About Research Studies

Disclaimer: The Erythromelalgia Association (TEA) lists research initiatives recruiting participants with inherited and/or primary Erythromelalgia as an information service only. The posting of research studies on this website is not an endorsement or recommendation of such studies. TEA makes no representations or warranties with respect to quality, safety, reliability, qualifications, or desirability of the studies or researchers, and specifically disclaims any other warranties, express or implied.

TEA has complied a list of research studies and clinical trials currently recruiting partners.

What Are Clinical Trials?

When a pharmaceutical or biotechnology company develops a substance it theorizes will have an effect—such as relieving the pain of IEM—it must sponsor scientific experiments to prove its effectiveness before the drug can be approved by governmental authorities for use.

These experiments are called clinical trials and they are conducted in phases.  The trials at each phase have a different purpose and help scientists answer different questions. Clinical trials are overseen by physician scientists working in university medical centers or as drug or biotechnology company researchers.

Phase I Trials

In Phase I trials, researchers test the experimental drug for the first time in a small group of “normal” people to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II Trials

In Phase II trials, the experimental drug is given to a somewhat larger group of people. Those in the study group this time must have the disease or condition the drug is intended to help so scientists can see if the drug is effective and further evaluate its safety.

Phase III Trials

In Phase III trials, the experimental drug is given to larger groups of people with the targeted condition to confirm the drug’s effectiveness, monitor side effects, and collect information that will allow the experimental drug to be used safely.

Governmental agencies like the Federal Drug Administration in the U.S. will approve the drug’s use only after Phase III trials are completed successfully.

About Research & Clinical Trials

Scientific research offers great hope to people affected by erythromelalgia. Participation in studies enables individuals to contribute directly to research that may lead to discoveries that lessen the symptoms on all EM sufferers in the future. Not all studies include treatment. Click here for important background information regarding research involving DNA testing (obtained from NORD – National Organization for Rare Disorders).

Before committing to participation in a study, TEA suggests you review all written materials presented to you by the researcher with the following questions in mind.  (If the materials do not address these questions, follow up with the researcher to obtain the answers.)

  • Why do you want me in your study?
  • What is the research about? How will this research help in treating or understanding my disorder?
  • What do I need to do and how much time will this take?
  • How might this study help me, my relatives, or other people with my disorder?
  • What possible risks are there to me if I take part?
  • Could my symptoms become worse during the study? What will happen if it does?
  • What will happen to me at the end of the study?
  • What should I do if I want to drop out of the study?
  • May I get back to you after I discuss this with my family/friend/case manager/doctor?