Adolescent Fibromyalgia Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: placebo
* Drug: pregabalin (Lyrica)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* matching placebo capsules twice daily.<br>|
| Experimental: drug-pregabalin<br> | Drug: pregabalin (Lyrica)<br>* 75-450mg/day pregabalin dose optimised at start of study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep. | Week 15 | 
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). | Baseline to Week 15 | 
| Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep. | Baseline to Week 15 | 
| Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) | The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week. | Week 15 | 
| Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 | At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). | Week 15 | 
| Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 | At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). | Week 15 | 
| Proportion of Patient Global Impression Change (PGIC) at Week 15 | Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse). | Week 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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juvenile primary fibromyalgia syndrome, pediatric fibromyalgia, pregabalin, and Lyrica