Effect of Milnacipran / Gabapentin in Fibromyalgia

NCT05384210 | Unknown DMC

• 1 other identifier: MFM-IRB، MD.21.12.577
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Fibromyalgia Impact Questionnaire (FIQ).

  3 months

• Leeds Sleep Evaluation Questionnaire

  3 months

Study Arms (3)

Milnacipran

ACTIVE COMPARATOR

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

Drug: Milnacipran

Gabapentin

ACTIVE COMPARATOR

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

Drug: Gabapentin

Combined gabapentin/milnacipran

ACTIVE COMPARATOR

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

Drug: Combined gabapentin/milnacipran

Interventions

Milnacipran DRUG

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.

Milnacipran

Gabapentin DRUG

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

Gabapentin

Combined gabapentin/milnacipran DRUG

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

Combined gabapentin/milnacipran

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• There are no other criteria rather than age and sex

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran; Gabapentin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Amr M Yassin, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Eiad A Ramzy, md

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: June 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completing the study and being accepted for publication.
• Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients.

Locations

EG (1)