available

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