A Phase 2b Study of BNC210 Tablet Formulation in Adults with Post-Traumatic Stress Disorder (PTSD)
Research type
Research Study
Full title
A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults with Post-Traumatic Stress Disorder (PTSD).
IRAS ID
1006356
Contact name
Ibrahim Khan
Contact email
Sponsor organisation
Bionomics Limited
Eudract number
2022-002738-15
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to assess the effects of a drug called BNC210 on the severity of symptoms in patients diagnosed with Post-Traumatic Stress Disorder (PTSD).
PTSD may result from exposure to a traumatic event during which a person experienced, witnessed, or was confronted with the actual threat of death or serious injury, or the threat to physical integrity to self or others. People with PTSD continue to experience adverse effects of their exposure to trauma for years afterwards, when the trauma is no longer present.
Treatment options for PTSD include psychotherapy (talking therapy) or the use of medications. Only two medications, the antidepressants Paxil® (paroxetine) and Zoloft® (sertraline), are approved for the treatment of PTSD, but they may take several weeks to show any effect, may not be effective in treating the full range of PTSD symptoms, and the complete remission of symptoms is rarely seen. Other treatments that are often prescribed have significant safety risks and can become addictive. Therefore, there is a need for improved medications for PTSD that are fast acting and have fewer side effects.
Participation in this study will last approximately 18 weeks where participants will be required to attend up to 7 study visits in person. During study participation, participants will be required to undergo routine medical tests, and answer and complete various questionnaires about their condition. They will be required to take the study drug twice a day for 12 weeks.
The study will enrol approximately 200 participants in total. Approximately 30-40 of these will be enrolled at designated clinical research units in England.
The study is being funded by Bionomics Limited, an Australian biotechnology company.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0691
Date of REC Opinion
10 Nov 2022
REC opinion
Further Information Favourable Opinion