Adolescent Fibromyalgia Study

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: placebo; Drug: pregabalin (Lyrica)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	107 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	May 2010
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo	Drug: placebo; matching placebo capsules twice daily.
Experimental: drug-pregabalin	Drug: pregabalin (Lyrica); 75-450mg/day pregabalin dose optimised at start of study

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline to Week 15 in Mean Pain Diary Score [ Time Frame: Week 15 ]
   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").

Secondary Outcome Measures :

1. Change From Baseline to Week 15 in Mean Sleep Quality Diary Score [ Time Frame: Week 15 ]
   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".
2. Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline to Week 15 ]
   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).
3. Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) [ Time Frame: Baseline to Week 15 ]
   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".
4. Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) [ Time Frame: Week 15 ]
   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.
5. Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: 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).
6. Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: 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).
7. Proportion of Patient Global Impression Change (PGIC) at Week 15 [ Time Frame: 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).

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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  Show 36 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01020474 History of Changes
Other Study ID Numbers:	A0081180; 2010-019521-34 ( EudraCT Number )
First Posted:	November 25, 2009
Results First Posted:	June 25, 2015
Last Update Posted:	June 25, 2015
Last Verified:	June 2015

Keywords provided by Pfizer:

juvenile primary fibromyalgia syndrome; pediatric fibromyalgia; pregabalin; and Lyrica

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pregabalin; Analgesics; Sensory System Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs