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Pramipexole in Parkinson's Disease (Hong Kong/Taiwan)
NCT02177357Phase 3
Key facts
- Status
- Completed
- Start
- Nov 1998
- Primary completion
- Jan 2000
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- pramipexole
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 3, randomised, double-blind trial in Parkinson's disease (PD) comparing Pramipexole with Placebo (2 arms). Primary endpoints: Change from baseline in the sum of the UPDRS (Unified Parkinson Disease Rating Scale) Parts II and III total scores at 15 weeks, Number of patients with clinically significant changes in vital signs at 15 weeks and 3 more. Started Nov 1998; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Pramipexole
Pramipexole escalation dose
Placebo
Placebo comparator
03
Who it enrols
Patients with idiopathic Parkinson disease (Stage 1-4), either untreated or on stable levodopa therapy. Excludes patients with dementia, psychosis, significant heart/liver/renal disease, or recent use of other dopamine agonists.
04
Endpoints
Primary
Change from baseline in the sum of the UPDRS (Unified Parkinson Disease Rating Scale) Parts II and III total scores
Number of patients with clinically significant changes in vital signs
Number of patients with abnormal changes in laboratory parameters
Number of patients with abnormal changes in 12-lead ECG
Number of patients with adverse events
Secondary
Change from baseline in the individual UPDRS Part II total score
Change from baseline in the individual UPDRS Part III total score
Change from baseline in the Modified Hoehn and Yahr Scale
Change from baseline in the number of 'off' hours in those patients who had been on levodopa therapy
Change from baseline in the Mini-Mental Status Examination
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