Clinical trial NCT03905486: Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.
Official title: The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia, Primary
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 58
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: fibromyalgia impact questionnaire (FIQ)
timeFrame: 3 months
measure: visual analogue scale (VAS) for pain
timeFrame: 3 months
Secondary outcomes:
measure: Leeds sleep evaluation questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of Medicine
Study officials:
affiliation: Alexandria University Faculty of Medicine
name: Yousra H Abdel-Fattah
role: PRINCIPAL_INVESTIGATOR
References: