The purpose of this study is to evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
30 mg to 120 mg administered orally, daily for 12 weeks
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rate of enrollment
Time frame: 6 months of enrollment
Rate of retention
Time frame: 12 weeks of treatment
Change in score from baseline to endpoint on the Pediatric Pain Questionnaire (PPQ)
Time frame: Baseline, 12 weeks
Change in score from baseline to endpoint on the Brief Pain Inventory (BPI) modified short form severity
Time frame: Baseline, 12 weeks
Change in score from baseline to endpoint on the Clinical Global Impression of Severity, overall (CGI-Severity: overall) scale
Time frame: Baseline, 12 weeks
Endpoint score of Patient Global Impression of Improvement (PGI-I) scale
Time frame: 12 weeks
Change in score from baseline to endpoint on the Functional Disability Inventory - child version (FDI-child) scale
Time frame: Baseline, 12 weeks
Change in score from baseline to endpoint on the Functional Disability Inventory - parent version (FDI-parent) scale
Time frame: Baseline, 12 weeks
Change in score from baseline to endpoint on the Clinical Global Impression of Severity for Mental Illness (CGI-mental illness) scale
Time frame: Baseline, 12 weeks
Change in score from baseline to endpoint on the Children's Depression Inventory (CDI)
Time frame: Baseline, 12 weeks
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Phoenix, Arizona, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fairfield, Connecticut, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis, Missouri, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Staten Island, New York, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Canton, Ohio, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cincinnati, Ohio, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Oklahoma City, Oklahoma, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Portland, Oregon, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Salt Lake City, Utah, United States
Change in score from baseline to endpoint on the Multidimensional Anxiety Scale for Children (MASC)
Time frame: Baseline, 12 weeks
Columbia Suicide-Severity Rating Scale (CSSRS)
Time frame: During 12 weeks of treatment
Change in score from baseline to endpoint on the Pediatric Quality of Life Inventory - teen report (PedsQL)
Time frame: Baseline, 12 weeks
Number of patients with treatment emergent abnormal laboratory values
Time frame: During 12 weeks of treatment
Change from baseline to endpoint in blood pressure
Time frame: Baseline, 12 weeks
Change from baseline to endpoint in heart rate
Time frame: Baseline, 12 weeks
Change from baseline to endpoint in weight
Time frame: Baseline, 12 weeks
Change from baseline to endpoint in height
Time frame: Baseline, 12 weeks
Number of patients with treatment emergent abnormal electrocardiogram
Time frame: During 12 weeks of treatment