Back to resultsLong-term Administration Study of SND 919 Tablets in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pramipexole 0.125 mg tablets
Pramipexole 0.5 mg tablets
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00274131
Brief Title
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
Official Title
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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):
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pramipexole 0.125 mg tablets
Intervention Type
Drug
Intervention Name(s)
Pramipexole 0.5 mg tablets
Primary Outcome Measure Information:
Title
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Nippon Boehringer Ingelheim Co., Ltd.
Official's Role
Study Chair
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.506_U03-3003.pdf
Description
Related Info
Learn more about this trial
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
We'll reach out to this number within 24 hrs