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 Parkinson's disease (PD)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000073-39-CZ
• Date of registration: 18/04/2007
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim RCV GmbH & Co KG
• Public 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 Parkinson's disease (PD)
• 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 Parkinson's disease (PD)
• Date of first enrolment: 18/06/2007
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000073-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Double-Dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: yes Other specify the comparator: Pramipexol Immediate Release

Countries of recruitment

Austria, Czech Republic, Finland, Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
Male or female patient with idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinson’s disease diagnosed within 5 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 1 to 3.
Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrolment according to the investigator’s judgement.
Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Signed informed consent obtained before any study procedures are carried out
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:
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).
Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit ?
Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.
History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).
Clinically significant electrocardiogram abnormalities at screening visit, according to investigator’s judgement.
Clinically significant hypotension (i.e. supine systolic blood pressure < 90 mmHg) and/or symptomatic orthostatic hypotension (i.e. clinical symptoms of orthostatic hypotension associated with a decline = 20 mmHg in systolic blood pressure and a decline = 10 mmHg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) either at screening visit or at baseline visit.
Malignant melanoma or history of previously treated malignant melanoma.
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.
Pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.
Sexually active female of childbearing potential (less than 6 months post-menopausal and not surgically sterilized) not using a medically approved method of birth control (i.e. oral contraceptives, intrauterine device, or double-barrier) for at least one month prior to the screening visit and throughout the study period (up to the follow-up visit).
Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin > 2 ULN (on screening lab test).
Patients with a creatinine clearance < 50 mL/min (estimated by the Modification of Diet in Renal Disease - MDRD - formula and calculated by the central lab on screening lab test)

Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
Total cumulative duration of prior exposure to Levodopa of more than 3 months.
Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc).
Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
Flunarizine within 3 months prior to baseline visit.
Known hypersensitivity to Pramipexole or its excipients.
Drug abuse (including alcohol), according to Investigator’s judgement, within 2 years prior to screening.
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 (whichever is longer) prior to baseline visit.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Intervention(s)

Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Other descriptive name: Prolonged release tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.375-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Other descriptive name: Prolonged release tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.75-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Other descriptive name: Prolonged release tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Other descriptive name: Prolonged release tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Other descriptive name: Prolonged release tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of

Primary Outcome(s)

Main Objective: To determine the efficacy (as measured by the change from baseline to the end of the maintenance period in the total score for UPDRS parts II and III combined), safety and tolerability of Pramipexole ER compared with placebo and Pramipexole IR in patients with early Parkinson's disease. Superiority of pramipexole ER to placebo and non-inferiority of pramipexole ER to IR will be evaluated in a hierarchical system of hypotheses.

Primary end point(s): The primary efficacy endpoint of the trial is the change from baseline to end of the maintenance period in UPDRS parts II+III score.

Secondary Objective: Cost-effectiveness analysis
Pramipexole plasma concentrations (exposure) will be assessed

Secondary ID(s)

248.524

2007-000073-39-FI