Effect of Milnacipran / Gabapentin in Fibromyalgia

Mansoura University

Status: Unknown

Conditions: Fibromyalgia

Treatments: Drug: Gabapentin; Drug: Milnacipran; Drug: Combined gabapentin/milnacipran

Study type: Interventional

Funder types: Other

Identifiers

NCT05384210

MFM-IRB، MD.21.12.577

Details and patient eligibility

About

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.

Full description

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

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• There are no other criteria rather than age and sex

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Milnacipran

Active Comparator group

Description:

Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months

Treatment:

Drug: Milnacipran

Gabapentin

Active Comparator group

Description:

patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months

Treatment:

Drug: Gabapentin

Combined gabapentin/milnacipran

Active Comparator group

Description:

Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months

Treatment:

Drug: Combined gabapentin/milnacipran