Pregabalin In Adolescent Patients With Fibromyalgia

Viatris

Status and phase: Completed; Phase 4

Conditions: Fibromyalgia

Treatments: Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01020526

A0081231

2010-020300-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

63 participants in 1 patient group

Pregabalin

Experimental group

Treatment:

Drug: pregabalin