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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Parkinson Disease

Treatments

Drug: Pramipexole

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02177357

248.362

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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)