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The efficacy and safety of topiramate and valproate in treatment of Chinese patients with partial and generalised epilepsy: a multi-center, long-term follow up randomised controlled trial

The efficacy and safety of topiramate and valproate in treatment of Chinese patients with partial and generalised epilepsy: a multi-center, long-term follow up randomised controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001131
Enrollment
Unknown
Registered
2010-12-22
Start date
2006-01-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Epilepsy

Interventions

TPM Group:The initial dosage for adolescents and adults was 25 milligram twice per day, with a weekly escalation of 25 milligram per day.
VPA Group :The starting dosage of VPA for adolescents and adults was 400 mg/d, with a weekly escalation of 100mg/d until the target dosage (800-1800 mg/d) was reached. The maximum dosage was 2000 mg/d

Sponsors

Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 70 years old; 2. Patients who were definitively diagnosed with partial or generalised epilepsy. The seizure types and the types of epilepsy were defined according to the guidelines of 1981 and 1989 by the International League Against Epilepsy (ILAE); 3. Newly diagnosed epileptic patients who never received AED(s); 4. Patients who can count the number of seizure onsets; 5. The female under the child-bearing periods who used the admitted contraceptive methods; 6. Patients with clear consciousness, voluntary participation and agreed to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with progressive central neurological diseases; 2. Patients with pseudo-seizures or patients with acute sympomatic seizures; 3. Patients with contraindication of topiramate of valproate; 4. The pregnant and lactating patients; 5. Patients with sever mental retardation; 6. Patients with history of psychiatric problems; 7 Patients with clinically significant organic diseases before treatment, such as cardiovascular system problems, abnormal liver function, abnormal kidney function, abnormal haematological system function; 8. Patients with maligant tumor; 9. Patients with urinary calculus; 10. Patients who were definitively diagnosed with epilepsy syndromes.

Design outcomes

Primary

MeasureTime frame
Time from randomisation to treatment failure;Time from randomisation to the achievement of a 12-month remission;

Secondary

MeasureTime frame
The total incidence of clinically importment adverse effects;Time from randomisation to a first seizure;The total incidence of clinically importment adverse;The incidence of severe adverse effect;

Countries

China

Contacts

Public ContactXuefeng Wang
xfyp@163.com+86 23 89012878

Outcome results

None listed

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