Parkinson Disease
Conditions
Brief summary
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).
Detailed description
The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper). The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks). Study Hypothesis: Comparison(s):
Interventions
DRUGPramipexole 0.5 mg tablets
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism) (1) Patients meeting all of the following inclusion criteria 1. Patients of at least 20 years of age 2. In- or outpatients of either sex. 3. Patients in any stage on the modified Hoehn and Yahr severity scale
Exclusion criteria
* Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour. * Patients with subjective symptoms derived from orthostatic hypotension. * Patients with hypotension (systolic blood pressure \<100 mmHg) * Patients with concomitant illness such as severe cardiac, renal, and hepatic disease * Patients with a current or past history of epilepsy * Pregnant, possibly pregnant, or lactating women * Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study. * Patients who judged incompetent to give consent * Others judged by the investigator or co-investigator to be ineligible as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy | — |
Outcome results
None listed