Parkinson Disease Clinical Trial
Official title:
Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction
| NCT number | NCT00613756 |
| Other study ID # | 248.548 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | January 31, 2008 |
| Last updated | November 12, 2013 |
| Start date | February 2004 |
| Verified date | November 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
The survey is conducted to collect safety and effectiveness information targeting patients who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily clinical settings in Japan.
| Status | Completed |
| Enrollment | 107 |
| Est. completion date | |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: Patients with Parkinson's disease who have renal dysfunction with pretreatment creatinine clearance =<70mL/min or whose renal dysfunction was determined by the physician Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Boehringer Ingelheim Investigational Site | Asahikawa | |
| Japan | Boehringer Ingelheim Investigational Site | Azumino | |
| Japan | Boehringer Ingelheim Investigational Site | Chuo | |
| Japan | Boehringer Ingelheim Investigational Site | Eiheiji | |
| Japan | Boehringer Ingelheim Investigational Site | Fuji | |
| Japan | Boehringer Ingelheim Investigational Site | Fujinomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Fujisaki | |
| Japan | Boehringer Ingelheim Investigational Site | Fukaya | |
| Japan | Boehringer Ingelheim Investigational Site | Fukui | |
| Japan | Boehringer Ingelheim Investigational Site | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site | Gifu | |
| Japan | Boehringer Ingelheim Investigational Site | Hachioji | |
| Japan | Boehringer Ingelheim Investigational Site | Hamamatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Himeji | |
| Japan | Boehringer Ingelheim Investigational Site | Hiroshima | |
| Japan | Boehringer Ingelheim Investigational Site | Ichinoseki | |
| Japan | Boehringer Ingelheim Investigational Site | Iga | |
| Japan | Boehringer Ingelheim Investigational Site | Iida | |
| Japan | Boehringer Ingelheim Investigational Site | Ina | |
| Japan | Boehringer Ingelheim Investigational Site | Inazawa | |
| Japan | Boehringer Ingelheim Investigational Site | Isehara | |
| Japan | Boehringer Ingelheim Investigational Site | Isezaki | |
| Japan | Boehringer Ingelheim Investigational Site | Iwamizawa | |
| Japan | Boehringer Ingelheim Investigational Site | Kagoshima | |
| Japan | Boehringer Ingelheim Investigational Site | Kajiki | |
| Japan | Boehringer Ingelheim Investigational Site | Kanoya | |
| Japan | Boehringer Ingelheim Investigational Site | Kashiwazaki | |
| Japan | Boehringer Ingelheim Investigational Site | Kawagoe | |
| Japan | Boehringer Ingelheim Investigational Site | Kawasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Koga | |
| Japan | Boehringer Ingelheim Investigational Site | Komae | |
| Japan | Boehringer Ingelheim Investigational Site | Koriyama | |
| Japan | Boehringer Ingelheim Investigational Site | Koshigaya | |
| Japan | Boehringer Ingelheim Investigational Site | Kurashiki | |
| Japan | Boehringer Ingelheim Investigational Site | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site | Maebashi | |
| Japan | Boehringer Ingelheim Investigational Site | Marugame | |
| Japan | Boehringer Ingelheim Investigational Site | Matsudo | |
| Japan | Boehringer Ingelheim Investigational Site | Matsumoto | |
| Japan | Boehringer Ingelheim Investigational Site | Miki | |
| Japan | Boehringer Ingelheim Investigational Site | Mito | |
| Japan | Boehringer Ingelheim Investigational Site | Miyazaki | |
| Japan | Boehringer Ingelheim Investigational Site | Miyoshi | |
| Japan | Boehringer Ingelheim Investigational Site | Mooka | |
| Japan | Boehringer Ingelheim Investigational Site | Morioka | |
| Japan | Boehringer Ingelheim Investigational Site | Moroyama | |
| Japan | Boehringer Ingelheim Investigational Site | Nagahama | |
| Japan | Boehringer Ingelheim Investigational Site | Nagakute | |
| Japan | Boehringer Ingelheim Investigational Site | Nagasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Nagoya | |
| Japan | Boehringer Ingelheim Investigational Site | Nanao | |
| Japan | Boehringer Ingelheim Investigational Site | Nangoku | |
| Japan | Boehringer Ingelheim Investigational Site | Narita | |
| Japan | Boehringer Ingelheim Investigational Site | Nishinomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Ogaki | |
| Japan | Boehringer Ingelheim Investigational Site | Oita | |
| Japan | Boehringer Ingelheim Investigational Site | Okawa | |
| Japan | Boehringer Ingelheim Investigational Site | Okayama | |
| Japan | Boehringer Ingelheim Investigational Site | Okinawa | |
| Japan | Boehringer Ingelheim Investigational Site | Onga | |
| Japan | Boehringer Ingelheim Investigational Site | Onojo | |
| Japan | Boehringer Ingelheim Investigational Site | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site | Oshu | |
| Japan | Boehringer Ingelheim Investigational Site | Sado | |
| Japan | Boehringer Ingelheim Investigational Site | Sagamihara | |
| Japan | Boehringer Ingelheim Investigational Site | Saitama | |
| Japan | Boehringer Ingelheim Investigational Site | Sanjo | |
| Japan | Boehringer Ingelheim Investigational Site | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site | Sekigahara | |
| Japan | Boehringer Ingelheim Investigational Site | Shimotsuke | |
| Japan | Boehringer Ingelheim Investigational Site | Shingu | |
| Japan | Boehringer Ingelheim Investigational Site | Shunan | |
| Japan | Boehringer Ingelheim Investigational Site | Suita | |
| Japan | Boehringer Ingelheim Investigational Site | Takasago | |
| Japan | Boehringer Ingelheim Investigational Site | Takatsuki | |
| Japan | Boehringer Ingelheim Investigational Site | Togitsu | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Adachi-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Bunkyo-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Chiyoda-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Itabashi-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Meguro-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Ota-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Setagaya-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Shibuya-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Shinjuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Suginami-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Toride | |
| Japan | Boehringer Ingelheim Investigational Site | Toyoake | |
| Japan | Boehringer Ingelheim Investigational Site | Tsukuba | |
| Japan | Boehringer Ingelheim Investigational Site | Uki | |
| Japan | Boehringer Ingelheim Investigational Site | Wakayama | |
| Japan | Boehringer Ingelheim Investigational Site | Yamagata | |
| Japan | Boehringer Ingelheim Investigational Site | Yamaguchi | |
| Japan | Boehringer Ingelheim Investigational Site | Yokohama | |
| Japan | Boehringer Ingelheim Investigational Site | Yokosuka | |
| Japan | Boehringer Ingelheim Investigational Site | Yonago | |
| Japan | Boehringer Ingelheim Investigational Site | Yoshinogawa | |
| Japan | Boehringer Ingelheim Investigational Site | Yufu |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events | up to 12 weeks | No | |
| Primary | Incidence of adverse drug reactions (ADRs | up to 12 weeks | No | |
| Primary | Incidence of serious adverse events (SAEs) | up to 12 weeks | No | |
| Secondary | Modified Hoehn & Yahr rating scale | change from baseline to week 12 | No | |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) part III total score | change from baseline to week 12 | No | |
| Secondary | Physician's overall judgement by medical interview into 4 grades (5 categories) | week 12 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05415774 -
Combined Deep Brain Stimulation in Parkinson's Disease
|
N/A | |
| Recruiting |
NCT04691661 -
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
|
Phase 2 | |
| Active, not recruiting |
NCT05754086 -
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
|
||
| Completed |
NCT04045925 -
Feasibility Study of the Taïso Practice in Parkinson's Disease
|
N/A | |
| Recruiting |
NCT04194762 -
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
|
N/A | |
| Completed |
NCT02705755 -
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
|
Phase 2 | |
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Recruiting |
NCT05830253 -
Free-living Monitoring of Parkinson's Disease Using Smart Objects
|
||
| Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
| Recruiting |
NCT06139965 -
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
|
||
| Completed |
NCT04580849 -
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
|
N/A | |
| Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
| Completed |
NCT03980418 -
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
|
N/A | |
| Completed |
NCT04942392 -
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
|
N/A | |
| Terminated |
NCT03446833 -
LFP Beta aDBS Feasibility Study
|
N/A | |
| Completed |
NCT03497884 -
Individualized Precise Localization of rTMS on Primary Motor Area
|
N/A | |
| Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
| Recruiting |
NCT04997642 -
Parkinson's Disease and Movement Disorders Clinical Database
|
||
| Completed |
NCT04117737 -
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
|
N/A | |
| Recruiting |
NCT03618901 -
Rock Steady Boxing vs. Sensory Attention Focused Exercise
|
N/A |