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Taking people in GermanyPhase 3

Long-term safety study of vormatrigine in adults with epilepsy

Checks the safety of vormatrigine in adults with focal or generalized tonic-clonic seizures.

Key facts

Who runs it
Praxis Precision Medicines Inc.
Where
Bielefeld, Bonn, Frankfurt Am Main, Marburg, Osnabrueck, and Tuebingen, GermanySee the 6 sitesAlso in 3 other countries, 38 sites
Registry title
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
Status
Recruiting
Phase
Phase 3
People taking part
56 people, planned
Started
16 Oct 2025
Expected to end
1 Sept 2027
Type of study
Interventional
Record updated
29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with focal or primary generalized tonic-clonic seizures who already took part in an earlier vormatrigine trial or received vormatrigine outside a trial.

Age
18 years or older
Sex
Men and women can join.
Disease stage
Focal onset seizures or primary generalized tonic-clonic seizures.
Earlier treatment
Must have finished an earlier vormatrigine trial (such as PRAX-628-212 or PRAX-628-321), or have received vormatrigine outside a trial, for example in an expanded access program.

Main reasons for not taking part

  • Stopped or left the treatment period of an earlier trial, unless the sponsor accepts it
  • Plans to join another interventional study
  • Takes a prohibited medication listed in Table 7
  • Is pregnant, breastfeeding or planning to become pregnant
  • Did not keep an adequate seizure diary or did not take vormatrigine as planned

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Participant and caregiver (if applicable), is willing to sign an informed consent document in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, indicating that they understand the purpose of the clinical trial; understands and can perform, complete, and comply with all the procedures and assessments that are required during the clinical trial, including the seizure diary and contraception, and is willing to participate in the clinical trial
  • Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trial, 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

Who cannot take part

  • Participant who plans to enter another interventional investigational study or is on any prohibited medication listed in Table 7
  • Participant who withdrew or discontinued treatment from the treatment period of an eligible clinical trial unless deemed acceptable by the sponsor
  • 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

Where in Germany

Also in 3 other countries, 38 sites

  • Gesellschaft Fuer EpilepsieforschungBielefeld, GermanyTaking people
  • Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
  • Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyTaking people
  • Universitaetsklinikum Giessen und Marburg GmbHMarburg, GermanyTaking people
  • Klinikum Osnabrueck GmbHOsnabrueck, GermanyTaking people
  • Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people

About the trial

What the trial wants to find out

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
Plain-language title
Long-term safety study of vormatrigine in adults with epilepsyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
29 October 2026