Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale

Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale

Time frame: after 18 weeks of treatment compared to baseline

Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale

Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. Responders are the patients with 'much better' and 'very much better' on the score.

Time frame: after 18 weeks of treatment compared to baseline

UPDRS II+III Responder Rate (at Least 20% Improvement)

Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.

Time frame: after 33 weeks treatment

UPDRS Part I Change From Baseline

UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement

Time frame: baseline and after 33 weeks treatment

UPDRS Part II Total Score

UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement

Time frame: after 33 weeks treatment

UPDRS Part III Total Score

UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement

Time frame: after 33 weeks treatment

Beck's Depression Inventory Version I A

The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).

Time frame: after 33 weeks treatment

Likert Scale for Pain Related to PD

Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement

Time frame: after 33 weeks treatment

Parkinson's Disease Sleep Scale (PDSS)

PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)

Time frame: after 33 weeks treatment

Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include: * mobility (e.g. fear of falling when walking): 10 items * activities of daily living (e.g. difficulty cutting food): 6 items * emotional well-being (e.g. feelings of isolation): 6 items * stigma (e.g. social embarrassment): 4 items * social support: 3 items * cognition: 4 items * communication: 3 items * bodily discomfort: 3 items. A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement.

Time frame: after 33 weeks treatment

Change From Baseline in European Quality of Life Visual Analog Scale

European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.

Time frame: after 33 weeks treatment

Patients Who Started to Use L-Dopa Rescue Medication

L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population

Time frame: from trial start on to any time before final assessment of the patient, up to 33 weeks

Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)

mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).

Time frame: from trial start on to any time before final assessment of the patient, up to 33 weeks

Possible Clinically Significant Abnormal Laboratory Parameters

The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.

Time frame: baseline and after 33 weeks of treatment

Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events

Time frame: baseline and after 33 weeks of treatment