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Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274131
First received: January 9, 2006
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).
| Condition | Intervention | Phase |
|---|---|---|
| Parkinson Disease | Drug: Pramipexole 0.125 mg tablets Drug: Pramipexole 0.5 mg tablets | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 170 |
| Study Start Date: | December 1998 |
| Estimated Study Completion Date: | February 2004 |
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):
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00274131
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274131
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Nippon Boehringer Ingelheim Co., Ltd. |
More Information
| ClinicalTrials.gov Identifier: | NCT00274131 History of Changes |
| Other Study ID Numbers: |
248.506 |
| Study First Received: | January 9, 2006 |
| Last Updated: | May 18, 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 |
ClinicalTrials.gov processed this record on September 19, 2017