What happens if you decide to participate?
In summary, the Persica 002 trial will need a significant commitment from you:
- Several checks will be done to make sure you are suitable for the trial and not everybody will be able to enter the clinical trial;
- 2 injections of the trial drug into your spinal disc (or 2 sham injections if you are randomised to placebo, the dummy treatment) will be given over 5 days;
- You would be on the trial for up to 14 months requiring regular visits to the hospital, especially in the first 2 to 3 months;
- 3 MRI scans and blood tests during the trial;
- After the first 3 months the visits to the hospital are approximately every 3 months;
- You have to be available for phone calls at specified times during the trial;
- You will need to complete the electronic diary regularly during the trial;
- Tell your trial team about any other medicines that you take, even if it is a medicine you buy without a prescription. You are asked not to take any other medication without speaking to your trial doctor first;
- Report all experienced side effects and changes in your health;
- You cannot take long term antibiotic therapy for any reason for the duration of the trial.
- Should you need to take long term antibiotics you will need to stop taking part in this trial;
- Short courses of antibiotics are allowed after discussion with your trial doctor;
- If you are a woman, you must not be currently breastfeeding or plan to get pregnant while in the trial and for 1 month after you finish the trial.
- If you are a man, you must not cause your partner to become pregnant in the 100 days following the injection. You must agree not to donate sperm until 100 days after the injection.
You will receive:
- Persica Pharmaceuticals will supply the trial drug and pay for all procedures.
- You will be reimbursed for reasonable expenses (meals and transport) for attending the trial visits.However, there will not be any payment for participating in the clinical trial.
- You will be monitored throughout the trial.
This is a clinical research trial with a medication that has not been used this way in humans before. Furthermore, you may not get benefit from the clinical trial medication.
You should be aware that patients may be initially disappointed when they receive antibiotic treatment because they expect to get well quickly. It can take up to 12 months before your Chronic Low Back Pain is better. First the bacteria must be killed; it then takes some months for the tissues to heal and the muscles to regain their strength. Reduction in pain may be only after this process. When this happens, the patient may experience less back pain. This is why you will stay in the trial for a year to assess your progress.
When your pain slowly improves you can start gentle exercise and slowly progress within your pain limits.