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Effect of Milnacipran / Gabapentin in Fibromyalgia

NCT05384210 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-05-20

No results posted yet for this 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.

Conditions

  • Fibromyalgia

Interventions

DRUG

Milnacipran

Milnacipran will be administered according to the treatment recommendations for fibromyalgia, starting with 50 mg once daily for 1 week then increasing to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 months.

DRUG

Gabapentin

Patients will receive gabapentin (1200 mg twice daily) as a monotherapy. Gabapentin will be administered according to the treatment recommendations for FM patients starting with 400 mg 3 times per day, then increasing the dose to 800 mg 3 times per day with a maximum dose of 2400 mg per day according to efficacy and tolerability for 3 months

DRUG

Combined gabapentin/milnacipran

Patients will receive combined gabapentin as group B and MLN as group A

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Amr M Yassin, MD · Professor of Anesthesia and Surgical Intensive Care

  • Eiad A Ramzy, md · Assistant Professor of Anesthesia and Surgical Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-10-31
Completion
2023-11-30

Countries

  • Egypt

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 NCT05384210 on ClinicalTrials.gov