Adolescent Fibromyalgia Study

NCT01020474 | Completed Phase 4 Results DMC

• 2 other identifiers: A00811802010-019521-34
• Study Type: interventional
• Target: 107
• Locations: 4 countries
• Sites: 36

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

juvenile primary fibromyalgia syndrome; pediatric fibromyalgia; pregabalin; and Lyrica

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change From Baseline to Week 15 in Mean Sleep Quality Diary Score

  Week 15

• Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)

  Baseline to Week 15

• Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)

  Baseline to Week 15

• Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)

  Week 15

• Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15

  Week 15

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: placebo

drug-pregabalin

EXPERIMENTAL

Drug: pregabalin (Lyrica)

Interventions

placebo DRUG

matching placebo capsules twice daily.

Placebo

pregabalin (Lyrica) DRUG

75-450mg/day pregabalin dose optimised at start of study

drug-pregabalin

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of fibromyalgia
• years of age

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (36)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Eileen Messing, Psy D.

Delray Beach, Florida, 33446, United States

Location

Arthritis Associates of South Florida

Delray Beach, Florida, 33484, United States

Location

Delray Research Associates

Delray Beach, Florida, 33484, United States

Location

Florida Medical Center and Research, Inc.

Miami, Florida, 33142, United States

Location

Harmony Clinical Research, Incorporated

North Miami Beach, Florida, 33162, United States

Location

Rheumatology Associates of Central Florida, PA

Orlando, Florida, 32806, United States

Location

Medical Research & Health Education Foundation, Inc.

Columbus, Georgia, 31909, United States

Location

North Georgia Rheumatology, PC

Lawrenceville, Georgia, 30045, United States

Location

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, 40202, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University Pediatric Rheumatology of Kentucky, LLC

Louisville, Kentucky, 40202, United States

Location

University of Massachusetts Memorial Medical Center Department of Pediatrics

Worcester, Massachusetts, 01655, United States

Location

A&A Pain Institute of St. Louis

St Louis, Missouri, 63141, United States

Location

Duke University Medical Center

Durham, North Carolina, 27717, United States

Location

Duke Medicine Plaza

Raleigh, North Carolina, 27609, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Akron Children's Hospital

Boardman, Ohio, 44512, United States

Location

Boardman Medical Pavilion

Boardman, Ohio, 44512, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

St. Christopher's Hospital for Children / Section of Rheumatology

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Medical University of South Carolina, Pediatric Rheumatology

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MUSC University Children's Hospital

Charleston, South Carolina, 29425, United States

Location

Carolina Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Fatigue Consultation Clinic

Salt Lake City, Utah, 84102, United States

Location

Bioregeneracni a rehabilitacni centrum

Říčany, 25101, Czechia

Location

Krishna Institute of Medical Sciences Ltd

Secunderabad, Andhra Pradesh, 500 003, India

Location

Mallikatta Neuro Centre

Mangalore, Karnataka, 575002, India

Location

Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics

Nagpur, Maharashtra, 440010, India

Location

Department of Physical Medicine & Rehabilitation

Lucknow, Uttar Pradesh, 226 018, India

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 27475753 DERIVED

Related Links

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

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: May 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 28, 2021
• Results First Posted: June 25, 2015

Record last verified: 2015-06

Locations

TW (1); US (30); IN (4); CZ (1)