A study to investigate the efficacy and safety of BHV-7000 in adults with refractory focal epilepsy.
Zusammenfassung der Studie
There are already treatments for seizures, called anti-seizure medications (ASM). However, many people with focal epilepsy continue to have seizures even while being treated with ASM. This is referred to as refractory focal epilepsy. When seizures are not controlled by medication, they can lead to injuries, difficulties in school or work, and loss of freedom. Even when seizures are under control, ASM often have side effects that affect patients' quality of life. This study aims to investigate whether a new drug called BHV-7000 reduces seizures in adults with refractory focal epilepsy and whether it is safe to use. BHV-7000 is not yet approved for the treatment of focal seizures in Switzerland. Participants will take part in the study for a period of up to 22 weeks (about five and a half months) and will need to visit the trial center about 7 times for a study visit. The study consists of 3 phases: 1. Observation period: 8 weeks, during which participants will only take the previously prescribed anti-seizure medications 2. Treatment period: 12 weeks of treatment with BHV-7000 or placebo, once daily, in addition to the previously prescribed anti-seizure medications 3. Follow-up period: 2 weeks after the last dose of BHV-7000 or placebo, participants will only take the previously prescribed anti-seizure medications. Participants who complete this study and are eligible may potentially participate in a long-term safety study where they may continue to receive BHV-7000.
(BASEC)
Untersuchte Intervention
This is a randomized, double-blind, placebo-controlled study. "Randomized" means that a computer randomly assigns participants to either a treatment with BHV-7000 or a placebo. A "placebo" is a tablet that contains no active ingredients. "Double-blind" means that neither the participants nor the study doctors know which treatment a participant will receive.
Both BHV-7000 and the placebo are administered as tablets to be swallowed.
(BASEC)
Untersuchte Krankheit(en)
Refractory focal epilepsy, a form of epilepsy where seizures begin in one part of the brain and cannot be well controlled despite treatment with antiepileptic drugs.
(BASEC)
1. Male and female adults aged between 18 and 75 years with a diagnosis of focal epilepsy 2. In the 3 months prior to the start of the study, an average of at least 4 focal seizures per month 3. Current treatment with at least 1 and up to 3 ASM at a stable dose as part of no more than 4 stable epilepsy treatments (including dietary therapy and neurostimulation) (BASEC)
Ausschlusskriterien
1. Any other type of seizures other than focal seizures, such as myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) or absence seizures (brief loss of attention or staring into space), in the past 2. Symptomatic seizures occurring for known reasons (e.g., drug or alcohol use or withdrawal, traumatic brain injury, infections, etc.) 3. Participation in other clinical studies (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Biohaven Therapeutics, Ltd. c/o Biohaven Pharmaceuticals, Inc. 215 Church Street New Haven, CT 06510 USA and PPD Switzerland GmbH c/o Dufour Treuhand AG Nicole Kayser Tiergartenrain 3, 4054 Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Lukas Imbach
+41443876302
lukas.imbach@clutterkliniklengg.chSchweizerisches Epilepsiezentrum, Klinik Lengg, AG Bleulerstrasse 60 8008 Zürich
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
05.07.2024
(BASEC)
ICTRP Studien-ID
NCT06132893 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Phase-II/IIIStudie zur Bewertung der Wirksamkeit, Sicherheit und Verträglichkeit von BHV-7000 bei Studienteilnehmer*innen mit refraktärer fokaler Epilepsie (BASEC)
Wissenschaftlicher Titel
A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy (ICTRP)
Öffentlicher Titel
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy (ICTRP)
Untersuchte Krankheit(en)
Focal Epilepsy (ICTRP)
Untersuchte Intervention
Drug: BHV-7000Drug: BHV-7000Drug: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Key Inclusion Criteria:
1. Male and Female participants 18 to 75 years of age at time of consent.
2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined
by 2017 International League Against Epilepsy (ILAE) Classification and based on
requirements of Epilepsy Adjudication criteria.
a. Focal seizures i. Focal aware seizures with clinically observable signs and/or
symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic
seizures
3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of
adequate trials of two tolerated and appropriately chosen and used anti-seizure
medication (ASM) schedules (whether as monotherapies or in combination) to achieve
sustained seizure freedom.
4. Ability to keep accurate seizure diaries
5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in
total
Key Exclusion Criteria:
1. History of status epilepticus (convulsive status epilepticus for > 5 minutes or
focal status epilepticus with impaired consciousness for > 10 minutes) within the
last 6 months prior to screening visit that is not consistent with the subject's
habitual seizure.
2. History of repetitive/cluster seizures (where individual seizures cannot be counted)
within the last 6 months prior to screening visit and during observation phase.
3. Resection neurosurgery for seizures <4 months prior to the screening visit.
4. Radiosurgery performed <2 years prior to the screening visit.
5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or
psychic phenomena only, without impairment of consciousness or awareness (formally
called simple partial seizures), with or without ictal EEG correlation with clinical
symptoms.
6. Any condition that would interfere with the subject's ability to comply with study
instructions, place the subject at unacceptable risk, and/or confound the
interpretation of safety or efficacy data from the study, as judged by the
Investigator (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Change from Baseline in 28-day average seizure frequency (ICTRP)
Percentage of Participants with at at least 50% reduction in seizure frequency per month;Change from Baseline in 28-day average seizure frequency during first month of treatment;Percentage of Participants with at at least 75% reduction in seizure frequency per month;Percentage of Participants with seizure freedom during DB Phase;Change from baseline in 7-day adjusted seizure frequency during first week of treatment;Change from baseline in Patient Global Impression of Change (PGI-C);Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs;Number of Participants With Clinically Significant Laboratory Abnormalities (ICTRP)
Registrierungsdatum
10.11.2023 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Chief Medical Officer, clinicaltrials@biohavenpharma.com, 203-404-0410 (ICTRP)
Sekundäre IDs
2023-508539-30, BHV7000-302 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06132893 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar