Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274131
First received: January 9, 2006
Last updated: May 18, 2012
Last verified: May 2012

January 9, 2006
May 18, 2012
December 1998
Not Provided
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
- UPDRS Part II (activities of daily living) total score - UPDRS Part III (motor examination) total score
Complete list of historical versions of study NCT00274131 on ClinicalTrials.gov Archive Site
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
- 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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Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).

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):

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Pramipexole 0.125 mg tablets
  • Drug: Pramipexole 0.5 mg tablets
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
February 2004
Not Provided

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00274131
248.506
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd.
Boehringer Ingelheim
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP