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Levodopa and chlorpromazine combination therapy for treatment of primary dystonia

Levodopa and chlorpromazine combination therapy for treatment of primary dystonia - Levodopa and chlorpromazine combination therapy for treatment of primary dystonia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027430
Enrollment
110
Registered
2017-06-01
Start date
2017-06-01
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

primary dystonia

Interventions

chlorpromazine (CP) group On the first day, we prescribe after breakfast, and order to continue for 2 weeks. After 2 weeks continuous treatment, CP 5mg after breakfast, CP 5mg after lunch, a total of

Sponsors

Department of Neurology, Osaka Neurological Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cervical dystonia and blepharospasm was clinically diagnosed according to the definition by Fahn. (Fahn S. Concept and classification of dystonia. Adv Neurol 1988; 50: 1-8.) Written informed consent was obtained

Exclusion criteria

Exclusion criteria: All participants were examined by a single movement disorder specialist who performed general physical and neurological examinations, laboratory tests, and brain magnetic resonance imaging to exclude other causes of dystonia, including birth injury and head trauma.

Design outcomes

Primary

MeasureTime frame
First day of examination, a single movement disorder specialist recorded the participants clinical symptoms with a video camera to assess the objective signs. After that, participants evaluated their subjective clinical signs using a visual analog scale (VAS). We explained to the participants that the left end of the scale indicated the worst possible state, whereas the right end of the scale indicated a healthy state without cervical dystonia or blepharospasm. Participants were directed to self-evaluate their clinical signs separately from any side effects. Second, we recorded the participants clinical symptoms with a video camera again. The second video recording was taken by another doctor who was blinded to the patient back ground and the treatment. Eight weeks after the therapy, patients evaluated subjective score by VAS. Eight weeks after the therapy, video camera was recorded by the doctor who were blinded to the patients background and the treatment, to assess the objective signs. We also evaluate the symptoms after one year. Three movement disorder specialists who were blinded to the treatment and purpose of the examination independently evaluated the objective symptoms from the videos before treatment and after treatment which were randomly presented. We took two videos before treatment (reference video, pre-treatment video), and one video after treatment (post-treatment video). We made one slide with reference video and pre-treatment video, and named A. We also made one slide with reference video and post-treatment video, and named B. A and B presented randomly, and we also randomly presented these sets of videos LDOPA group, CP group, and LDOPA in combination with CP group to the specialists.

Countries

Japan

Contacts

Public ContactSyouhei Kiyota

Osaka Neurological Institute Department of Neurology

dyt3mc@yahoo.co.jp0663330080

Outcome results

None listed

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