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Clinical trial of perampanel in the treatment of paroxysmal kinesigenic dyskinesia

Clinical trial of perampanel in the treatment of paroxysmal kinesigenic dyskinesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072371
Enrollment
Unknown
Registered
2023-06-12
Start date
2023-06-20
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

paroxysmal kinesigenic dyskinesia

Interventions

Test:perampanel
Control:oxcarbazepine

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Conforming to PKD clinical diagnostic criteria: All core symptoms must be present: (1) episodes of involuntary movements, including dystonia, chorea, ballism, or a combination of these, which are precipitated by sudden voluntary movements; (2) no loss of consciousness during attacks; Supporting evidence: (1) aura; (2) duration of attacks = 18 years old, male or female. 3. PKD severity score > 1. 4. Volunteer to participate in clinical trials and be able to understand and obey the research procedures. Informed consent was obtained from the subject.

Exclusion criteria

Exclusion criteria: 1. With allergy to both drugs in this test, or with history of severe allergy; 2. Secondary PKD patients; 3. With other nervous system diseases that affect the evaluation; 4. PKD severity score = 0; 5. With clinically unstable disease history (heart disease, tumor, hemopathy, liver disease, kidney disease, etc.) that may be harmful in the past 1 year; 6. With severe anxiety, depression or agitation; 7. Hepatic or renal dysfunction; 8. Pregnant or lactant women, or subjects who cannot use appropriate contraceptives during the trial; 9. Unable to complete the follow-up; 10. Subjects who participated in another drug test and used other test drug in the last 30 days; 11. Only one of the different subjects from the same family and living in the same residence can be included to avoid treatment confusion; 12. The investigators believe that the subject has poor compliance or there are other factors unsuitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
PKD severity score;

Secondary

MeasureTime frame
adverse event incidence rate;

Countries

China

Contacts

Public ContactLi Cao

Shanghai Sixth People's Hospital

caoli@rjlab.cn+86 134 7261 0202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026