What the Medication?
This phase 3 clinical study will be testing an investigational medication called Balovaptan, to determine whether this can block a hormone receptor in the brain which has been linked to challenging symptoms associated with autism such as socialisation, anxiety, stress and aggression.
The medication comes in tablet form and is taken once a day.
About the V1ADUCT Study
Clinical studies all vary in length, depending on the condition and type of medicine being testing. The V1ADUCT consists of 4 phases as outlined below:
The V1ADUCT study commences with a screening period which can take up to 4 weeks. Potential volunteers will have the opportunity to learn all about the trial and if they consent to participate, trial assessments will be conducted throughout this period
Study volunteers will be given the medication, which they will take over a 24 week period. Half of the participants will be given the active medication and the remaining participants will be given a placebo, a look-alike tablet which doesn’t contain the active medicine. Neither the active nor the placebo group will know which medication they are taking, nor will the study team. This is known as “double-blind” testing and will ensure that any changes experienced by participants are due to the investigational medication and not any external factors.
- Optional Extension Period
Following the Dosing Period, all participants, whether they were in the active or placebo group, will have the opportunity to take the active medication (balovaptan) for the following 2 years.
Participants will be required to attend a follow up appointment 12 weeks after the final dose so a health check can be conducted.
We are dedicated to prioritising the health and safety of all of our study volunteers and therefore require all participants to have regular, monthly health checks at the clinical trials clinic, so our team can assess how individuals are responding to the medication. Individuals who decide to join the extension trial will also continue to be monitored on a monthly basis.
The V1ADUCT adult autism study is being conducted at the Re:Congition Health clinic in central London. Refreshments are provided and reasonable travel expenses are also reimbursed.
The safety of trial participants is our utmost priority. Participation is on a voluntary basis and volunteers are free to leave a trial at any point. For any individual wishing to leave the trial, we would ask you arrange a final health check with our Clinic.
Advantages of clinical trials
Clinical trials are essential for the development of new medicines and there are many advantages in taking part in clinical studies:
- Volunteers have the opportunity to gain access to new medicines before they are available on the market
- Participants will receive regular monitoring throughout the trial by a team of industry-leading, medical professionals
- There are no costs involved with being in a clinical study and reasonable travel costs are reimbursed
Why clinical trials?
Every medication on the market has been subjected to a clinical trial. Without these trials, new medications cannot be developed. Tens of thousands of people participate in clinical studies every year, helping to treat symptoms, conditions, cure disease, save lives and contribute to vital research and advance our knowledge.