Clinical trial NCT00560508 (phase 2/phase 3, status: completed)
Conditions: parkinson disease
ICD codes: G20
Drugs: pramipexole immediate release, pramipexole extended release
SMILES: CCCN[C@H]1CCC2=C(C1)SC(N)=N2, CCCN[C@H]1CCC2=C(C1)SC(N)=N2
Eligibility criteria:

        Inclusion criteria

          1. Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom
             the onset began at the age of forty or younger.

          2. Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.

          3. Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or
             L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before
             the baseline visit (Visit 2).

          4. Patients who exhibit any therapeutically problematic issues or status based on L-DOPA
             therapy:

               -  wearing-off phenomena

               -  no on /delayed on

               -  dystonia at off time

               -  on-off phenomena

               -  freezing phenomena at off time

               -  the sub-optimal dose of L-DOPA had been administered due to side effects (such as
                  dyskinesia), or therapeutical strategy

        Exclusion criteria

          1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or
             degenerative diseases.

          2. Dementia, as defined by a Mini-Mental State Examination (MMSE) score <24 at screening
             visit.

          3. Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or
             completion of the trial and/or put the patient at risk if he/she takes part in the
             trial.

          4. 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).

          5. Clinically significant ECG abnormalities at screening visit, according to
             investigator's judgement.

          6. Clinically significant hypotension or symptomatic orthostatic hypotension (i.e.,
             clinical symptoms of orthostatic hypotension such as dizziness postural etc 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.

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

          8. Pregnancy (to be excluded by serum pregnancy test at screening visit) or
             breast-feeding.

          9. Sexually active female of childbearing potential not using a medically approved method
             of birth control within one month before to the screening visit and throughout the
             trial period.

         10. Serum levels of AST, ALT, alkaline phosphatases or bilirubin >2 upper limits of normal
             .

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

         12. Patients with a complication or signs of malignant tumours or those within 5 years
             after the treatment.