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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Pramipexole

Group Type EXPERIMENTAL

Pramipexole

Intervention Type DRUG

Bromocriptine

Group Type EXPERIMENTAL

Bromocriptine

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo pramipexole

Intervention Type DRUG

Placebo bromocriptine

Intervention Type DRUG

Interventions

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Pramipexole

Intervention Type DRUG

Bromocriptine

Intervention Type DRUG

Placebo pramipexole

Intervention Type DRUG

Placebo bromocriptine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No