An Open-Label, Multicenter, Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of UCB0942 When Used As Adjunctive Therapy For Partial Onset Seizures In Adult Subjects With Highly Drug-Resistant Focal Epilepsy
- Conditions
- epileptic seizuresfocal epilepsy10039911
- Registration Number
- NL-OMON50315
- Lead Sponsor
- CB Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
- Subject must have completed V13 of the Outpatient Maintenance Period of
EP0069 to be eligible for enrollment into EP0073.
- In EP0069, the subject demonstrated a reduction in frequency and/or severity
of seizures as compared to baseline that is considered clinically significant
by the Investigator and significant by the subject.
- In EP0069, the subject experiences substantial benefit from UCB0942 with
acceptabletolerability according to the subject and Investigator.
- Male subject confirms that, during the study period and for a period of 3
months after the final dose, when having sexual intercourse with a woman of
childbearing potential, he will use a barrier contraceptive (eg, condom).
- Subject has developed a known hypersensitivity to any components of the
investigational medicinal product (IMP) as stated in this protocol during
participation in EP0069.
- Subject has any severe medical, neurological, or psychiatric condition, or
laboratory value which may have an impact on the safety of the subject.
- Subject is a woman who is pregnant or lactating.
- Subject has active suicidal ideation as indicated by a positive response
(*Yes*) to either Question 4 or Question 5 of the *Since Last Visit* version of
the C-SSRS. The subject should be referred immediately to a Mental Healthcare
Professional and must be withdrawn from the study.
- Subject has taken other (non-AED) prescription, non-prescription, dietary
(eg, grapefruit or passion fruit), or herbal products that are potent inducers
or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half-lives whichever is
longer) prior to study entry.
- Subject has an abnormality in the 12-lead ECG that, in the opinion of the
Investigator, increases the risks associated with participating in the study.
In addition, any subject with any of the following findings will be excluded:
* Prolonged QTc (Bazett*s, machine-read) interval defined as >450ms for males
and >470ms for females
* Bundle branch blocks and other conduction abnormalities other than mild first
degree atrioventricular block (defined as PR interval *220ms)
* Irregular rhythms other than sinus arrhythmia or occasional, rare
supraventricular or rare ventricular ectopic beats
* In the judgment of the Investigator, T-wave configurations are not of
sufficient quality for assessing QT interval duration
- Subject has a clinically significant abnormality on echocardiography at the
EV (V2) of EP0073.
- Subject has >2x upper limit of normal (ULN) of any of the following: alanine
aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase
(ALP), or >ULN total bilirubin (*1.5xULN total bilirubin if known Gilbert*s
syndrome) at the EV (V2) of EP0073 (V15 of EP0069). If subject has elevations
only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to
identify possible undiagnosed Gilbert*s syndrome (ie, direct bilirubin <35%).
- For enrolled subjects with a baseline result >ULN for ALT, AST, ALP, or total
bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful
elevation must be understood and recorded in the electronic Case Report form
(eCRF).
If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at
screening (ie, the value is >ULN but *2xULN at the EV [V2] of EP0073), repeat
the tests, if possible, prior to dosing to ensure there is no further ongoing
clinically relevant increase. In case of a clinically relevant increase,
inclusion of the subject must be discussed with the Medical Monitor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To evaluate the long-term safety and tolerability of UCB0942 at<br /><br>individualized doses between 100mg/day to a maximum of 800mg/day in subjects<br /><br>with highly drug-resistant focal epilepsy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate the long-term efficacy of UCB0942<br /><br>- To evaluate the effects of UCB0942 on the subject*s quality of life.</p><br>