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Completed

NCT Number: NCT03905486

Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

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.

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Key information

Conditions

Fibromyalgia, Primary Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of Medicine

Alexandria, 00123, Egypt

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. fibromyalgia impact questionnaire (FIQ)

    Time frame: 3 months

    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

  2. visual analogue scale (VAS) for pain

    Time frame: 3 months

    assesses the overall pain of fibromyalgia on a 100 mm pain scale with 0 indicating no pain and 100 indicating the worst pain ever

Secondary outcomes

  1. Leeds sleep evaluation questionnaire

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Yousra Hisham Abdel Fattah

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2019
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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