臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 05, 2025
Last modified on	Sept. 10, 2025
Trial ID	jRCT2021240047

Scientific Title	Phase III clinical study of OP-2024 in patients with advanced Parkinson's disease
Public Title	OP-2024-004 study

Contact for Scientific Queries	Name	Hashimoto Hideaki
	Affiliation	OHARA Pharmaceuitical Co., Ltd
	Address	36F St. Luke's Tower 8-1, Akachi-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 Pharmaceuitical Co., Ltd
	Address	36F St. Luke's Tower 8-1, Akachi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 31, 2025
Actual date of first enrollment		Mar. 26, 2025
Target sample size		168
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Able to understand and provide written informed consent. 2) Subjects with a "clinically confirmed Parkinson's Disease" on the MDS clinical diagnostic criteria for Parkinson's disease. 3) Subjects with modified Hoehn and Yahr stages I-III in ON state. 4) Subjects treated with approval levodopa/carbidopa hydrate tablets at screening (total daily dose of levodopa >=300 mg, at least four times per day). 5) Subjects with OFF time of >= 2.5 hours per day at screening. 6) Patients with a Mini mental state examination (MMSE) score >= 24 at screening.
	Exclusion Criteria	1) Subjects diagnosed with nonideopathic Parkinson's disease. 2) Subjects who received deep brain stimulation (DBS), Stereotactic surgery, levodopa/carbidopa hydrate enteral combination solution or for Parkinson's disease. 3) Subjects who received any unapproved drug within 12 weeks prior to screening. 4) Subjects 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), foslevodopa/foscarbidopa hydrate combination subcutaneous infusion, benserazide hydrochloride, Levodopa/Carbidopa/Entacapone combination tablet, apomorphine, alpha-methyldopa, reserpine, tetrabenazine, non-selective MAO inhibitors, iron preparations 5) Subjects 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 or levodopa/carbidopa hydrate tablets multiple oral doses.
Health Condition(s) Code		D010300
Intervention(s) Code		D012646
Primary Outcome(s)		Efficacy (OFF time base on patients dairy)
Secondary Outcome(s)		Efficacy, Safety

Primary Sponsor	OHARA Pharmaceuitical Co., Ltd

Name of Certified Review Board	Saiseikai Matsuyama Hospital Institutional Review Board
Address	880-2 Yamanishi-cho, Matsuyama, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	National Hospital Organization Kumamoto Saishun Medical Center Institutional Review Board
Address	2659 Suya, Koshi-shi, Kumamoto, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Southern TOHOKU General Hospital Institutional Review Board
Address	7-115, Yatsuyamada, Koriyama-shi, Fukushima, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Medical Corporation Shintokai Yokohama Minoru Clinic Institutional Review Board
Address	1-13-8, Bessho, Minami-ku, Yokohama-shi, Kanagawa, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Aida Hospital Institutional Review Board
Address	216, Hon-cho, Yabuki-cho, Nishishirakawa-gun, Fukushima, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	General Incorporated Association Nihon Hospital Alliance (NHA) Central Institutional Review Board
Address	5-34-7, Shiba, Minato-ku, Tokyo, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Tatsuoka Neurology Clinic Institutional Review Board
Address	35-3, Chuudojibojo-cho Shimogyo-ku, Kyoto-shi, Kyoto, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	National Hospital Organization Asahikawa Medical Center Institutional Review Board
Address	7-4048, Hanasaki-cho, Asahikawa-shi, Hokkaido, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Medical Corporation Takamatsu Neurology Clinic Institutional Review Board
Address	Kashimakonyamachi Bldg.1F, 4-10, Konya-machi, Takamatsu-shi, Kagawa, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	National Hospital Organization Sagamihara National Hospital Institutional Review Board
Address	18-1, Sakuradai, Minami-ku, Sagamihara-shi, Kanagawa, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Yamauchi Clinic Institutional Review Board
Address	1-15-19, Jiyugaoka, Meguro-ku, Tokyo, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Nagasaki Kita Hospitol Institutional Review Board
Address	800, Motomurago, Togitsu-cho, Nishisonogi-gun, Nagasaki, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Iwamizawa Neurology Clinic Institutional Review Board
Address	7johigashi 6-11-15, Iwamizawa-shi, Hokkaido, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Saiseikai Imabari Hospital Institutional Review Board
Address	7-1-6, Kitamura, Imabari-shi,Ehime, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	National Hospital Organization Sendai-Nishitaga Hospital Institution Review Board
Address	2-11-11, Kagitorihon-cho, Taihaku-ku, Sendaihi-shi, Miyagi, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	National Hospital Organization Utano National Hospital Institutional Review Board
Address	8, Narutakiondoyama-cho, Ukyo-ku, Kyoto-shi, Kyoto, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Saitama Medical University Hospital Institutional Review Board
Address	38, Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Juntendo University Hospital Institutional Review Board
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Keio University Hospital Institutional Review Board
Address	35, Shinano-machi, Shinjuku-Ku, Tokyo, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	St. Marianna University Group Institutional Review Board
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-Shi, Kanagawa, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Name of Certified Review Board	Aichi Medical University Hospital Institutional Review Board
Address	1-1, Yazakokarimata, Nagakute-shi, Aichi, Japan, Ehime
Approval Status	Approval
Date of approval	Feb. 04, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	Sept. 10, 2025	(this page)	Changes
6	May. 26, 2025	Detail	Changes
5	April. 30, 2025	Detail	Changes
4	Mar. 31, 2025	Detail	Changes
3	Mar. 03, 2025	Detail	Changes
2	Feb. 06, 2025	Detail	Changes
1	Feb. 05, 2025	Detail

List of change history