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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019524
Receipt No. 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

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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
Email 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
Email ouchi@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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