Long-Term Administration Study of SND 919 Tablets in Parkinson's Disease - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00274131

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Administration Study of SND 919 Tablets in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274131

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Nippon Boehringer Ingelheim Co., Ltd.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	248.506
Study First Received:	January 9, 2006
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00274131 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Neurotransmitter Agents
Ganglion Cysts
Antioxidants
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Dopamine Agonists
Pramipexol
Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases

Neurodegenerative Diseases
Protective Agents
Pramipexol
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009