A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.
- Conditions
- Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3.MedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease
- Registration Number
- EUCTR2007-003353-90-NL
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 145
1.Male or female patient with idiopathic Parkinson’s disease (PD) confirmed
by at least two of the following signs: resting tremor, bradykinesia, rigidity.
2.Parkinson’s 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 receiving pramipexole IR at least three months prior to baseline
visit (randomization visit, V2)
6. Pramipexole dose should optimized according to the investigator’s
judgement, greater or equal to 1.5 per day, stable and equally divided
times a day, for at least 4 weeks prior to baseline visit (V2)
7.Patients willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other study procedures.
8.Signed informed consent obtained before any study procedures are
carried out (in accordance with ICH-GCP guidelines and local legislation).
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
Medical exclusions:
1.Motor complications under levodopa therapy (e.g. on-off phenomena,
dyskinesia) at screening visit
2.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).
3.Dementia, as defined by a Mini-Mental State Exam score < 24 at screening
visit
4.Any psychiatric disorder according to DSM-IV (Diagnostic and Statistical
Manual of Mental Disorders, 4th edition) 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.
5.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).
6.Clinically significant electrocardiogram (ECG) abnormalities at screening
visit, according to investigator’s judgement.
7.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.
8.Malignant melanoma or history of previously treated malignant melanoma.
9.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.
10.Pregnancy (to be excluded by urinary pregnancy test at screening visit) or
breast-feeding.
11.Sexually active female of childbearing potential (less than 24 months post-menopausal and not surgically sterilised, hysterectomised or bilaterally ovariectomised, or their partner not vasectomised) not using a highly effective method of birth control, i. e. hormonal forms of contraception (such as combined oral contraceptives, hormonal intrauterine devices, implants, injectables) for at least one month prior to the screening visit and throughout the study period (up to the follow-up visit).
12.Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin
> 2 ULN (on screening lab test).
13.Patients with a creatinine clearance < 50 mL/min (estimated by the
Cockcroft and Gault formula and calculated by the local lab or by the
investigator on screening lab test)
Pharmacological exclusions:
14.Any dopamine agonist (except pramipexole IR) within three months prior
to baseline visit.
The following concomitant PD treatments are allowed, provided they are at a stable dose for at least 4 weeks prior to baseline and the investigator does not intend to change this treatment during the treatment phase: L-Dopa+, and/or anti-Parkinsonian anticholinergics, and/or selegiline, rasagiline, or other MAO-B Inhibitors, and/or amantadine, and/or entacapone (or other COMT-Inhibitors), and/or beta-blocke
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole Immediate Release formulation (IR) to Pramipexole Extended Release formulation (ER), and to establish if this successful switch can be obtained with or without dose adaptation.;Secondary Objective: Secondary objectives of the trial are to provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER, to assess safety and tolerability of switching patients with early Parkinson's disease from Pramipexole IR to Pramipexole ER.;Primary end point(s): The primary efficacy endpoint is the proportion of patients successfully switched from pramipexole IR to pramipexole ER or IR at the end of the double-blind treatment phase or maintenance N° 2 (visit 5).
- Secondary Outcome Measures
Name Time Method