Skip to content

To investigate the effect of early antiepileptic drugs (AEDs) withdrawal over late antiepileptic drugs (AEDs) withdrawal after pediatric epilepsy surgery

A Randomized controlled trial (RCT) on early antiepileptic drugs (AEDs) withdrawal versus late antiepileptic drugs (AEDs)after pediatric epilepsy surgery - TTTT (Time To Taper Treatment) Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/11/004122
Enrollment
180
Registered
2013-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- AEDs withdrawal after pediatric epilepsy surgery

Interventions

Intervention1: Early AEDs Withdraw: withdrawing of AEDs will be started from 6 months after surgery. Control Intervention1: Late AEDs Withdrawal: Reduction of AEDs will be started at 12 months after s

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients who underwent for pediatric epilepsy surgery. 2. Age less than and equal to 18 years. 3. Both the physician, parents And patients, if capable will agree with randomization for participation. 4. Postoperative seizure freedom achieved. 5. Agree to follow-up.

Exclusion criteria

Exclusion criteria: 1) Age greater than 18 years. 2) The treating physician/patient will not agree to discontinue all AEDs within given time frame. 3) Disagree to tapering of AEDs. 4) EEG abnormal except in persons who have undergone hemispherotomy. 5) All Patients who will not give consent for participation and not agree for follow-up. 6) All patients whose treating physician or parents decided to taper their drug treatment despite continuing postoperative seizures, including auras.

Design outcomes

Primary

MeasureTime frame
Primary outcome will be measured for seizure recurrence and seizure outcome during or after AEDs withdrawal by ILAE (International League Against Epilepsy)/ Engel scale in both groups and compare the neuropsychological measures between the two withdrawal group at preoperatively (p1), post-operatively (p2) 12 months and 18 months (p3)Timepoint: 6 monthly follow-up and up-to 60 months

Secondary

MeasureTime frame
Secondary outcome will be measure the quality of life, behavior and cognition during and after AEDs withdrawal which affect the seizure outcome.Timepoint: 6 monthly follow-up upto 60 months

Countries

India

Contacts

Public ContactRekha Dwivedi

All India Institute of Medical Sciences

manjari.tripathi1@gmail.com

Outcome results

None listed

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