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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016370
Receipt No. 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

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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
Email 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
Email shunsuke-tani@ds-pharma.co.jp

Sponsor
Institute Sumitomo Dainippon Pharma Co.,Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019005

Research Plan
Registered date File name
2020/09/01 市販後調査のため該当なし.txt

Research case data specifications
Registered date File name

Research case data
Registered date File name


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