臨床研究等提出・公開システム

Date of registration	Aug. 22, 2023
Last modified on	Nov. 07, 2024
Trial ID	jRCT2021230019

Scientific Title	Phase II clinical study of OP-2024 in advanced Parkinson's disease
Public Title	OP-2024-003 study

Contact for Scientific Queries	Name	Taguchi Fumi
	Affiliation	OHARA Pharmaceutical Co.,Ltd.
	Address	36F St.Luke's Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp
Contact for Public Queries	Name	Department of Clinical Development
	Affiliation	OHARA Pharmaceutical Co.,Ltd.
	Address	36F St.Luke's Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 01, 2023
Actual date of first enrollment		Nov. 29, 2023
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)Patients who understand the informed consent form and have provided written consent. 2)Patients diagnosed with "clinically established Parkinson's disease" according to MDS criteria. 3)Patients with modified Hoehn and Yahr stages I-IV in ON state. 4)Patients treated with approval levodopa/carbidopa hydrate tablets at screening (total daily dose of levodopa >=300 mg, four times per day). 5)Patients with an estimated OFF time of >= 2.5 hours per day at screening. 6)Patients with Mini mental state examination (MMSE) score >= 24 at screening.
	Exclusion Criteria	1)Patients diagnosed with nonideopathic Parkinson's disease. 2) Patients who received deep brain stimulation (DBS), Stereotactic surgery, levodopa/carbidopa hydrate enteral combination solution or foslevodopa/foscarbidopa hydrate combination subcutaneous infusion for Parkinson's disease. 3)Patients who received any unapproved drug within 12 weeks or 5 times the half-life, whichever is longer, prior to screening. 4)Patients who received the following drugs 4 weeks prior to screening, or who are expected to receive the following drugs during the study period. levodopa (single agent), COMT inhibitors, benserazide hydrochloride, apomorphine, alpha-methyldopa, reserpine, tetrabenazine, non-selective MAO inhibitors, iron preparations 5) Patients with or at risk of having angle closure glaucoma.
	Age Minimum	30age old over
	Age Maximum	85age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Parkinson's disease
Intervention(s)		Subjects receive OP-2024-C or levodopa/carbidopa hydrate tablets single or multiple oral doses.
Primary Outcome(s)		Safety
Secondary Outcome(s)		Pharmacokinetics, Efficacy

Primary Sponsor	OHARA Pharmaceutical Co., Ltd.

Name of Certified Review Board	National Hospital Organization Sendai Nishitaga Hospital Institutional Review Board
Address	2-11-11 Kagitorihoncho, Taihaku-ku, Sendai, Miyagi, Japan, Miyagi
Approval Status	Approval
Date of approval	July. 14, 2023

Name of Certified Review Board	Juntendo University Hospital Institutional Review Board
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan, Miyagi
Approval Status	Approval
Date of approval	July. 14, 2023

Name of Certified Review Board	Tokyo Metropolitan Neurological Hospital Institutional Review Board
Address	2-6-1 Musashidai, Fuchu, Tokyo, Japan, Miyagi
Approval Status	Approval
Date of approval	July. 14, 2023

Name of Certified Review Board	National Hospital Organaization Utano National Hospital Institutional Review Board
Address	8 Narutaki Ondoyamacho, Ukyo-ku, Kyoto, Kyoto, Japan, Miyagi
Approval Status	Approval
Date of approval	July. 14, 2023

Name of Certified Review Board	National Hospital Organaization Asahikawa Medical Center Institutional Review Board
Address	7-4048 Hanasakicho, Asahikawa, Hokkaido, Japan, Miyagi
Approval Status	Approval
Date of approval	July. 14, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	Nov. 07, 2024	(this page)	Changes
6	July. 17, 2024	Detail	Changes
5	April. 10, 2024	Detail	Changes
4	Feb. 29, 2024	Detail	Changes
3	Dec. 12, 2023	Detail	Changes
2	Sept. 05, 2023	Detail	Changes
1	Aug. 22, 2023	Detail

List of change history