Parkinson's Disease
Conditions
Interventions
investigational material(s)
Generic name etc : ReQuip Tablet
INN of investigational material :
Therapeutic category code : 116 Antiperkinsonism agents
Dosage and Administration for Investigational ma
Sponsors
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: - Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn & Yahr Stages I to IV. - Patients who have been receiving another dopamine agonist for at least 4 weeks prior to the start of the screening phase and are expected to benefit from conversion to ReQuip. - Age: >=20 years (at the time of written informed consent). Main exclusion criteria: - Patients who present with any serious medical condition other than PD (e.g., cardiac, hepatic or renal disorder or hematopoietic disorder). - Patients with postural hypotension with any subjective symptoms (e.g., dizziness and syncope). - Patients who have had any serious psychiatric symptoms (e.g., confusion, hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD drugs) within 6 months (26 weeks) prior to written informed consent.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adjunct Therapy Group (ReQuip+L-dopa) Change from baseline in Japanese UPDRS Part III total score (recorded in an "on" state) Monotherapy Group (ReQuip alone) Change from baseline in Japanese UPDRS Part III total score | — |
Outcome results
None listed