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Clinical trial of Staccato® Alprazolam in study participants 12 years of age or older with prolonged stereotyped epileptic seizures

YOU ARE BEING INVITED TO PARTICIPATE IN THIS CLINICAL RESEARCH STUDY BECAUSE YOU HAVE A SPECIFIC TYPE OF EPILEPSY WITH PREVIOUS EPISODES OF PROLONGED SEIZURES AND HAVE PREVIOUSLY PARTICIPATED IN A PREVIOUS STUDY OF STACCATO® ALPRAZOLAM (I.E., EP0162, ENGAGE-E-001 OR UP0100). EPILEPSY IS A DISORDER OF THE CENTRAL NERVOUS SYSTEM IN WHICH BRAIN ACTIVITY BECOMES ABNORMAL, RESULTING IN SEIZURES OR PERIODS OF ABNORMAL BEHAVIOR OR SENSATIONS, AND SOMETIMES LOSS OF CONSCIOUSNESS. THE PURPOSE OF THIS STUDY IS TO EVALUATE THE LONG-TERM EFFECT AND SAFETY OF STACCATO® ALPRAZOLAM IN EPILEPTIC PATIENTS WITH PREVIOUS EPISODES OF PROLONGED SEIZURES, AS IN YOUR CASE.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

Technical Summary

  • OPEN-LABEL, MULTICENTER, OUTPATIENT, EXTENSION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF STACCATO® ALPRAZOLAM IN STUDY PARTICIPANTS 12 YEARS OF AGE OR OLDER WITH PROLONGED STEREOTYPIC SEIZURES
  • Code EudraCT: 2021-002637-42
  • Protocol number: EP0165
  • Promoter: UCB Biopharma SRL
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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