臨床研究等提出・公開システム

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 (TIPPS)

Trerief Impact in PD PET Study (TIPPS)

Ouchi Yasuomi

Hamamatsu University School of Medicine

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka

ouchi@hama-med.ac.jp

Ouchi Yasuomi

Hamamatsu University School of Medicine

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka

+81-53-435-2466

ouchi@hama-med.ac.jp

Not Recruiting

Aug. 01, 2015

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

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

Exclusion criteria are following
1) Patients with parkinsonism except Parkinson's disease
2) Patients with epilepsy
3) Patients with a history of surgery for Parkinson's disease 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

Both

Parkinson's disease

[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.
[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.

Parkinson's disease

D010300

Binding potential of the following PET ligands
1) 11C-CFT (binds to dopamine transporter)
2) 11C-DPA713 (binds to translocator protein in activated microglia)

1) Efficacy
Changes in
- scores of modified Hoehn-Yahr severity
- total scores of UPDRS part I, II and III
- subscores of UPDRS
- total and specific scores of PDQ-39
- 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

+81-53-435-2680

Feb. 05, 2019

No

none