The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs051180098
• Date of registration: 06/03/2019
• Prospective Registration: No
• Primary sponsor: Ito Hidefumi
• Public title: The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease
• Scientific title: A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease
• Date of first enrolment: 09/06/2016
• Target sample size: 120
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs051180098
• Study type: Interventional
• Study design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
• Phase: 2

Contacts

• Name: Jinsoo Koh
• Affiliation: Wakayama Medical University Hospital

• Name: Hidefumi Ito
• Affiliation: Wakayama Medical University Hospital

Key inclusion & exclusion criteria

Inclusion criteria: (1) Those who are at age between 55 and 79 years.
(2) The patients should be within 3 years after the onset of motor symptoms.
(3) The patients should be treated with levodopa/DCI within 3 months and with levodopa/DCI exclusively 28 days right before starting the trial.
(4) The dose of levodopa/DCI should be taken from 150mg/day to 300mg/day.
(5) The participant's score of MMSE should be 25 or higher.
(6) The patient should be judged by attendant doctor to be appropriate for registration.
(7) The agreement with the study should be obtained by the document.
Exclusion criteria: (1) Those who had been treated with the anti-parkinsonian drugs except levodopa/DCI for more than 1month.
(2) Those who are in pregnancy, or possible to be pregnant or those who are in the breast-feeding.
(3) Those who have taken antidepressant and/or anti-psychotic drugs.
(4) Those who have a history of stroke and cerebrovascular disorders.
(5) Those who had a history of epilepsy or those who are in treatment of epilepsy.
(6) Those who have a history of alcohol intoxication, or have the treatment for alcoholic abuse.
(7) Those who have severe comorbidity (liver dysfunction, renal dysfunction and endocrinological disorders).
(8) Those who have a familial history of Parkinson's disease.
(9) Those who have a history of allergic reaction with 123I-ioflupane.

Age minimum: >= 55age old
Age maximum: < 80age old
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's disease

034034

Intervention(s)

L-Dopa/DCI only : The drug is administered per oral at 300 mg/day. The treatment is started within 14 days after registration and continued until day 365.
L-Dopa/DCI + selegiline : L-Dopa/DCI is administered per oral at 300 mg/day and selegiline is administered at 5 mg/day. The treatment is started within 14 days after registration and continued until day 365.
L-Dopa/DCI + zonisamide : L-Dopa/DCI is administered per oral at 300 mg/day and zonisamide is administered at 25 mg/day. The treatment is started within 14 days after registration and continued until day 365.

Primary Outcome(s)

The percent change of SBR of DAT-SPECT from the first evaluation to the final evaluation at 1 year

Secondary Outcome(s)

- Change in UPDRS score (PartII, PartIII)
- Change in PDQ-39 score

Secondary ID(s)

UMIN000022533

Source(s) of Monetary Support

Sumitomo Dainippon Pharma Co., Ltd.

FP Pharmaceutical Corporation

Nihon Medi-Physics Co.,Ltd.

Ethics review

Status: Approval
Approval date: 30/01/2019
Contact:

[e-mail]

Clinical Research Review Committee of Wakayama Medical University

[phone]

[e-mail]