Phase 4
Completed N=63
Pregabalin In Adolescent Patients With Fibromyalgia
Source: ClinicalTrials.gov NCT01020526 ↗Enrolled (actual)
63
Serious AEs
4.8%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline in Pain Numeric Rating Scale by Week — 6.7; -2.1; -1.8; -2.1 Number
◆ Published Evidence
Established
46citations · ~5 / year
Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study.
Summary
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
Linked Publications
-
Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Numeric Rating Scale by Week |
6.7; -2.1; -1.8; -2.1; -2.1; -2.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01020526) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.