Enrolling by invitation NCT07287163
Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vormatrogine.
- Who it may be relevant to
- Registry conditions: Epilepsy, Tonic-Clonic, Focal Seizure, Primary Generalized Seizure. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, Germany, Italy, Poland +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
Overview
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
Detailed description
An open label extension clinical trial to assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
Interventions
- Drug vormatrogine
Once daily oral
Primary outcome measures
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures [Time frame: Up to 2 years]
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures [Time frame: Up to 2 years]
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures [Time frame: Up to 2 years]
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures [Time frame: Up to 2 years]
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures [Time frame: Up to 2 years]
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures [Time frame: Up to 2 years]
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures [Time frame: Up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Praxis Research Site — Miami
- Praxis Research Site — Miami Lakes
- Praxis Research Site — Naples
- Praxis Research Site — Lafayette
- Praxis Research Site — Bethesda
- Praxis Research Site — Plymouth
- Praxis Research Site — Chesterfield
- Praxis Research Site — Hackensack
- … and 7 more centers
Italy · 8 centers
- Praxis Research Site — Pozzilli
- Praxis Research Site — Bosisio Parini
- Praxis Research Site — Milan
- Praxis Research Site — Naples
- Praxis Research Site — Pavia
- Praxis Research Site — Pisa
- Praxis Research Site — Ponderano
- Praxis Research Site — Roma
Spain · 5 centers
- Praxis Research Site — Barcelona
- Praxis Research Site — Madrid
- Praxis Research Site — Málaga
- Praxis Research Site — Terrassa
- Praxis Research Site — Valencia
Poland · 4 centers
- Praxis Research Site — Bydgoszcz
- Praxis Research Site — Katowice
- Praxis Research Site — Lublin
- Praxis Research Site — Warsaw
Brazil · 2 centers
- Praxis Research Site — Porto Alegre
- Praxis Research Site — São José do Rio Preto
Germany · 2 centers
- Praxis Research Site — Bielefeld
- Praxis Research Site — Tübingen
Identifiers
NCT: NCT07287163 · PRAX-628-323