UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019524 |
|---|---|
| Receipt number | R000021687 |
| Scientific Title | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2019/03/07 21:02:44 |
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Basic information
Public title
Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images
Acronym
Trerief Impact in PD PET Study (TIPPS)
Scientific Title
Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images
Scientific Title:Acronym
Trerief Impact in PD PET Study (TIPPS)
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine neuroprotective effects of zonisamide (Trerief) on dopaminergic loss and neuroinflammation in the PD brain using PET functional images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Yearly evaluation for the binding potential of the following PET ligands:
1) 11C-CFT (binds to dopamine transporter)
2) 11C-DPA713 (binds to translocator protein in activated microglia)
Key secondary outcomes
Evaluation of the following scores every 6 months;
1) Efficacy
- Changes in
a) scores of modified Hoehn-Yahr severity
b) total scores of UPDRS part I, II and III
c) subscores of UPDRS
d) total and specific scores of PDQ-39
e) total and specific scores of NPI
- Duration from study start until any therapeutic changes (addition, dosage, administration of any anti-parkinsonian drugs)
2) Safety
- Adverse events
- Clinical tests/Vital sign/Body weight
3) Pharmacokinetics
- Plasma zonisamide concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Zonisamide treatment group:
Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
Interventions/Control_2
Zonisamide non-treatment group:
Only Levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are following;
1) Early Parkinson's disease patients medicated once with levodopa/DCI and other anti-parkinsonian drugs excluding zonisamide
2) Patients under 80 years old
3) Patients who have voluntarily provided written informed consent to participate in the study
Key exclusion criteria
Exclusion criteria are following;
1) Patients with parkinsonism except Parkinson's disease
2) Patients with epilepsy
3) Patients with a history of surgery for PD within 6 months before screening
4) Patients treated with zonisamide, selegiline and/or pramipexole within 3 months before screening
5) Patients with any severe psychiatric symptoms, such as confusion, hallucination, delusion and abnormal behaviors
6) Patients with any histories of malignant syndrome
7) Patients with a history of drug allergy for zonisamide
8) Patients participating any other clinical studies (intervention) when screening
9, 10) Patients evaluated as unsuitable for participation in the study by physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuomi OUCHI, MD, PhD. |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofuncional Imaging, Medical Photonics Research Center
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2466
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuomi OUCHI, MD, PhD. |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofuncional Imaging, Medical Photonics Research Center
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2466
Homepage URL
ouchi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
浜松医科大学附属病院（静岡県）、聖隷浜松病院（静岡県）、浜松医療センター（静岡県）、磐田市立総合病院（静岡県）、静岡てんかん・神経医療センター（静岡県）、静岡赤十字病院（静岡県）、浜松労災病院（静岡県）、北斗わかば病院（静岡県）、河野内科神経内科（静岡県）、大阪大谷大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Change over to specified clinical trials.
Management information
Registered date
| 2015 | Year | 10 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021687
