NCT03406702

CX-8998 for Absence Seizures

A Phase 2a, Safety, Tolerability, Pharmacokinetics, and Quantitative EEG Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 16 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.

Detailed description

This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication. Subjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	CX-8998	T-type calcium channel blocker

Timeline

• Start date: 2018-02-25
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2018-01-23
• Last updated: 2022-09-08
• Results posted: 2022-09-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study