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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274131
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : May 21, 2012
Information provided by:
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Pramipexole 0.125 mg tablets Drug: Pramipexole 0.5 mg tablets Phase 3

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:


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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score

Secondary Outcome Measures :
  1. 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

  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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00274131

Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd. 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
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents