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

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 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


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

Value
https://center6.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