Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded access program)
* Participant who had adequate seizure diary and vormatrigine adherence and had been otherwise adherent to the study procedures in the opinion of the investigator unless deemed unacceptable by sponsor
Exclusion Criteria:
* Participant who withdrew or discontinued treatment from the treatment period of an eligible clinical trial unless deemed acceptable by the sponsor
* Participant who plans to enter another interventional investigational study or is on any prohibited medication
* Participant who is pregnant, lactating or planning to become pregnant
* Participant who is ineligible for the extension clinical trial in the view of the investigator
Primary outcome measure(s)
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years Change in tympanic temperature in Celsius
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years Change in heart rate in beats per minute
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years Change in blood pressure in mm/Hg
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years Change in respiratory rate in breaths per minute
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures — Up to 2 years Incidence of clinically significant ECG abnormalities
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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