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A randomized, double-blind, controlled, multicenter clinical trial to observe the efficacy and safety of combination therapy versus monotherapy in newly diagnosed adult focal epilepsy

A randomized, double-blind, controlled, multicenter clinical trial to observe the efficacy and safety of combination therapy versus monotherapy in newly diagnosed adult focal epilepsy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048530
Enrollment
Unknown
Registered
2021-07-09
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

epilepsy

Interventions

Intervention group:Combination of valproate and carbamazepine
control group:Combination of valproate-placebo and carbamazepine

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Onset in adulthood (>= 18 years old), male or female; 2. Interval > 24h, >=2 times, non induced focal seizures (with or without progressive bilateral tonic clonic seizures, seizure types refer to the epilepsy classification published by ILAE in 2017); 3. Never taking antiepileptic drugs; 4. VEEG and MR examination were performed within 3 months before admission; 5. HLA-B * 1502 allele screening was negative; 6. Obtain informed consent.

Exclusion criteria

Exclusion criteria: 1. Reflex epilepsy; 2. Lactating women; 3. AEDs treatment was started before the trial; 4. Weight < 40 kg; 5. Take any immunosuppressant, antipsychotic, monoamine oxidase inhibitor or narcotic analgesics <= 28 days before screening; 6. Attempted suicide, chronic alcohol or drug abuse within 2 years before screening; 7. Status epilepticus within 3 months before screening; 8. Accompanied with progressive diseases of nervous system (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, mitochondrial encephalomyopathy, motor neuron disease, etc.); 9. Organic heart disease or arrhythmia (especially atrioventricular block); 10. Liver and kidney dysfunction; 11. Patients with sleep disorders should take diazepam drugs to assist sleep; 12. Women with positive pregnancy test; 13. Men and women who plan to have children in the near future.

Design outcomes

Primary

MeasureTime frame
Seizure free rate;

Secondary

MeasureTime frame
Treatment retention time;drug dose levels of seizure free;types and degrees of epileptic seizures;

Countries

China

Contacts

Public ContactZhou Liemin

The Seventh Affiliated Hospital, Sun Yat-sen University

lmzhou56@163.com+86 13802755530

Outcome results

None listed

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