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Trial record 46 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

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ClinicalTrials.gov Identifier: NCT03905486
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Yousra Hisham Abdel Fattah, University of Alexandria

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia, Primary Drug: Pregabalin 300mg Drug: Combined pregabalin 300mg and milancipran 100mg Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia.
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: G1: patients will receive pregabalin
pregabalin as a mono-therapy will be administered in increment doses for 3 months
Drug: 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.

Active Comparator: G2: patients will receive pregabalin and milnacipran
pregabalin and milancipran as a combination therapy will be administered in increment doses for 3 months
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905486


Contacts
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Contact: Yousra Hisham H Abdel-Fattah +20127320303 yousrahisham@gmail.com
Contact: Rehab A Elnemr +201006500715 hobaelnemr@hotmail.com

Locations
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Egypt
Alexandria University, Faculty of Medicine Recruiting
Alexandria, Egypt, 00123
Contact: Yousra H Abdel-Fattah    127320303    yousrahisham@gmail.com   
Sponsors and Collaborators
Yousra Hisham Abdel Fattah
Investigators
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Principal Investigator: Yousra H Abdel-Fattah Alexandria University Faculty of Medicine

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Responsible Party: Yousra Hisham Abdel Fattah, Principle investigator, University of Alexandria
ClinicalTrials.gov Identifier: NCT03905486     History of Changes
Other Study ID Numbers: 0303417
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Nervous System Diseases
Pregabalin
Milnacipran
Levomilnacipran
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Analgesics, Non-Narcotic
Antidepressive Agents