A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 6.1 Level: pref Classification code 10061536

• Registration Number: EUCTR2005-004949-34-GB
• Lead Sponsor: Boehringer Ingelheim Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-24
• Study Completion: 2009-04-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

1.)Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
2.)Male or female patient with idiopathic PD confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
3.)Parkinson’s disease newly diagnosed within the past 2 years;
4.)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;
5.)Age 30 to 79 years at screening (Visit 1);
6.)Women of childbearing potential must have a negative serum 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 (spermacide + diaphragm); and
7.)Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.)Previous history of allergic response or complications with PPX or its excipients;
2.)Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilson's Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
3.)The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
4.)The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 28 consecutive days prior to baseline;
5.)If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
6.)The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinson’s disease;
7.)The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinson’s disease;
8.)The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
9.)History of stereotactic brain surgery;
10.)Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patient’s participation in the study;
11.)History of active epilepsy (i.e., occurrence of a seizure) within the past year;
12.)Symptomatic orthostatic hypotension prior to randomization;
13.)Malignant melanoma or history of previously treated malignant melanoma;
14.)Patients who have received any of the following drugs (all time periods are calculated from randomization):
•Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within the past 6 months
•Monoamine oxidase (MAO) inhibitors in the past 3 months
•Beta-blockers (e.g., propranolol) to treat PD in the past 30 days. (Beta blockers for other conditions are permitted)
15.)Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);
16.)Patients who are currently pregnant or planning pregnancy during the study, or lactating;
17.)Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
18.)History of psychosis;
19.)A diagnosis of dementia;
20.)Mini-Mental State Exam (MMSE) total score < 24 at Screening (Visit 1);
21.)History of major depression and/or seasonal depression;
22.)History of drug or alcohol dependency within 6 months prior to signing the informed consent form;
23.)Inability to comply with the protocol
24.)Any other clinically significant medical or psychiatric condition or laboratory assay abnormality, which would interfere with the patient’s ability to participate in the study, increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified