Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease

Treatments: Drug: Ropinirole XL (formerly CR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650104

101468/196

Details and patient eligibility

About

The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.

Enrollment: 76 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or non-pregnant/non-breast feeding females
• At least 30 years of age
• Diagnosis of idiopathic Parkinson''s disease (Hoehn & Yahr criteria)
• Completed either Study 167 or Study 164

Exclusion criteria

• Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
• Dizziness or fainting due to orthostatic hypotension on standing
• Significant sleep disorder
• Drug abuse or alcoholism

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Active

Active Comparator group

Description:

Open label medication - Ropinirole CR

Treatment:

Drug: Ropinirole XL (formerly CR)