Clinical trial NCT01020474: Adolescent Fibromyalgia Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: juvenile primary fibromyalgia syndrome
pediatric fibromyalgia
pregabalin
and Lyrica
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 107
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Week 15 in Mean Pain Diary Score
timeFrame: Week 15
Secondary outcomes:
measure: Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
timeFrame: Week 15
measure: Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
timeFrame: Baseline to Week 15
measure: Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
timeFrame: Baseline to Week 15
measure: Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
timeFrame: Week 15
measure: Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
timeFrame: Week 15
measure: Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
timeFrame: Week 15
measure: Proportion of Patient Global Impression Change (PGIC) at Week 15
timeFrame: Week 15
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Delray Beach
country: United States
facility: Eileen Messing, Psy D.
state: Florida
city: Delray Beach
country: United States
facility: Arthritis Associates of South Florida
state: Florida
city: Delray Beach
country: United States
facility: Delray Research Associates
state: Florida
city: Miami
country: United States
facility: Florida Medical Center and Research, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research, Incorporated
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Columbus
country: United States
facility: Medical Research & Health Education Foundation, Inc.
state: Georgia
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology, PC
state: Georgia
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit
state: Kentucky
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: University Pediatric Rheumatology of Kentucky, LLC
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center Department of Pediatrics
state: Massachusetts
city: Saint Louis
country: United States
facility: A&A Pain Institute of St. Louis
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Duke Medicine Plaza
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Boardman
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Boardman
country: United States
facility: Boardman Medical Pavilion
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Research Institute at Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children / Section of Rheumatology
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Pediatric Rheumatology
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: MUSC University Children's Hospital
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Research Center
state: South Carolina
city: Salt Lake City
country: United States
facility: Fatigue Consultation Clinic
state: Utah
city: Ricany
country: Czechia
facility: Bioregeneracni a rehabilitacni centrum
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences Ltd
state: Andhra Pradesh
city: Mangalore
country: India
facility: Mallikatta Neuro Centre
state: Karnataka
city: Nagpur
country: India
facility: Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
state: Maharashtra
city: Lucknow
country: India
facility: Department of Physical Medicine & Rehabilitation
state: Uttar Pradesh
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.