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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

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT02172573

First Posted

June 20, 2014

Last Updated

June 20, 2014

Sponsor

Boehringer Ingelheim

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