Effect of Milnacipran / Gabapentin in Fibromyalgia

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

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Milnacipran
* Drug: Gabapentin
* Drug: Combined gabapentin/milnacipran


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Milnacipran<br>Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months | Drug: Milnacipran<br>* 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.<br>|
| Active Comparator: Gabapentin<br>patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months | Drug: Gabapentin<br>* 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<br>|
| Active Comparator: Combined gabapentin/milnacipran<br>Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months | Drug: Combined gabapentin/milnacipran<br>* Patients will receive combined gabapentin as group B and MLN as group A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |