Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062079) titled 'Research on the treatment of tic disorders and Tourette's syndrome with
Chlorpromazine and LDOPA' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kumamoto Neurosurgial Hospital
Condition:
Condition - Chronic tic disorder is a condition characterized by involuntary movements that begin in
childhood and may persist into adulthood. Many individuals with this disorder also
experience obsessive-compulsive disorder (OCD).
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We are
planning a new study that will evaluate the treatment of both motor and vocal tics using
Chlorpromazine and L-DOPA.
Purpose:
To investigate the safety and efficacy of the combination therapy using Chlorpromazine and
L-DOPA for treating tic disorders and Tourette's syndrome.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Prescribe CPZ 5mg and LDOPA 50 mg per day and schedule a checkup in two weeks.
Two weeks after the clinical trial begins, we will evaluate the symptoms and side effects.
At that time, 5mg of CPZ and 100 mg of LDOPA will be prescribed. The patient will
then be asked to return for a follow-up visit two weeks later.
Four weeks after the clinical trial begins, we will evaluate the symptoms and side effects.
At that time, 115mg of CPZ and 150 mg of LDOPA will be prescribed. The patient will
then be asked to return for a follow-up visit two weeks later.
After eight weeks from the start of the clinical trial, symptoms and side effects will be
evaluated, and the trial will be terminated. Patients will then transition to standard
treatment. If the patient wishes, we will continue the same treatment.
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male and Female
Key inclusion criteria - Chronic tic disorder is a condition characterized by involuntary movements that begin in
childhood and may persist into adulthood. Many individuals with this disorder also
experience obsessive-compulsive disorder (OCD).
Key exclusion criteria - mental retardation
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 31 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2031 Year 08 Month 14 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071030
Disclaimer: Curated by HT Syndication.