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

June 20, 2014 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
315

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: Baseline and week 12
Baseline and week 12
Change from baseline in total score of UPDRS Part III (Motor Examination)
Time Frame: Baseline and week 12
Baseline and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 12 weeks
up to 12 weeks
Number of patients with adverse events
Time Frame: up to 16 weeks
up to 16 weeks
Changes from baseline in sores of individual items on UPDRS Part II
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Changes from baseline in scores of individual items on UPDRS Part III
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part II score
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part III score
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part IV (complications of therapy)
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-III
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-IV
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in Modified Hoehn & Yahr stage
Time Frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Baseline and weeks 2, 4, 6, 8, 10, 12
Clinical global impression of efficacy
Time Frame: week 12
week 12
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time Frame: up to 12 weeks
up to 12 weeks
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2000

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 248.505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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