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STX209 Research Trials in Massachusetts.

Phase III Trials for Seaside Therapeutics’ STX209 are now ongoing. There is a trial site in Massachusetts this time. We had a chance to speak with Michael Hill, the Research Coordinator, at the UMASS Worcester location to discuss the trial process and decided to share it with you in case you are considering taking part and are wondering what exactly is involved.

First, there is a two part admission process. The first part is a screening call to determine if your son or daughter may be eligible to participate based on current medications and health. The second part is a visit where they will gather further information (including blood and an EKG) to determine if your son or daughter is medically eligible to participate.

The screening call took us about 30 minutes, it could take longer if you have more questions or if your child has more health concerns.

What are they looking for in this first call?

  1. Your contact info.
  2. What language your child speaks and/or understands.
  3. If the fragile X syndrome diagnosis is confirmed. (If yes, they will want a copy of the report. If no, they can do the testing as part of the screening process.)
  4. What medications your child is currently on.
  5. If your child is on a medication that is not allowed, and you and your child’s doctor decide to remove that medication…and this is VERY IMPORTANT…YOU MUST TALK TO YOUR CHILD’S DR. MUST! MUST! MUST! The period your child needs to be off the medication will vary depending on what it is. Generally, between 4 and 8 weeks.
  6. What educational interventions your child receives, if any, and when that started (PT, OT, ST, Special Education, etc.)
  7. What behavioral interventions your child receives, if any.
  8. What dietary interventions your child receives, if any.
  9. How your child does with blood draws, there are 3 during the study period.
  10. If your child ever participated in a clinical trial and how that went.
  11. Any questions or concerns you might have about any of what you’d discussed.

The study visit screening will involve…

  1. A physical exam.
  2. A medical history.
  3. A psychiatric history.
  4. An EKG. He said it was a simple EKG, non-invasive, and only takes a couple minutes.
  5. Filling out behavioral questionnaires.
  6. A blood draw.

The following is to give you an idea of the requirements if you make it through the screening and are enrolled in the clinical trial.

First, there are two age groups being included in this trial at the UMASS Worcester site. Ages 12-25, which is, as of August 30, underway and ages 5-11, which should be getting underway soon. They have the trial drug on hand and they’ve cleared their ethics requirements, it’s just down to screenings.

The trial will last about 4 1/2 months. During that time there will be 6 study visits to the Worcester location and 11 phone calls with one of the Dr’s. The phone calls will be every 4 days for the first two weeks then dropping down to once a week and eventually once every two weeks. The visits will vary in length, the phone calls should be 20 minutes or less. So, there is a time commitment required here and you will have to stay on their visit schedule.

In the ages 5-11 group, called the HARBOR-C trial, there will be 4 dosing groups:

  1. placebo
  2. 5 mg dose
  3. 10 mg dose
  4. 15 mg dose

That’s a 1 in 4 chance your son or daughter will not get the study drug. Once the trial is complete, however, your son or daughter will be given the option of receiving the full dose of the study drug until the FDA approves the drug for marketing.

In the ages 12-25 group, called the HARBOR-A trial, there will just 2 dosing group:

  1. placebo
  2. dose adjusted by doctor during a titration period

As with the HARBOR-C trial, once completed you will be given the option of receiving the full dose of the study drug.

There is room for 6-8 patients in each HARBOR trial, they’ve had a fair amount of interest but the slots are not yet full so I encourage you to make the call and talk it over.

You can reach Mike at:

Michael Hill
Research Coordinator
University of Massachusetts Medical School
Biotech I, Suite 100
365 Plantation St. Worcester, MA 01605
Phone: 508-856-2041
Fax: 508-856-8211
Research Line: 508-856-5896
Email: Michael.Hill@umassmed.edu

You can find out more information about the Worcester research group at http://www.umassmed.edu/psychiatry/candi/index.aspx.

Check out ClinicalTrials.gov for more information too. If you aren’t local to us, there are 19 other study locations, check here for a list: Clinical Trial Sites.

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