An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151528

Enrollment

428

Registered

2005-09-09

Start date

2005-01-31

Completion date

2006-06-30

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.

Interventions

DRUGPregabalin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056 * Must 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 A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

Design outcomes

Primary

Measure	Time frame
Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.	—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026