Adolescent Fibromyalgia Study


Last updated date
Study Location
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of fibromyalgia

- 12-17 years of age

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with other pain conditions

- Previous treatment with pregabalin

- Patients taking excluded medication


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Advanced Information
Descriptive Information
Brief Title  ICMJE Adolescent Fibromyalgia Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: placebo
    matching placebo capsules twice daily.
  • Drug: pregabalin (Lyrica)
    75-450mg/day pregabalin dose optimised at start of study
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: drug-pregabalin
    Intervention: Drug: pregabalin (Lyrica)
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2009)
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   India,   Taiwan,   United States
Removed Location Countries Czech Republic
Administrative Information
NCT Number  ICMJE NCT01020474
Other Study ID Numbers  ICMJE A0081180
2010-019521-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer Call CenterPfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP