Calendario›VTGN›AV-101
AV-101
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
Ensayo de Vistagen Therapeutics, Inc. en Parkinson Disease · Dyskinesia, Medication-Induced · L-Dopa Causing Adverse Effects in Therapeutic Use (del registro, en inglés).
Más ensayos de: Enfermedad de Parkinson.
- Fase
- Fase 2
- Estado
- Sin noticias del promotor
- Participantes
- 20
- Fin del objetivo primario
- dic 2023
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en ago 2022.
Qué mide
Unified Dyskinesia Rating Scale (del registro, en inglés) (14 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia. The trial will be conducted in two treatment periods, in which each treatment period will consist of 14 days. The two treatment periods will be separated by a 1-week washout period. During the first treatment period, subjects meeting all eligibility criteria will be randomly assigned to receive either 1440 mg AV-101 or placebo in a 1:1 ratio. AV-101 or placebo will be administered BID for 14 days (every 12 hours). After the washout period, all subjects will be crossed over to receive the alternate treatment during the second treatment period (14-day period). On the last day of each treatment period (Visit 4 \[Day 14\] and Visit 7 \[Day35\]), subjects will be assessed in clinic while in the practically "off" state and will receive the morning dose of the study drug at the clinic. This will be followed, within 25-30 minutes, by oral administration of a dose of levodopa that is 150% of the subject's normal dose. Assessments of dyskinesia and PD motor symptoms will be performed before and after levodopa/carbidopa administration.
Más ensayos de VTGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Fasedienol Nasal Spray · PALISADE-3 | Fase 3 | En marcha, sin reclutar | oct 2025 (real) |
| Fasedienol Nasal Spray | Fase 2 | Reclutando pacientes | abr 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Fasedienol Nasal Spray · PALISADE-4 | Fase 3 | En marcha, sin reclutar | abr 2026 (real) |
| PH94B | Fase 2 | Completado | dic 2022 (real) |
| PH94B | Fase 3 | Interrumpido | sep 2022 (real) |
| AV-101 | Fase 1 | Sin noticias del promotor | sep 2022 (prevista, ya pasada: sin actualizar en el registro) |
Todos los de VTGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04147949), actualizada en may 2021.