Clinical trial NCT02172573: Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease
Official title: A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 315
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
timeFrame: Baseline and week 12
measure: Change from baseline in total score of UPDRS Part III (Motor Examination)
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Changes from baseline in sores of individual items on UPDRS Part II
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Changes from baseline in scores of individual items on UPDRS Part III
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Change from baseline in area under the curve (AUC) in the UPDRS Part II score
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Change from baseline in area under the curve (AUC) in the UPDRS Part III score
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Change from baseline in total score of UPDRS Part IV (complications of therapy)
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Change from baseline in total score of UPDRS Part I-III
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Change from baseline in total score of UPDRS Part I-IV
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Change from baseline in Modified Hoehn & Yahr stage
timeFrame: Baseline and weeks 2, 4, 6, 8, 10, 12
measure: Clinical global impression of efficacy
timeFrame: week 12
measure: Number of patients with adverse events
timeFrame: up to 16 weeks
measure: Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
timeFrame: up to 12 weeks
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: up to 12 weeks
measure: Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
timeFrame: up to 12 weeks
Other outcomes:
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