Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease
Phase 3
Completed
- Conditions
- Parkinson Disease
- Interventions
- Registration Number
- NCT02172573
- Lead Sponsor
- Boehringer Ingelheim
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pramipexole Pramipexole - Placebo Placebo pramipexole - Placebo Placebo bromocriptine - Bromocriptine Bromocriptine -
- Primary Outcome Measures
Name Time Method Change from baseline in total score of UPDRS Part III (Motor Examination) Baseline and week 12 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
- Secondary Outcome Measures
Name Time Method Changes from baseline in scores of individual items on UPDRS Part III Baseline and weeks 2, 4, 6, 8, 10, 12 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 Changes from baseline in sores of individual items on UPDRS Part II 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-IV Baseline and weeks 2, 4, 6, 8, 10, 12 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 Modified Hoehn & Yahr stage 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 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-III Baseline and weeks 2, 4, 6, 8, 10, 12