Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.

• ClinicalTrials.gov Identifier: NCT03905486
• Recruitment Status: Completed
• First Posted: April 5, 2019
• Last Update Posted: January 7, 2020
• Sponsor: Yousra Hisham Abdel Fattah
• Information provided by (Responsible Party): Yousra Hisham Abdel Fattah, University of Alexandria

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 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
• Actual Primary Completion Date: November 30, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

Alexandria University, Faculty of Medicine

Alexandria, Egypt, 00123

Sponsors and Collaborators

Yousra Hisham Abdel Fattah

Investigators

• Principal Investigator: Yousra H Abdel-Fattah; Alexandria University Faculty of Medicine

More Information

• Responsible Party: Yousra Hisham Abdel Fattah, Principle investigator, University of Alexandria
• ClinicalTrials.gov Identifier: NCT03905486
• Other Study ID Numbers: 0303417
• First Posted: April 5, 2019
• Last Update Posted: January 7, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pregabalin; 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