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A clinical trial to study the effect of slow and rapid withdrawal of antiepileptic drugs in patient with epilepsy in epilepsy monitoring unit

Randomized Controlled study evaluating the effect of Rapid Versus slow withdrawal of antiepileptic drugs (AEDs) in epilepsy monitoring unit (EMU)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007207
Enrollment
140
Registered
2016-08-18
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- drug refractory epilepsy patient admitted in epilepsy monitoring unit

Interventions

Intervention1: antiepileptic drugs: Rapid withdrawal of antiepileptic drugs: dose of drugs will be decreased daily by 30-50%. Detail mentioned in protocol summary. Control Intervention1: antiepileptic

Sponsors

Prof Manjari Tripathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients admitted in epilepsy monitoring unit (EMU) •Patient giving consent

Exclusion criteria

Exclusion criteria: •Patient not giving Consent. •Patients having history of status epilepticus and Seizure frequency more than 1/day •Patient with significant non- neurological co-morbidities like chronic cardiac, renal and other systemic diseases.

Design outcomes

Primary

MeasureTime frame
Difference in the duration of long-term video-EEG completion time between rapid and slow AED taper groups.Timepoint: Time points will be calculated as total days patient admitted in epilepsy monitoring room.

Secondary

MeasureTime frame
long term video-EEG diagnostic yield (calculated as a percentage of prerecording question answered upon completion of LTM) in both groupsTimepoint: Time points will be calculated as total days patient admitted in epilepsy monitoring room.;The percentage of patient with ictal onset EEG localization in two groupsTimepoint: Time points will be calculated as total days patient admitted in epilepsy monitoring room.;The percentage of secondary GTCS (sGTCS), 4-hr and 24-hr cluster, status epilepticus, need for midazolam rescue treatment and LTM associated complications in two groupsTimepoint: Time points will be calculated as total days patient admitted in epilepsy monitoring room;The time to first seizure in two groupsTimepoint: Time points will be calculated as total days patient admitted in epilepsy monitoring room.

Countries

India

Contacts

Public ContactProf Manjari Tripathi

All India Institute of Medical Sciences, new delhi

drshambhu03@gmail.com9968969092

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 8, 2026