Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Pramipexole; Drug: Bromocriptine; Drug: Placebo pramipexole; Drug: Placebo bromocriptine

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo pramipexole; Drug: Placebo bromocriptine
Experimental: Pramipexole	Drug: Pramipexole
Experimental: Bromocriptine	Drug: Bromocriptine

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Number of patients with abnormal changes in laboratory parameters	up to 12 weeks
Number of patients with adverse events	up to 16 weeks
Changes from baseline in sores of individual items on UPDRS Part II	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
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
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 clinically significant changes in vital signs (blood pressure, pulse rate)	up to 12 weeks
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)	up to 12 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): July 1, 2000

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Dopamine Agonists; Dopamine Agents; Hormone Antagonists; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pramipexole; Bromocriptine
• Other Study ID Numbers: 248.505