UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016370 |
|---|---|
| Receipt number | R000019005 |
| Scientific Title | Special Drug Use-results Survey for long-term use of Trelief 50mg/day (TOMORROW-PD) |
| Date of disclosure of the study information | 2015/01/31 |
| Last modified on | 2020/09/11 11:52:36 |
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Basic information
Public title
Special Drug Use-results Survey for long-term use of Trelief 50mg/day (TOMORROW-PD)
Acronym
TOMORROW-PD
Scientific Title
Special Drug Use-results Survey for long-term use of Trelief 50mg/day (TOMORROW-PD)
Scientific Title:Acronym
TOMORROW-PD
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This post-marketing survey is designed to investigate the safety, efficacy and medication adherence of Trelief in patients who receive long-term 50mg/day treatment for Parkinson's disease and "wearing-off" symptoms in regular clinical practice. The effect of the presence of dyskinesia on the safety, efficacy and medication adherence, and QOL are also examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety; Adverse Event
Efficacy; Overall improvement, Clinical symptom score, Wearing-off period, EQ-5D
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following criteria at the start of Trelief 50mg/day treatment are eligible for the survey.
1. Patients with Parkinson's disease and "wearing-off" symptoms.
2. Patients from whom informed consent to publish this survey result are obtained.
3. Patients whose clinical symptom score, wearing-off period, and EQ-5D are all evaluated.
Key exclusion criteria
Patients who had previously received zonisamide, except for cases switching from Trelief 25mg/day treatment to 50mg/day treatment.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Kino |
Organization
Sumitomo Dainippon Pharma Co.,Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0045
Address
6-8, Doshomachi 2-Chome, Chuo-ku, Osaka, Japan
TEL
06-6203-6419
koichi-kino@ds-pharma.co.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Tani |
Organization
Sumitomo Dainippon Pharma Co.,Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0045
Address
6-8, Doshomachi 2-Chome, Chuo-ku, Osaka, Japan
TEL
06-6203-6419
Homepage URL
shunsuke-tani@ds-pharma.co.jp
Sponsor or person
Institute
Sumitomo Dainippon Pharma Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
N/A (https://www.kahyo.com/product/detail/S201909)
Number of participants that the trial has enrolled
566
Results
As evaluation results on the safety and efficacy of zonisamide in this study were similar to those at the time of pre-approval clinical trial (phase III clinical trial), the safety and efficacy under actual clinical conditions could be confirmed.
Results date posted
| 2020 | Year | 09 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age was 72 years old, which was higher than at the time of phase III clinical trial, and was considered to reflect actual clinical conditions. The mean daily dose of L-dopa was 415 mg. For other drugs, dopamine agonists were prescribed in 64.8% of cases and the mean daily doses of pramipexole, ropinirole, and rotigotine used mainly were 2.2 mg, 7.1 mg, and 16.2 mg, respectively.
Participant flow
Patient characteristics, details of anti-Parkinson disease drugs use, and the safety and efficacy of zonisamide was evaluated in 540 cases, 540 cases and 503 cases, respectively.
Adverse events
Overall incidence of adverse drug reactions (ADR) was 8.7% and the most common ADRs were dyskinesia (1.5%) and somnolence (1.3%).
Outcome measures
At the final efficacy assessment, the daily "off" time was shortened by 0.74+-1.64 hours.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Adverse Event
Overall improvement, Clinical symptom score, Wearing-off period, EQ-5D
In the case of a special drug use-results survey, IRB is not required to be held at a medical institution, so there is no IRB approval. Therefore, the same date as the protocol fixation date was entered for the IRB approval date.
Management information
Registered date
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019005
| Research Plan | |
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| Registered date | File name |
| 2020/09/01 | 市販後調査のため該当なし.txt |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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