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Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

NCT07287163

Enrolling By InvitationPhase 3

Sponsor: Praxis Precision Medicines

Conditions: Epilepsy, Tonic-Clonic, Focal Seizure, Primary Generalized Seizure

Interventions: vormatrogine

Countries: United States, Brazil, Germany, Italy, Poland, Spain

Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (36)

Miami, Florida, United States
Miami Lakes, Florida, United States
Naples, Florida, United States
Lafayette, Louisiana, United States
Bethesda, Maryland, United States
Plymouth, Michigan, United States
Chesterfield, Missouri, United States
Hackensack, New Jersey, United States
Amherst, New York, United States
Middletown, New York, United States
New York, New York, United States
Niagara Falls, New York, United States
Philadelphia, Pennsylvania, United States
El Paso, Texas, United States
Houston, Texas, United States
Porto Alegre, Rio Grande do Sul, Brazil
São José do Rio Preto, São Paulo, Brazil
Bielefeld, Germany
Tübingen, Germany
Pozzilli, Isernia, Italy
Bosisio Parini, Lecco, Italy
Milan, Italy
Naples, Italy
Pavia, Italy
Pisa, Italy
Ponderano, Italy
Roma, Italy
Bydgoszcz, Poland
Katowice, Poland
Lublin, Poland
+ 6 more on CT.gov