臨床研究等提出・公開システム

Date of registration	Jan. 31, 2025
Last modified on	Sept. 04, 2025
Trial ID	jRCT2051240254

Scientific Title	An open-label, uncontrolled, single-arm study of NT 201 in patients with spasticity in children.
Public Title	An open-label, uncontrolled, single-arm study of NT 201 in patients with spasticity in children.

Contact for Scientific Queries	Name	Tsushima Shohei
	Affiliation	Teijin Pharma Limited
	Address	2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo 100-8585, Japan
	Telephone	+81-80-8929-6267
	E-mail	nt201p-ct@teijin.co.jp
Contact for Public Queries	Name	Tsushima Shohei
	Affiliation	Teijin Pharma Limited
	Address	2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo 100-8585, Japan
	Telephone	+81-80-8929-6267
	E-mail	nt201p-ct@teijin.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Feb. 01, 2025
Actual date of first enrollment		Feb. 28, 2025
Target sample size		44
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Patients aged 2 or more and less than 15 years at the time of obtaining informed consent (2)Patients who have been diagnosed with upper limb spasticity, lower limb spasticity, or upper and lower limb spasticity and who meet either or both of the following criteria: - Patients who require administration of NT 201 to one or both upper limbs - Patients who require administration of NT 201 to one or both lower limbs (3)Patients who meet the criteria for severity of spasticity at the time of pre-registration examination (4)If patients have previously undergone botulinum toxin treatment, 14 weeks or more have passed since their last botulinum toxin treatment before the pre-registration examination
	Exclusion Criteria	(1)Patients with fixed contractures in the joints (wrists, elbows, knees, ankles, etc.) where NT 201 will be injected (2)Patients who have not seen any therapeutic effect from previous botulinum toxin treatments (3)Patients with an unhealed fracture at the injection site
	Age Minimum	2age old over
	Age Maximum	15age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Upper limb spasticity or Lower limb Spasticity
Intervention(s)		The investigator injects NT 201 into the patient's tonic muscles. The treatment period will be up to 36 weeks after the first dose, and the NT 201 will be administered 2 to 4 times.
Primary Outcome(s)		-Change from baseline in the Modified Ashworth Scale(MAS) score in wrist flexors at 4 weeks after the first injection. -Change from baseline in the Modified Ashworth Scale(MAS) score in planter flexors at 4 weeks after the first injection.

Primary Sponsor	Teijin Pharma Limited

Secondary Sponsor

Name of Certified Review Board	Nara Prefecture General Medical Center IRB
Address	2-897-5, Shichijonishimachi, Nara-shi, Nara
Telephone	+81-742-46-6001
E-Mail	chiken@nara-hp.jp
Approval Status	Approval
Date of approval	Jan. 20, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Sept. 04, 2025	(this page)	Changes
2	April. 15, 2025	Detail	Changes
1	Jan. 31, 2025	Detail

List of change history