NCT05384210

Effect of Milnacipran / Gabapentin in Fibromyalgia

Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2022-05-20
• Last updated: 2022-05-20

Locations

1 site across 1 country: Egypt