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
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
Kumamoto Neurosurgical Hospital Neurosurgery