Complex Regional Pain Syndrome (CRPS), also known as Reflex Sympathetic Dystrophy (RSD), is a chronic pain condition that affects many individuals. The pain from CRPS usually affects one or more of the limbs (arms, hands, legs, or feet). CRPS pain is often described as constant and intense, and it is considered the most painful form of chronic pain that exists today.
Symptoms of CRPS include:
·Intense burning pain
·Dramatic changes in skin temperature, color, or texture
·Extreme skin sensitivity
·Swelling or stiffness in the affected area
About the Study
THE CREATE-1 CLINICAL STUDY
Doctors at select centers in the U.S., U.K., and Australia are currently accepting participants for the CREATE-1 Clinical Study. The study is for an investigational medication that may help improve CRPS symptoms. If you suspect you have CRPS, or have been diagnosed with CRPS within the past 6 months, this study may be right for you.
If you choose to join the study, you will receive all study-related care at no cost, and your
CRPS condition and overall health will be closely monitored by a team of physicians and study staff. As a study participant, you will be asked to meet with your study doctor regularly over a 6-month period.
Do I qualify for this study?
Key Inclusion Criteria:
·Male or female of at least 18 years of age ·Recently confirmed diagnosis of CRPS-1
Key Exclusion Criteria:
·Received chronic opioid therapy within 4 weeks ·Received a sympathetic nerve block within 3 weeks ·Active litigation or a pending workers' compensation decision ·Any other clinically significant medical or pain condition (eg, Parkinson's disease, cognitive impairment, or fibromyalgia)
Other Study Related Information
How long does the study last?
The study lasts approximately 6 - 7 months. During this time, you will be asked to meet with your local study doctor up to 13 times to evaluate your CRPS symptoms.
I am not sure if I have CRPS. Can I still possibly join the study?
Yes, as part of the study, your local study doctor will review your symptom history, medications, and overall health to determine if you have CRPS and to confirm if you are eligible to participate.
Can I receive the study medication without joining the study?
No, the study medication is investigational and is currently only available through the CREATE-1 Clinical Study.
Are there any costs involved in the CREATE-1 Study?
If you choose to join the study, you will receive all study-related care at no cost. This includes all study medications, as well as any visits associated with the study. You will also be compensated for your time and travel to attend study visits.
What if I join the study and decide I do not want to participate anymore?
As with all clinical studies, your participation is completely voluntary and you may leave the study at any time. This will not affect your medical care or relationship with any of your doctors.