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A randomized, controlled, multicenter clinical study evaluating the efficacy and safety of perampanel versus levetiracetam monotherapy in newly diagnosed focal epilepsy greater than or equal to 12 years of age

A randomized, controlled, multicenter clinical study evaluating the efficacy and safety of perampanel versus levetiracetam monotherapy in newly diagnosed focal epilepsy greater than or equal to 12 years of age

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059080
Enrollment
Unknown
Registered
2022-04-24
Start date
2022-04-15
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

Epilepsy

Interventions

Group perampanel:Oral perampanel
Group Levetiracetam:Oral Levetiracetam

Sponsors

The Seventh Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >= 12 years old, male or female; 2. Interval>24h, >=2 times, unprovoked focal seizures (with or without generalized seizures) (types of seizures refer to the classification of seizures published by ILAE in 2017); 3. Not taking antiepileptic drugs; 4. 24-hour video EEG and head MR examination within 3 months before enrollment; 5. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic constitution or allergic to the experimental drug perampanel, levetiracetam and excipients; 2. Pregnant, breastfeeding women or those who plan to become pregnant in the near future and who are unwilling to use contraceptive measures; 3. Suspect or have a history of alcohol or drug abuse; 4. Take any immunosuppressant, narcotic analgesics, and tranquilizers <=28 days before screening; 5. Patients with other mental illnesses who are unable or unwilling to cooperate; 6. Any one of the laboratory test indicators before screening meets the following criteria: admission blood routine prompts: white blood cells are less than the upper limit of the normal value (refer to the normal range of laboratory tests in the hospital); other clinically significant laboratory test abnormalities have been confirmed by the investigator. It is judged that it is not suitable to be included in the group. 7. The expected survival period is less than 3 months; 8. Diagnosis of autoimmune encephalitis within 3 months; 9. Those who have participated in other clinical trials within 3 months before enrollment; 10. The researchers believe that the patients should not participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Seizure-free rate;

Secondary

MeasureTime frame
Treatment retention time;Incidence of adverse drug reactions;Psychometric scale scores;Drug dose level of no seizure;Epileptic seizure type, type, degree;

Countries

China

Contacts

Public ContactShe Yingfang

The Seventh Affiliated Hospital, Sun Yat-Sen University

doctorshe@163.com+86 18938833965

Outcome results

None listed

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