Calendario›SUPN›SPN-810
SPN-810
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Ensayo de SUPERNUS PHARMACEUTICALS, INC. en Attention Deficit Hyperactivity Disorder (ADHD) (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 297
- Centros
- 32
- Fin del objetivo primario
- nov 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2016.
Qué mide
Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary (Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.
Más ensayos de SUPN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| apomorphine infusion · INFUS-ON | Fase 3 | En marcha, sin reclutar | dic 2018 (real) |
| SPN-812 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| BIS-001ER · FIAS | Fase 1/2 | En marcha, sin reclutar | dic 2026 (prevista) |
| SPN-821 2400 mg | Fase 2 | Reclutando pacientes | dic 2026 (prevista) |
| SPN-817 | Fase 2 | Reclutando pacientes | ago 2027 (prevista) |
| Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: | no aplica | Reclutando pacientes | ago 2027 (prevista) |
Todos los de SUPN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02618434), actualizada en mar 2024.