Pramipexole in Untreated and Levodopa-treated Parkinson's Disease Patients

June 26, 2014 updated by: Boehringer Ingelheim

Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study

The objectives of this study were to evaluate the efficacy, safety, and tolerability of pramipexole, as single-agent therapy or in combination with levodopa, in patients with Parkinson disease living in Hong Kong and Taiwan.

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.
150

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females at least 30 years of age with a diagnosis of symptomatic, idiopathic Parkinson disease, stage 1-4 on the Modified Hoehn and Yahr Scale
  • Females either surgically sterile or at least 2 years postmenopausal, or using a reliable method of contraception for at least 2 months prior to study entry
  • Females of childbearing potential with a negative pregnancy test at the screening visit and not nursing
  • Patients with at least 3 of the 4 cardinal signs of Parkinson disease (i.e., rigidity, bradykinesia, resting tremor, postural instability) and without any other known or Suspected cause for their Parkinsonism
  • Patients on levodopa therapy who show a good response to levodopa and be on a stable dosage of levodopa for least 1 month prior to study entry
  • Patients able to take oral medication
  • Patients must give voluntary written consent for study participation and must sign a Patient Informed Consent Form at the screening visit, prior to initiation of any study-related procedures

Exclusion Criteria:

  • Atypical parkinsonian syndromes secondary to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy, multiple-system atrophy)
  • Dementia that could impair compliance with medication and/or preclude giving informed consent (i.e., Mini-Mental Status Examination score ≤22)
  • History of psychosis
  • History of active epilepsy (e.g., occurrence of a seizure) within 1 year prior to screening
  • Second or third degree atrioventricular block or sick sinus syndrome, resting heart rate below 50 beats per minute, congestive heart failure (New York Heart Association functional Class III or IV), myocardial infarction within 6 months of randomization, or other clinically significant heart conditions (e.g., coronary artery disease) that might negatively affect the possibility of the patient completing the study
  • Clinically significant liver disease that may prevent the patient from completing the study and/or elevation in total bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH), serum glutamate pyruvate transaminase (SGPT), or serum glutamate oxaloacetate transaminase (SGOT) of >1.5 times the upper limit of the normal values
  • Clinically significant renal disease that may prevent the patient from completing the study and/or elevation in serum creatinine of >1.5 times the upper limit of the normal values
  • Presence of active neoplastic disease
  • Surgery within 6 months of the baseline/randomization visit which, in the opinion of the investigator, might negatively impact the patient's participation in the study, or any history of stereotaxic brain surgery (e.g., thalamotomy, pallidotomy, or any other deep brain stimulation for reduction of parkinsonian symptoms)
  • Supine systolic blood pressure less than 100 mm Hg or evidence of a ≥20-mm Hg decline in systolic blood pressure at 2 minutes after standing, compared with the previous supine systolic blood pressure obtained after 5 minutes of quiet rest, if the decline in blood pressure upon standing is associated with symptoms (i.e., symptomatic orthostatic hypotension)
  • Use of dopamine agonist medications (e.g., bromocriptine, pergolide) in the 2 months prior to study entry (allowed medications: selegiline, anticholinergics, and amantadine therapy at a stable dosage for 60 days prior to study entry and remaining stable throughout the study)
  • Use of neuroleptics, alpha-methyldopa, or flunarizine within the past 6 months
  • Use of any of the following drugs within 3 months of study entry: methylphenidate, cinnarizine, reserpine, amphetamine, and monoamine oxidase-A inhibitors (e.g., pargyline, phenelzine, or tranylcypromine)
  • Use of pramipexole within the past 3 months or a history of adverse reaction or allergy to pramipexole
  • Unstable dosage of centrally active therapies (e.g., hypnotics, antidepressants, anxiolytics) within the past 60 days
  • Electroconvulsive therapy within 90 days of the baseline/randomization visit
  • Participation in other investigational drug studies or receipt of other investigational drugs within 30 days prior to baseline/randomization. Investigational drugs for Parkinson disease must have been discontinued for 90 days prior to baseline/randomization. Additionally, patients previously randomized into this study and who then discontinued study participation are not to be re-entered into the study
  • Positive hepatitis B screen (assessed at the screening visit)

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
Experimental: Pramipexole - escalation dose
Drug: Pramipexole

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 the sum of the UPDRS (Unified Parkinson Disease Rating Scale) Parts II and III total scores.
Time Frame: up to 15 weeks
up to 15 weeks
Number of patients with clinically significant changes in vital signs
Time Frame: up to 15 weeks
up to 15 weeks
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 15 weeks
up to 15 weeks
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram)
Time Frame: up to 15 weeks
up to 15 weeks
Number of patients with adverse events
Time Frame: up to 15 weeks
up to 15 weeks

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
Change from baseline in the individual UPDRS Part II and Part III total scores
Time Frame: up to 15 weeks
up to 15 weeks
Change from baseline the individual items in the UPDRS Part II and Part III
Time Frame: up to 15 weeks
up to 15 weeks
Change from baseline in the Modified Hoehn and Yahr Scale
Time Frame: up to 15 weeks
up to 15 weeks
Change from baseline in the number of "off" hours in those patients who had been on levodopa therapy
Time Frame: up to 15 weeks
up to 15 weeks
Change from baseline in the Mini-Mental Status Examination
Time Frame: up to 15 weeks
up to 15 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

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.
November 1, 1998

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.
January 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 24, 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 26, 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 27, 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 27, 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 26, 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.
  • 248.362

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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