臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 30, 2026
Last modified on	Jan. 30, 2026
Trial ID	jRCT1031250693

Scientific Title	Efficacy of Levocarnitine Supplementation for the Maintenance of Motor Function in Patients with Parkinson's Disease and Carnitine Deficiency
Public Title	Effects of Levocarnitine in Patients with Parkinson's Disease and Carnitine Deficiency

Contact for Scientific Queries	Name	Nakajima Asuka
	Affiliation	Juntendo University Nerima Hospital
	Address	3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
	Telephone	+81-3--5923-3111
	E-mail	asnakaji@juntendo.ac.jp
Contact for Public Queries	Name	Nakajima Asuka
	Affiliation	Juntendo University Nerima Hospital
	Address	3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
	Telephone	+81-3-5923-3111
	E-mail	asnakaji@juntendo.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 26, 2022
Target sample size		50
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. Male or female patients aged >50 years and <90 years at the time of obtaining informed consent. 2. Gait speed <1.0 m/s at the time of informed consent, or handgrip strength <28 kg for men and <18 kg for women. 3. Abnormal carnitine fractions on blood testing during the screening period, defined as an acylcarnitine/free carnitine (AC/FC) ratio >0.25. 4. Mini-Mental State Examination (MMSE) score >24. 5. Written informed consent for participation in this study has been obtained. 6. In cases where the patient has difficulty providing a written signature due to their medical condition, written consent may be provided by a proxy after obtaining oral consent from the patient. The proxy shall be limited to a family member or equivalent representative.
	Exclusion Criteria	1. Patients aged <50 years at the time of obtaining informed consent. 2. Patients who initiate treatment with cholinesterase inhibitors during the study period. 3. Patients undergoing dialysis. 4. Patients receiving sodium valproate.
	Age Minimum	50age old over
	Age Maximum	90age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Motor function decline and sarcopenia associated with carnitine deficiency in patients with Parkinso
Intervention(s)		Patients with Parkinson's disease and carnitine deficiency will receive oral levocarnitine at a dose of 1.5 g per day for 16 weeks
Health Condition(s) Keyword		Parkinson's Disease
Intervention(s) Keyword		Carnitine supplementation
Health Condition(s) Code		ICD10: G20
Intervention(s) Code		MeSH Descriptor ID: D002265
Primary Outcome(s)		1. Number of falls within the preceding one-month period at the screening phase, at the end of treatment (16 weeks), and during the follow-up period (32 weeks). 2. Change from baseline to week 16 in the skeletal muscle index at the third lumbar vertebral level (L3 SMI;cm2/m2), calculated from muscle mass at the L3 level. 3. Changes in laboratory parameters, including creatine kinase, albumin, aldolase, and carnitine fractions.
Secondary Outcome(s)		Change from baseline to weeks 24 and 32 in the Parkinson's Disease Questionnaire 39 (PDQ 39) score.

Primary Sponsor	Juntendo University Nerima Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	CRB3180012
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Tokyo
Telephone	+81-3-5802-1584
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	July. 26, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none