Adolescent Fibromyalgia Study

A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia

This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: placebo; Drug: pregabalin (Lyrica)

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Ricany, Czechia, 25101
    • Bioregeneracni a rehabilitacni centrum
• India
  • Andhra Pradesh
    • Secunderabad, Andhra Pradesh, India, 500 003
      • Krishna Institute of medical sciences Ltd
  • Karnataka
    • Mangalore, Karnataka, India, 575002
      • Mallikatta Neuro Centre
  • Maharashtra
    • Nagpur, Maharashtra, India, 440010
      • Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226 018
      • Department of Physical Medicine & Rehabilitation
• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Childrens Hospital Los Angeles
    • Santa Ana, California, United States, 92705
      • Apex Research Institute
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Arthritis Associates of South Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Research Associates
    • Delray Beach, Florida, United States, 33446
      • Eileen Messing, Psy D.
    • Miami, Florida, United States, 33142
      • Florida Medical Center and Research, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Harmony Clinical Research, Incorporated
    • Orlando, Florida, United States, 32806
      • Rheumatology Associates of Central Florida, PA
  • Georgia
    • Columbus, Georgia, United States, 31909
      • Medical Research & Health Education Foundation, Inc.
    • Lawrenceville, Georgia, United States, 30045
      • North Georgia Rheumatology, PC
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
    • Louisville, Kentucky, United States, 40202
      • Kosair Children's Hospital
    • Louisville, Kentucky, United States, 40202
      • Kosair Charities Pediatric Clinical Research Unit
    • Louisville, Kentucky, United States, 40202
      • University Pediatric Rheumatology of Kentucky, LLC
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center Department of Pediatrics
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • A&A Pain Institute of St. Louis
  • North Carolina
    • Durham, North Carolina, United States, 27717
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27609
      • Duke Medicine Plaza
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital
    • Boardman, Ohio, United States, 44512
      • Akron Children's Hospital
    • Boardman, Ohio, United States, 44512
      • Boardman Medical Pavilion
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
    • Columbus, Ohio, United States, 43205
      • The Research Institute at Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134-1095
      • St. Christopher's Hospital for Children / Section of Rheumatology
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina, Pediatric Rheumatology
    • Charleston, South Carolina, United States, 29425
      • MUSC University Children's Hospital
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Fatigue Consultation Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of fibromyalgia
• 12-17 years of age

Exclusion Criteria:

• Patients with other pain conditions
• Previous treatment with pregabalin
• Patients taking excluded medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; matching placebo capsules twice daily.
Experimental: drug-pregabalin	Drug: pregabalin (Lyrica); 75-450mg/day pregabalin dose optimised at start of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 15 in Mean Pain Diary Score	The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").	Week 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score	Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".	Week 15
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)	Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).	Baseline to Week 15
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)	Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".	Baseline to Week 15
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)	The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.	Week 15
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15	At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).	Week 15
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15	At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).	Week 15
Proportion of Patient Global Impression Change (PGIC) at Week 15	Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).	Week 15

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 23, 2009
• First Submitted That Met QC Criteria: November 23, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: pregabalin; juvenile primary fibromyalgia syndrome; pediatric fibromyalgia; and Lyrica
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081180; 2010-019521-34 (EudraCT Number)