Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
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|ClinicalTrials.gov Identifier: NCT03727139|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment|
|Parkinson's Disease||Drug: Rasagiline|
The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease.
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000.
This multi-center observational trial will be conducted in Japan.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||AZILECT Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Rasagiline 1 mg
Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Other Name: AZILECT Tablets ("AZILECT" is a registered trademark of Teva Pharmaceutical Industries Ltd.)
- Percentage of Participants who Had One or More Adverse Events [ Time Frame: Month 24 ]
- Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score [ Time Frame: Baseline, Up to Month 24 ]UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III have 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome).
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 ClinicalTrials.gov identifier (NCT number): NCT03727139
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Takeda Selected Site||Recruiting|