Parkinson Disease
Conditions
Brief summary
The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).
Interventions
DRUGPramipexole
DRUGBromocriptine
DRUGPlacebo pramipexole
DRUGPlacebo bromocriptine
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism) * Patients who meet all of the following inclusion criteria * Patients who were at least 20 years of age * In- or outpatients of either sex * Patients in any stage on the modified Hoehn and Yahr scale * Patients being treated with L-dopa who have any of the following clinical conditions and problems * Patients with the wearing-off phenomenon * Patients with the on-off phenomenon * Patients to whom a sufficient amount of L-dopa cannot be administered owing to the occurrence of an adverse event * Patients in whom the effect of L-dopa is attenuated * Patients in whom a dose increase of L-dopa has been refrained * Patients with freezing phenomenon
Exclusion criteria
* Patients being treated with other dopamine agonists (bromocriptine, pergolide mesylate, talipexole hydrochloride). Patients who have been treated with other dopamine agonist for at least 4 weeks before the start of the study (the day of giving informed consent) are eligible for the study * Patients with a history of hypersensitivity to ergot preparations * Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour * Patients with subjective symptoms derived from orthostatic hypotension * Patients with hypotension (systolic blood pressure less than 100 mmHg) * Patients wiht Raynaud disease * Patients with peptic ulcer * Patients with complications such as severe cardiac, renal, hepatic disease etc. * Patients with a current or past history of epilepsy * Women who are or may be pregnant and lactating women * Patients who are receiving any other investigational products or who have received any other investigational product within 6 months of the study * Patients who are incompetent to give consent * Others judged by the investigator or co-investigator to be ineligible as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | Baseline and week 12 |
| Change from baseline in total score of UPDRS Part III (Motor Examination) | Baseline and week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in area under the curve (AUC) in the UPDRS Part II score | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Change from baseline in area under the curve (AUC) in the UPDRS Part III score | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood) | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Change from baseline in total score of UPDRS Part IV (complications of therapy) | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Change from baseline in total score of UPDRS Part I-III | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Change from baseline in total score of UPDRS Part I-IV | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Changes from baseline in sores of individual items on UPDRS Part II | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Clinical global impression of efficacy | week 12 |
| Number of patients with adverse events | up to 16 weeks |
| Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) | up to 12 weeks |
| Number of patients with abnormal changes in laboratory parameters | up to 12 weeks |
| Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) | up to 12 weeks |
| Change from baseline in Modified Hoehn & Yahr stage | Baseline and weeks 2, 4, 6, 8, 10, 12 |
| Changes from baseline in scores of individual items on UPDRS Part III | Baseline and weeks 2, 4, 6, 8, 10, 12 |
Outcome results
None listed