Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson Disease
Intervention: Pramipexole (Drug); Bromocriptine (Drug); Placebo pramipexole (Drug); Placebo bromocriptine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Boehringer Ingelheim
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).
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: Changes from baseline in sores of individual items on UPDRS Part IIChanges 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)
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 1999
Last updated: June 20, 2014
|