Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT00274131 |
Recruitment Status
:
Completed
First Posted
: January 10, 2006
Last Update Posted
: May 21, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: Pramipexole 0.125 mg tablets Drug: Pramipexole 0.5 mg tablets | Phase 3 |
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):
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 170 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long-term Administration Study of SND 919 Tablets in Parkinson's Disease |
Study Start Date : | December 1998 |
Study Completion Date : | February 2004 |

- UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
- 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

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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
- Patients of at least 20 years of age
- In- or outpatients of either sex.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274131
Study Chair: | Boehringer Ingelheim Study Coordinator | Nippon Boehringer Ingelheim Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00274131 History of Changes |
Other Study ID Numbers: |
248.506 |
First Posted: | January 10, 2006 Key Record Dates |
Last Update Posted: | May 21, 2012 |
Last Verified: | May 2012 |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pramipexole |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents |