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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	13 March 2017
Main ID:	EUCTR2007-004234-16-SK
Date of registration:	18/04/2008
Prospective Registration:	No
Primary sponsor:	Boehringer Ingelheim RCV GmbH & Co KG
Public title:	Long-term safety study of open-label pramipexole extended release (ER) in patients with early Parkinson’s disease (PD).
Scientific title:	Long-term safety study of open-label pramipexole extended release (ER) in patients with early Parkinson’s disease (PD).
Date of first enrolment:	14/01/2008
Target sample size:	520
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004234-16
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Completers of 248.524 will have up to 6 weeks DB-transfer phase in the beginning If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Austria	Czech Republic	Finland	France	Hungary	Netherlands	Slovakia

Contacts

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Address:
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Email:
Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
Completion of trial 248.524 or 248.636.
Male or female with early idiopathic Parkinson´s disease and with Modified Hoehn and Yahr stage I-III.
Patients willing and able to comply with the study procedures.
Signed informed consent.
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:
Premature withdrawal from study 248.524 or 248.636.
Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the study and/or put patient at risk if he/she takes part in the study.
History of psychosis, except history of drug induced hallucinations.
Clinically significant ECG abnormalities.
Clinically significant hypotension (i.e. supine 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) at baseline.
Malignant melanoma or history of previously treated malignant melanoma.
Any other clinically significant disease that could put the patient at risk or could prevent compliance or completion of the study.
Pregnancy and breast-feeding.
Sexually active female of childbearing potential not using medically approved method of birth control.
Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatase or bilirubin > 2 ULN at baseline.
Patients with creatinine clearance < 50 mL/min.
Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.
Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit.
Methylphenidate, cinnarizine, amphetamines within 4 weeks prior to baseline.
Flunarizine within 3 months prior to baseline.
Known hypersensitivity to pramipexole or its excipients.
Drug abuse (including alcohol) according to investigator´s judgement, within 2 years prior to baseline.
Participation in investigational drug studies, other than 248.524 and 248.636, 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.

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

Health Condition(s) or Problem(s) studied

Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.375-
Pharmaceutical form of the placebo: Prolonged-release 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.75-
Pharmaceutical form of the placebo: Prolonged-release 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceutical form of the placebo: Prolonged-release 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.0-
Pharmaceutical form of the placebo: Prolonged-release 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.5-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To assess if patients treated with pramipexole for 12 months (6 months in the previous DB trial 248.524 and then 6 months in the 248.633 trial) demonstrate less functional decline than patients whose treatment was delayed for 6 months (i.e. patients treated with placebo in the previous DB-trial 248.524).
To assess dose adjustments and effects on other efficacy criteria during long-term treatment with pramipexole ER.

Main Objective: To obtain long term safety and tolerability data on pramipexole ER in patients who have previously completed a pramipexole double-blind study in early PD (248.524 or 248.636 trial)

Primary end point(s): No primary efficacy endpoint is set up, because the primary objective of this trial is to obtain long-term safety and tolerability data.

Secondary Outcome(s)

Secondary ID(s)

248.633

2007-004234-16-NL

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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