A Phase 2 Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures (T-WAVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03406702|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2018
Last Update Posted : May 10, 2019
|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 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.
|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 Adults With Idiopathic Generalized Epilepsy With Absence Seizures|
|Actual Study Start Date :||February 25, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
- Epworth Sleepiness Scale (ESS) [ Time Frame: Duration of study, an average of 9 weeks ]The ESS is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for 8 different situations. The scores are added together to obtain a single number.
- University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) [ Time Frame: Duration of study, an average of 9 weeks ]The UM-PDHQ is a 20-item clinician-administered questionnaire that quantitatively and qualitatively assesses hallucinations. The UM-PDHQ will be completed for any subject who reports hallucinations
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
|United States, Arkansas|
|Arkansas Epilepsy Program|
|Little Rock, Arkansas, United States, 72205|
|United States, Florida|
|University of Florida|
|Tampa, Florida, United States, 33612|
|United States, Kentucky|
|Bluegrass Epilepsy Research, LLC|
|Lexington, Kentucky, United States, 40504|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, New York|
|NYU Comprehensive Epilepsy Center|
|New York, New York, United States, 10016|
|United States, Ohio|
|Cincinnati Children's Hospital|
|Cincinnati, Ohio, United States, 45229|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Molly Myers||Jazz Pharmaceuticals|