About the Study

 

Are you suffering from sciatica or leg pain from a herniated disc?
Explore a nonsteroidal, non-opioid option other than surgery.
Consider The Discovery 6603 Study. See if you prequalify.


The Discovery 6603 Study is a clinical research study examining the effectiveness of an investigational drug injection. You may be eligible to participate in the study if you are:

Experiencing sciatica or pain in a single leg which has not lasted for more than 12 months
Age 30 to 70
< 40 BMI
Can stop taking opioid and remain off for the duration of the study
Not receiving worker's compensation
Other criteria may apply

The study drug, SI-6603 is approved for use in Japan for the treatment of lumbar disc herniation, launched with the brand name "Hernicore®" in August 2018, and 2158 vials have been sold as of May 2019*. SI-6603 is an investigational product in the United States and is not yet approved by the Food and Drug Administration. The graph below shows data obtained in the past clinical study in Japan, which indicates the efficacy of the study medication. When compared to placebo, condoliase (SI-6603) improved pain remarkably, gradually starting from 1 week after injection and reached maximum improvement at around 3 months after injection. In addition, improvement effect lasted until end of the study (1 year after injection).

*ⓒ2019 IMS Health Calculated based on 2019 May MAT, JPM, Reprinted with permission

chart of treatment effect in patients

To prequalify, each person will be asked questions about their leg and back pain, medications being taken and any side effects that might have been experienced.

All study participants will be monitored by the study doctors and staff for the duration of the study. They will collect blood and urine samples for laboratory testing. Participants will also receive an MRI and X-Ray. Each study participant will be provided with an electronic device on which they can record their pain condition and medication used on a daily basis. Participants will not be allowed to use opioids or cannabis during the study. Other pain medication may be available if needed.

To see if you qualify call 877.770.1411

or

For more information on the study, visit: https://clinicaltrials.gov/ct2/show/NCT03607838