ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Survey on Parkinson's Disease (PD) Patients With Depressive Symptoms

This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, July 2008

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00614575
  Purpose

The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.

i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation


Condition Phase
Parkinson Disease
Phase IV

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

MedlinePlus related topics:   Parkinson's Disease   

ChemIDplus related topics:   Pramipexol    Pramipexole dihydrochloride   

U.S. FDA Resources

Study Type:   Observational
Official Title:   BI_Sifrol Tablets Special Drug Use Surveillance (Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Safety i. Incidence & severity of AEs, ii. Drop outs, iii. Days from treatment start to hallucination onset Efficacy i. Changes in UPDRS Part I (Item 3) & III scores, ii. Change in BDI total score at Week 12 [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Efficacy i. Percentage of patients with 50% decrease in the BDI score from baseline [ Time Frame: 12 Weeks ]

Estimated Enrollment:   1000
Estimated Study Completion Date:   March 2009

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • PD patients with depressive symptoms
  • Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.

Exclusion Criteria:

  • PD patients with the past history of suicidal attempt, suicidal ideation or tendency
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614575

Contacts
Contact: Boehringer Ingelheim Study Coordinator     clintriage@rdg.boehringer-ingelheim.com    

Show 245 study locations  Show 245 Study Locations

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim Study Coordinator     Nippon Boehringer Ingelheim Co., Ltd.    
  More Information


Study ID Numbers:   248.635
First Received:   January 31, 2008
Last Updated:   July 25, 2008
ClinicalTrials.gov Identifier:   NCT00614575
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Ganglion Cysts
Depression
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Depressive Disorder
Pramipexol
Behavioral Symptoms

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers