Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

NCT03905486 | Completed

• 1 other identifier: 0303417
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia, Primary

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Leeds sleep evaluation questionnaire

  3 months

Study Arms (2)

G1: patients will receive pregabalin

ACTIVE COMPARATOR

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

Drug: Pregabalin 300mg

G2: patients will receive pregabalin and milnacipran

ACTIVE COMPARATOR

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

Drug: Combined pregabalin 300mg and milancipran 100mg

Interventions

Pregabalin 300mg 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.

G1: patients will receive pregabalin

Combined pregabalin 300mg and milancipran 100mg 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.

G2: patients will receive pregabalin and milnacipran

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients
• diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Yousra Hisham Abdel Fattah: lead

Study Sites (1)

Alexandria University, Faculty of Medicine

Alexandria, 00123, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yousra H Abdel-Fattah

  Alexandria University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 5, 2019
• Study Start: April 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)