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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

Resource links provided by NLM:


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
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):

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274131     History of Changes
Other Study ID Numbers: 248.506
Study First Received: January 9, 2006
Last Updated: May 18, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Pramipexole
Anti-Dyskinesia Agents
Antioxidants
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014