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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172573
• Other study ID #: 248.505
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2014
• Last updated: June 20, 2014
• Start date: April 1999

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. primary completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pramipexole

• Bromocriptine

• Placebo pramipexole

• Placebo bromocriptine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change from baseline in total score of UPDRS Part III (Motor Examination)		Baseline and week 12	No
Secondary	Changes from baseline in sores of individual items on UPDRS Part II		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Changes from baseline in scores of individual items on UPDRS Part III		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Change from baseline in area under the curve (AUC) in the UPDRS Part II score		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Change from baseline in area under the curve (AUC) in the UPDRS Part III score		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Change from baseline in total score of UPDRS Part IV (complications of therapy)		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Change from baseline in total score of UPDRS Part I-III		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Change from baseline in total score of UPDRS Part I-IV		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Change from baseline in Modified Hoehn & Yahr stage		Baseline and weeks 2, 4, 6, 8, 10, 12	No
Secondary	Clinical global impression of efficacy		week 12	No
Secondary	Number of patients with adverse events		up to 16 weeks	No
Secondary	Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)		up to 12 weeks	No
Secondary	Number of patients with abnormal changes in laboratory parameters		up to 12 weeks	No
Secondary	Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)		up to 12 weeks	No

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