Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

NCT ID: NCT03905486

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-12-31

Brief Summary

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

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.

Conditions

Fibromyalgia, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G1: patients will receive pregabalin

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

Group Type: ACTIVE_COMPARATOR

Pregabalin 300mg

Intervention Type: DRUG

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.

G2: patients will receive pregabalin and milnacipran

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

Group Type: ACTIVE_COMPARATOR

Combined pregabalin 300mg and milancipran 100mg

Intervention Type: DRUG

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.

Interventions

Pregabalin 300mg

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.

Intervention Type: DRUG

Combined pregabalin 300mg and milancipran 100mg

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yousra Hisham Abdel Fattah

OTHER

Sponsor Role: lead

Responsible Party

Yousra Hisham Abdel Fattah

Principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yousra H Abdel-Fattah

Role: PRINCIPAL_INVESTIGATOR

Alexandria University Faculty of Medicine

Locations

Alexandria University, Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0303417

Identifier Type: -

Identifier Source: org_study_id