Pregabalin In Adolescent Patients With Fibromyalgia

Completed · Phase 4

Conditions studied: Fibromyalgia

In brief

The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin

Key facts

Study ID

NCT01020526

Run by

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

People needed

63

Starts

2010-09-01

Expected to finish

2015-06-01

Last updated by the study team

2021-01-28

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

You may not qualify if…

• Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Florida Medical Center & Research — Miami, Florida, United States
• Harmony Clinical Research, Incorporated — North Miami Beach, Florida, United States
• Rheumatology Associates of Central Florida, PA — Orlando, Florida, United States
• Medical Research & Health Education Foundation, Inc. — Columbus, Georgia, United States
• Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• University Pediatric Rheumatology of Kentucky, LLC — Louisville, Kentucky, United States
• University of Massachusetts Memorial Medical Center Department of Pediatrics — Worcester, Massachusetts, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Akron Children's Hospital-Mahoning Valley — Boardman, Ohio, United States
• Akron Children's Hospital — Boardman, Ohio, United States
• University of Cincinnati Department of Psychiatry and Behavioral Neuroscience — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• The Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• Medical University of South Carolina, Pediatric Rheumatology — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Carolina Research Center — Myrtle Beach, South Carolina, United States
• Fatigue Consultation Clinic — Salt Lake City, Utah, United States
• Bioregeneracni a rehabilitacni centrum — Říčany, Czechia
• Krishna Institute of Medical Sciences Ltd — Secunderabad, Andhra Pradesh, India
• Mallikatta Neuro Center — Mangalore, Karnataka, India
• Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics — Nagpur, Maharashtra, India

Full record on ClinicalTrials.gov

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