Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.
In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity
Drug: Pramipexol Extended Release
Drug: Pramipexol Immediate Release
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).|
- Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score [ Time Frame: baseline and after 33 weeks treatment ]Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.
- Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale [ Time Frame: after 18 weeks of treatment compared to baseline ]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
- Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale [ Time Frame: after 18 weeks of treatment compared to baseline ]Patient rated evaluation of the PD sympoms 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.
- UPDRS II+III Responder Rate (at Least 20% Improvement) [ Time Frame: after 33 weeks treatment ]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.
- UPDRS Part I Change From Baseline [ Time Frame: baseline and after 33 weeks treatment ]UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement
- UPDRS Part II Total Score [ Time Frame: after 33 weeks treatment ]UPDRS II evaluates activities of dailiy living in a score 0-52. Decrease of the score means improvement
- UPDRS Part III Total Score [ Time Frame: after 33 weeks treatment ]UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement
- Beck's Depression Inventory Version I A [ Time Frame: after 33 weeks treatment ]21 item self-rating scale to assess depressive symptoms. Each item is scored from absent (0) to severe (3.) A decrease in the score means improvement
- Likert Scale for Pain Related to PD [ Time Frame: after 33 weeks treatment ]Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement
- Parkinson's Disease Sleep Scale [ Time Frame: after 33 weeks treatment ]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)
- Parkinson's Disease Quality of Life Questionnaire [ Time Frame: after 33 weeks treatment ]Self administered questionnaire addressing 8 domains of health affected by PD. Lower scores relate to better preserved health status
- European Quality of Life Scale [ Time Frame: after 33 weeks treatment ]Standardized health-related quality of life questionnaire. An increase of the score means improvement
- Patients Who Started to Use L-Dopa Rescue Medication [ Time Frame: from trial start on to any time before final assessment of the patient ]L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the FAS population
- Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire) [ Time Frame: any time during the study ]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).
|Study Start Date:||May 2007|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
|Experimental: Pramipexole Extended Release (PPX ER)||Drug: Pramipexol Extended Release|
|Experimental: Pramipexole Immediate Release (PPX IR)||Drug: Pramipexol Immediate Release|
|Placebo Comparator: Placebo||Drug: Placebo|
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim Pharmaceuticals|