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Effectiveness of verapamil in patients with carbamazepine-resistant epilepsy

Effectiveness of verapamil in patients with carbamazepine-resistant epilepsy - Verapamil in epilepsy patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36793
Enrollment
40
Registered
2011-05-24
Start date
2010-12-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

epilepsy

Interventions

Addition of verapamil to the epilepsy medciation of patients.

Sponsors

Stichting Epilepsie Instellingen Nederland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients aged 18 years and older with a history of localization-related epilepsy of at least 2 years; - epilepsy not controlled despite the (previous) use of two or more antiepileptic drugs; - current use of carbamazepine as an antiepileptic drug, with the possible addition of no more than one other antiepileptic drug; - seizure frequency of at least 2 seizures per month; - AED serum levels in therapeutic range

Exclusion criteria

Exclusion criteria: - There was no or an uncertain diagnosis of epilepsy, based on clinical history, seizure description and/or EEG registration. - progressive neurological disease - cardiac disease (heart failure; 2nd or 3rd degree atrioventricular block; sick sinus syndrome; Wolf-Parkinson-White syndrome; sinus bradycardia) - hypotension (defined as lower systolic pressure than 100 mm Hg and/or lower diastolic prerssure than 70 mm Hg) - pregnancy

Design outcomes

Primary

MeasureTime frame
Percentage of patients with more than 50% reduction in seizure frequency during the maintenance period compared to the baseline seizure frequency

Secondary

MeasureTime frame
- number of patients withdrawing from the study due to adverse effects - MDR1 expression in peripheral blood mononuclear cells prior and following verapamil administration

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)