Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

Study Overview
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Brief Summary
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Diagnosis of fibromyalgia is complex and treatment options are limited. Pharmacological management of fibromyalgia is mainly centered on the central nervous system. In particular there is robust evidence for the use of tricyclic antidepressants (e.g., amitriptyline), anti-convulsants such as gabapentin or pregabalin and agents from the serotonin norepinephrine reuptake inhibitor (SNRI) family such as milnacipran. Aim of the work: To compare the efficacy of pregabalin agent (averopreg) alone versus combined pregabalin and serotonin norepinephrine reuptake inhibitor (milnacipran) in the management of fibromyalgia.

Detailed Description
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Subjects: The study will include 50 patients diagnosed as having fibromyalgia according to the ACR 2010 Fibromyalgia diagnostic criteria. Methods: Patients will be classified into two groups: 1) Group 1: Patients will receive pregabalin as a monotherapy and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week based on efficacy and tolerability. 7) Group 2: Patients will receive combined pregabalin and milnacipran and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week for the pregabalin and starting by 12.5 mg increasing gradually to reach 100 mg daily of milnacipran based on efficacy and tolerability.

Official Title
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The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia.

Conditions
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Fibromyalgia, Primary

Intervention / Treatment
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* Drug: Pregabalin 300mg
* Drug: Combined pregabalin 300mg and milancipran 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criteria Exclusion Criteria: Patients with major medical disorders or uncontrolled medical conditions Patients with recent myocardial infarction or stroke, Patients with active liver disease, Patients with renal impairment (creatinine clearance < 60 ml/min), Patients with documented autoimmune disease, Patients with severe chronic obstructive pulmonary disease, Patients with unstable diabetes, pregnancy or breastfeeding patients Patients with exposed to any investigational drug within the past 6 months

Ages Eligible for Study
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Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G1: patients will receive pregabalin<br>pregabalin as a mono-therapy will be administered in increment doses for 3 months | Drug: Pregabalin 300mg<br>* Group 1: will receive pregabalin as a monotherapy. Pregabalin will be administered according to the treatment recommendations for fibromyalgia in the package insert [Pfizer Inc., 2012] starting by 50 mg twice daily increasing to 300 mg twice daily according to the efficacy and tolerability for 3 months.<br>|
| Active Comparator: G2: patients will receive pregabalin and milnacipran<br>pregabalin and milancipran as a combination therapy will be administered in increment doses for 3 months | Drug: Combined pregabalin 300mg and milancipran 100mg<br>* Group 2: will receive a combined pregabalin and milancipran. Pregabalin will be administered as group 1, while milancipran will be administered according to the treatment recommendations for fibromyalgia, starting by 50 mg once daily for 1 week then increased to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibromyalgia impact questionnaire (FIQ) | assesses the overall functional ability and the impact of fibromyalgia on the patients life, with a range from 0-100, 0 indicating no functional impairment or effect of the disease on the patients life and 100 indicating a very bad and tremendous effect of fibromyalgia on the patients life | 3 months | 
| visual analogue scale (VAS) for pain | assesses the overall pain of fibromyalgia on a 100 mm pain scale with 0 indicating no pain and 100 indicating the worst pain ever | 3 months | 

Secondary Outcome Measures

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