Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pramipexole
Bromocriptine
Placebo pramipexole
Placebo bromocriptine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Pramipexole
Bromocriptine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
Change from baseline in total score of UPDRS Part III (Motor Examination)
Secondary Outcome Measures
Changes from baseline in sores of individual items on UPDRS Part II
Changes from baseline in scores of individual items on UPDRS Part III
Change from baseline in area under the curve (AUC) in the UPDRS Part II score
Change from baseline in area under the curve (AUC) in the UPDRS Part III score
Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)
Change from baseline in total score of UPDRS Part IV (complications of therapy)
Change from baseline in total score of UPDRS Part I-III
Change from baseline in total score of UPDRS Part I-IV
Change from baseline in Modified Hoehn & Yahr stage
Clinical global impression of efficacy
Number of patients with adverse events
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Number of patients with abnormal changes in laboratory parameters
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02172573
Brief Title
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
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pramipexole
Arm Type
Experimental
Arm Title
Bromocriptine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pramipexole
Intervention Type
Drug
Intervention Name(s)
Bromocriptine
Intervention Type
Drug
Intervention Name(s)
Placebo pramipexole
Intervention Type
Drug
Intervention Name(s)
Placebo bromocriptine
Primary Outcome Measure Information:
Title
Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
Time Frame
Baseline and week 12
Title
Change from baseline in total score of UPDRS Part III (Motor Examination)
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Changes from baseline in sores of individual items on UPDRS Part II
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Changes from baseline in scores of individual items on UPDRS Part III
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Change from baseline in area under the curve (AUC) in the UPDRS Part II score
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Change from baseline in area under the curve (AUC) in the UPDRS Part III score
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Change from baseline in total score of UPDRS Part IV (complications of therapy)
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Change from baseline in total score of UPDRS Part I-III
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Change from baseline in total score of UPDRS Part I-IV
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Change from baseline in Modified Hoehn & Yahr stage
Time Frame
Baseline and weeks 2, 4, 6, 8, 10, 12
Title
Clinical global impression of efficacy
Time Frame
week 12
Title
Number of patients with adverse events
Time Frame
up to 16 weeks
Title
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time Frame
up to 12 weeks
Title
Number of patients with abnormal changes in laboratory parameters
Time Frame
up to 12 weeks
Title
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.505.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.505_literature.pdf
Description
Related Info
Learn more about this trial
Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease
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