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A study of combination therapy with Chlorpromazine and L-DOPA in dystonia

A study of combination therapy with Chlorpromazine and L-DOPA in dystonia - A study of combination therapy with Chlorpromazine and L-DOPA in dystonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057016
Enrollment
60
Registered
2025-03-01
Start date
2025-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia as defined by Fahn in 1988, diagnosed as primary oromandibular, eyelid, cervical, upper limb, unilateral, or generalized dystonia as classified by Bressman et al. in 2006

Interventions

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 a

Sponsors

Kumamoto Neurosurgical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Dystonia as defined by Fahn in 1988, diagnosed as primary oromandibular, eyelid, cervical, upper limb, unilateral, or generalized dystonia as classified by Bressman et al. in 2006 2) Patients who have given written informed consent to participate in the study 3) Individuals who have not received botulinum treatment in the past three months. 4) Individuals who have not altered their oral medication in over three months. 5) Patients aged 50 years or older. For women, this includes postmenopausal patients, defined as those who have not menstruated for at least 12 consecutive months or those who have had both ovaries removed.

Exclusion criteria

Exclusion criteria: 1) Under 15 years of age 2) Those with other diseases 3) Those with serious renal or hepatic impairment 4) Pregnant women and women of childbearing age who have not taken effective measures for contraception 5) Other materials that are judged to be unsuitable for this research

Design outcomes

Primary

MeasureTime frame
Prescribe CPZ 5mg and LDOPA 50mg 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 100mg 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 150mg 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.

Countries

Japan

Contacts

Public ContactNobuhiro Inoue

Kumamoto Neurosurgical Hospital Neurosurgery

ninoue@knh.co.jp0963723911

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026