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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00479401
• Date of registration: 25/05/2007
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
• Scientific 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).
• Date of first enrolment: May 2007
• Target sample size: 539
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00479401
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Brazil, Czech Republic, Finland, Germany, Hungary, India, Japan, Malaysia, Russian Federation, Slovakia, Taiwan, Ukraine, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least
two of the following signs: resting tremor, bradykinesia, rigidity.

2. Parkinsons disease diagnosed within 5 years.

3. Patients 30 years of age or older at the time of diagnosis.

4. Modified Hoehn and Yahr stage of 1 to 3.

5. Patients requiring additional therapy/ introduction of therapy (for de novo patients)
to treat their parkinsonian symptoms at the time of enrollment (screening visit, V1)
according to the investigators judgement.

Exclusion Criteria:

1. Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine),
metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases
(e.g., progressive supranuclear palsy).

2. Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit

3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental
Disorders 4th (DSM-IV)

4. History of psychosis

5. Clinically significant electrocardiogram (ECG) abnormalities at screening visit

6. Clinically significant hypotension

7. Malignant melanoma or history of previously treated malignant melanoma

8. Any other clinically significant disease, whether treated or not, that could put the
patient at risk or could prevent compliance or completion of the study

9. Pregnancy

10. Sexually active female of childbearing potential not using a medically approved method
of birth control

11. Serum levels of Aspartate Aminotransferase (AST) , Alanine Aminotransferase (ALT),
alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (ULN)

12. Patients with a creatinine clearance < 50 mL/min

13. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit,
or L-Dopa within 8 weeks prior to baseline visit.

14. Total cumulative duration of prior exposure to Levodopa of more than 3 months.

15. Any medication (including intra-muscular formulations) with central dopaminergic
antagonist activity within 4 weeks prior to the baseline visit

16. Any of the following drugs within 4 weeks prior to the baseline visit:
methylphenidate, cinnarizine, amphetamines.

17. Flunarizine within 3 months prior to baseline visit

18. Known hypersensitivity to Pramipexole or its excipients

19. Drug abuse (including alcohol), according to Investigators judgement, within 2 years
prior to screening.

20. Participation in other investigational drug studies or use of other investigational
drugs within one month or five times the half-life of the investigational drug



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Early Parkinson Disease (Early PD)

Intervention(s)

Drug: Pramipexol Immediate Release

Drug: Placebo

Drug: Pramipexol Extended Release

Primary Outcome(s)

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score [Time Frame: baseline and after 33 weeks treatment]

Secondary Outcome(s)

Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score [Time Frame: after 33 weeks treatment]

Possible Clinically Significant Abnormal Laboratory Parameters [Time Frame: baseline and after 33 weeks of treatment]

UPDRS Part I Change From Baseline [Time Frame: baseline and after 33 weeks 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]

Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire) [Time Frame: from trial start on to any time before final assessment of the patient, up to 33 weeks]

Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale [Time Frame: after 18 weeks of treatment compared to baseline]

Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale [Time Frame: after 18 weeks of treatment compared to baseline]

Change From Baseline in European Quality of Life Visual Analog Scale [Time Frame: after 33 weeks treatment]

Likert Scale for Pain Related to PD [Time Frame: after 33 weeks treatment]

Parkinson's Disease Sleep Scale (PDSS) [Time Frame: after 33 weeks treatment]

Patients Who Started to Use L-Dopa Rescue Medication [Time Frame: from trial start on to any time before final assessment of the patient, up to 33 weeks]

Beck's Depression Inventory Version I A [Time Frame: after 33 weeks treatment]

UPDRS Part II Total Score [Time Frame: after 33 weeks treatment]

UPDRS Part III Total Score [Time Frame: after 33 weeks treatment]

UPDRS II+III Responder Rate (at Least 20% Improvement) [Time Frame: after 33 weeks treatment]

Secondary ID(s)

Eudract No 2007-000073-39

248.524

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/04/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00479401