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CX-8998 for Absence Seizures
Title |
A Phase 2a, Safety, Tolerability, Pharmacokinetics and Quantitative EEG Study of CX-8998 in Adolescents and Young Adults with Generalized Epileptic Syndromes with Absence Seizures |
Therapeutic Area |
Seizures
|
Principal Investigator |
Joel Oster, MD |
Min Age |
18 Years |
Max Age |
45 Years |
Gender |
Any |
Contact |
Lindsey Soll 617-636-7620
lsoll@tuftsmedicalcenter.org
|
More Information |
https://www.clinicaltrials.gov/ct2/show/NCT03406702 |
This is a 9-week, phase 2a, multicenter, double-blind, placebo-controlled, parallel-group study in young adults with generalized epileptic syndromes with absence seizures. The primary objective of the study is to determine the safety and tolerability of the study drug, CX-8998.
Inclusion Criteria
- Diagnosed with an epileptic syndrome with absence seizures.
- Absence seizures persisting despite trials with at least 2 standard anti-epileptic treatment.
- On a stable dose or one or more anti-epileptic medications for at least 30 days or not on any therapy.
Exclusion Criteria
- History of focal epilepsy for epileptiform patterns.
- History of surgical intervention for treatment of epilepsy.
- Inadequately treated psychotic or mood disorder or severe intellectual or developmental disorder.
Study Requirements
Number of research visits: 3
Number of nurse home visits: 3
Length of participation: 9 weeks
Number of blood collections: 3