Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

Yousra Hisham Abdel Fattah

Status: Completed

Conditions: Fibromyalgia, Primary

Treatments: Drug: Combined pregabalin 300mg and milancipran 100mg; Drug: Pregabalin 300mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03905486

0303417

Details and patient eligibility

About

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.

Full description

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.

2. 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.

Enrollment: 58 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

G1: patients will receive pregabalin

Active Comparator group

Description:

pregabalin as a mono-therapy will be administered in increment doses for 3 months

Treatment:

Drug: Pregabalin 300mg

G2: patients will receive pregabalin and milnacipran

Active Comparator group

Description:

pregabalin and milancipran as a combination therapy will be administered in increment doses for 3 months

Treatment:

Drug: Combined pregabalin 300mg and milancipran 100mg