Effect of Milnacipran / Gabapentin in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05384210
• Other study ID #: MFM-IRB? MD.21.12.577
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 2022
• Est. completion date: November 2023

Study information

• Verified date: May 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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
• Combined gabapentin/milnacipran
Patients will receive combined gabapentin as group B and MLN as group A

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS) for pain	Assesses the overall pain of fibromyalgia on a 10 cm pain scale with 0 indicating no pain and 10 indicating the worst pain ever	3 months
Secondary	The Fibromyalgia Impact Questionnaire (FIQ).	Assesses the overall functional ability and the impact of fibromyalgia on the patient's life, with a range from 0-100, 0 indicating no functional impairment or effect of the disease on the patient's life and 100 indicating a very bad and tremendous effect of fibromyalgia on the patient's life.	3 months
Secondary	Leeds Sleep Evaluation Questionnaire	The four aspects of sleep around which the questionnaire is devised (Getting to sleep, GTS; Quality of sleep, QOS; Awakening from sleep, AFS; Behaviour following wakefulness, BFW), and assessing the effect of medication on the quality of sleep each question is a 100 mm line that the patient marks, 0 meaning very bad effect or worsening in sleep pattern, 50 meaning no improvement what so ever with no deterioration and 100 meaning excellent improvement in the sleep pattern	3 months