Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation; Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia); Parkinsons disease newly diagnosed within the past 2 years; Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1); Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Previous history of allergic response or complications with pramipexole (PPX) or its excipients; Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy); The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline; The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline; If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline; The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease; The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease; The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery); History of stereotactic brain surgery; Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study; History of active epilepsy (i.e., occurrence of a seizure) within the past year; Symptomatic orthostatic hypotension prior to randomization; Malignant melanoma or history of previously treated malignant melanoma; Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine; Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1); Patients who are currently pregnant or planning pregnancy during the study, or lactating; Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization; History of psychosis; A diagnosis of dementia
Sites / Locations
- 248.595.0122 Boehringer Ingelheim Investigational Site
- 248.595.0104 Boehringer Ingelheim Investigational Site
- 248.595.0133 Boehringer Ingelheim Investigational Site
- 248.595.0140 Boehringer Ingelheim Investigational Site
- 248.595.0112 Boehringer Ingelheim Investigational Site
- 248.595.0113 Boehringer Ingelheim Investigational Site
- 248.595.0105 Boehringer Ingelheim Investigational Site
- 248.595.0119 Boehringer Ingelheim Investigational Site
- 248.595.0124 Boehringer Ingelheim Investigational Site
- 248.595.0123 Boehringer Ingelheim Investigational Site
- 248.595.0109 Boehringer Ingelheim Investigational Site
- 248.595.0115 Boehringer Ingelheim Investigational Site
- 248.595.0106 Boehringer Ingelheim Investigational Site
- 248.595.0103 Boehringer Ingelheim Investigational Site
- 248.595.0127 Boehringer Ingelheim Investigational Site
- 248.595.0137 Boehringer Ingelheim Investigational Site
- 248.595.0101 Boehringer Ingelheim Investigational Site
- 248.595.0111 Boehringer Ingelheim Investigational Site
- 248.595.0131 Boehringer Ingelheim Investigational Site
- 248.595.0134 Boehringer Ingelheim Investigational Site
- 248.595.0141 Boehringer Ingelheim Investigational Site
- 248.595.0102 Boehringer Ingelheim Investigational Site
- 248.595.0129 Boehringer Ingelheim Investigational Site
- 248.595.0139 Boehringer Ingelheim Investigational Site
- 248.595.0136 Boehringer Ingelheim Investigational Site
- 248.595.0120 Boehringer Ingelheim Investigational Site
- 248.595.0107 Boehringer Ingelheim Investigational Site
- 248.595.0118 Boehringer Ingelheim Investigational Site
- 248.595.0114 Boehringer Ingelheim Investigational Site
- 248.595.0116 Boehringer Ingelheim Investigational Site
- 248.595.0108 Boehringer Ingelheim Investigational Site
- 248.595.0121 Boehringer Ingelheim Investigational Site
- 248.595.43005 Boehringer Ingelheim Investigational Site
- 248.595.43003 Boehringer Ingelheim Investigational Site
- 248.595.43001 Boehringer Ingelheim Investigational Site
- 248.595.43002 Boehringer Ingelheim Investigational Site
- 248.595.43004 Boehringer Ingelheim Investigational Site
- 248.595.35803 Boehringer Ingelheim Investigational Site
- 248.595.35804 Boehringer Ingelheim Investigational Site
- 248.595.35801 Boehringer Ingelheim Investigational Site
- 248.595.3306A Centre Hospitalier du Pays d'Aix
- 248.595.3306B Centre Hospitalier du Pays d'Aix
- 248.595.3306C Centre Hospitalier du Pays d'Aix
- 248.595.3301A Hôpital Gabriel Montpied
- 248.595.3301B Hôpital Gabriel Montpied
- 248.595.3303A Cabinet Médical
- 248.595.3307A Hôpital Roger Salengro
- 248.595.3307B Hôpital Roger Salengro
- 248.595.3302A Hôpital La Timone
- 248.595.3302B Hôpital La Timone
- 248.595.3305A Hôpital Purpan
- 248.595.3305C Hôpital Purpan
- 248.595.49006 Boehringer Ingelheim Investigational Site
- 248.595.49008 Boehringer Ingelheim Investigational Site
- 248.595.49007 Boehringer Ingelheim Investigational Site
- 248.595.49011 Boehringer Ingelheim Investigational Site
- 248.595.49016 Boehringer Ingelheim Investigational Site
- 248.595.49009 Boehringer Ingelheim Investigational Site
- 248.595.49004 Boehringer Ingelheim Investigational Site
- 248.595.49010 Boehringer Ingelheim Investigational Site
- 248.595.49005 Boehringer Ingelheim Investigational Site
- 248.595.49012 Boehringer Ingelheim Investigational Site
- 248.595.49001 Boehringer Ingelheim Investigational Site
- 248.595.49015 Boehringer Ingelheim Investigational Site
- 248.595.49014 Boehringer Ingelheim Investigational Site
- 248.595.39004 Università degli Studi di Bari
- 248.595.39009 Ospedale di Bellaria
- 248.595.39005 Ospedale della Misericordia
- 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento
- 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena
- 248.595.39011 Ospedale S. Raffaele - IRCCS
- 248.595.39002 Università Federico II
- 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
- 248.595.39014 Boehringer Ingelheim Investigational Site
- 248.595.39006 Policlinico Universitario Molinette
- 248.595.39007 Ospedale Evangelico Valdese
- 248.595.39013 Ospedale Umberto I
- 248.595.39003 Ospedale di Viareggio
- 248.595.81001 Juntendo University Hospital
- 248.595.81002 Kagawa Prefectural Central Hospital
- 248.595.34003 Hospital de Alcorcon
- 248.595.34001 Hospital Clinic i Provincial of Barcelona
- 248.595.34002 Nuevo Hospital de Sant Pau
- 248.595.34004 Hospital 12 de Octubre
- 248.595.34005 Hospital Mutua de Terrassa
- 248.595.46004 Boehringer Ingelheim Investigational Site
- 248.595.46006 Boehringer Ingelheim Investigational Site
- 248.595.46005 Boehringer Ingelheim Investigational Site
- 248.595.46001 Boehringer Ingelheim Investigational Site
- 248.595.46007 Boehringer Ingelheim Investigational Site
- 248.595.46002 Boehringer Ingelheim Investigational Site
- 248.595.44003 Boehringer Ingelheim Investigational Site
- 248.595.44008 Boehringer Ingelheim Investigational Site
- 248.595.44004 Boehringer Ingelheim Investigational Site
- 248.595.44002 Boehringer Ingelheim Investigational Site
- 248.595.44001 Boehringer Ingelheim Investigational Site
- 248.595.44010 Boehringer Ingelheim Investigational Site
- 248.595.44011 Boehringer Ingelheim Investigational Site
- 248.595.44005 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Early Pramipexole
Delayed Pramipexole
Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).