A Phase 2 Study of CX-8998 in Adolescents and Young Adults With Generalized Epileptic Syndromes With Absence Seizures
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|ClinicalTrials.gov Identifier: NCT03406702|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : July 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: CX-8998||Phase 2|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||February 25, 2018|
|Estimated Primary Completion Date :||November 25, 2018|
|Estimated Study Completion Date :||November 25, 2018|
T-type calcium channel blocker
T-type calcium channel blocker
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v4.0 [ Time Frame: Through study completion, an average of 9 weeks ]Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period.
- Changes from baseline in QTcF and other electrocardiogram parameters [ Time Frame: Baseline through study completion, an average of 5 weeks ]Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.
- Changes from baseline in clinical safety laboratory assessments [ Time Frame: Baseline through study completion, an average of 5 weeks ]Clinical safety laboratory assessments will include chemistry and hematology. Urinalysis to be performed only as clinically indicated. Additional lab tests are obtained at the screening visit to verify eligibility (including HIV, Hepatitis B and C).
- Number (%) of subjects who did not complete the study due to Treatment Emergent Adverse Events as assessed by CTCAE v4.0 [ Time Frame: Duration of study, an average of 9 weeks ]Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period.
- Number (%) of subjects with Serious Adverse Events as assessed by CTCAE v4.0 [ Time Frame: Duration of study, an average of 9 weeks ]Any adverse event that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect observed in any offspring of the subject conceived during treatment with the study drug or is an important medical event.
- Number (%) of subjects with Adverse Events of Special Interest as assessed by CTCAE v4.0 [ Time Frame: Duration of study, an average of 9 weeks ]An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: The "lifetime" version of the C-SSRS will be used at screening, and the "since last visit" version at all other visits. The C-SSRS will be evaluated by the visiting nurse at Day 8 and Day 20 ]C-SSRS is a suicidal ideation rating scale which identifies behaviors that may be indicative of an individual's intent to commit suicide. The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406702
|Contact: Ryan O'Marafirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Tara Mctigue email@example.com|
|Principal Investigator: Selim Benbadis, MD|
|United States, Georgia|
|Center for Rare Neurological Diseases||Recruiting|
|Norcross, Georgia, United States, 30093|
|Principal Investigator: Daniel Tarquinio, MD|
|United States, Kentucky|
|Bluegrass Epilepsy Research, LLC||Recruiting|
|Lexington, Kentucky, United States, 40504|
|Contact: Amber Clark 859-313-4210 AmberClark@sjhlex.org|
|Principal Investigator: Toufic Fakhoury|
|United States, Maryland|
|Mid-Atlantic Epilepsy and Sleep Center||Recruiting|
|Bethesda, Maryland, United States, 20817|
|Contact: Arkady Barber 301-530-9744 firstname.lastname@example.org|
|Principal Investigator: Pavel Klein, MD|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Lindsey Soll email@example.com|
|Principal Investigator: Joel Oster, MD|
|United States, New York|
|NYU Comprehensive Epilepsy Center||Not yet recruiting|
|New York, New York, United States, 10016|
|Contact: Stephanie Tenzigolski 646-558-0893 firstname.lastname@example.org|
|Principal Investigator: Jocelyn Cheng, MD|
|United States, Ohio|
|Cincinnati Children's Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Peggy Clark Peggy.Clark@cchmc.org|
|Principal Investigator: Gewalin Aungaroon, MD|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Jessica Rinaldi 215-955-4672 email@example.com|
|Principal Investigator: Michael Sperling, MD|
|Study Director:||Stacey Boyer, PhD||Cavion, Inc.|