STX209 – You’ve heard of it, right?

We here at Chez Monkey are very excited that there will be a nearby clinic for Seaside Therapeutics’ Phase III STX209 trial. We have spoken to the researcher at UMASS in Worcester and he’s given us the OK to share with you what he told us in our screening call. Duhdee and I are still discussing our participation, that’s a separate post though.

The screening call took about 30 minutes, it could take longer if you have more questions or if your child has more health concerns, Monkey is a healthy boy so we skimmed past most of those pretty quickly.

This first call is to establish preliminary eligibility. If you make it past this call, you will go to the study site for additional screening. So, 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. There are some that are not being allowed, SSRIs are a biggie ((This is where Duhdee and I stumbled.)). Don’t assume you won’t be able to work around this though, the study Dr’s are willing to talk to your child’s prescribing physician if you are willing.
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.

If you make it through the screening call you will have to go to the study site for additional screening. The additional 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 ((He said it was not painful, I could not help myself and replied that Monkey has a different definition of painful than he does, lol.)).
5. Filling out behavioral questionnaires ((Of course, do any of us ever go to any appointment and NOT have to do this??)).
6. A blood draw. He assured us the nurses they use are very nice and very patient.

So…you made it all the way through and you are enrolled in the clinical trial. Now what?

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 in the next two weeks. They have the trial drug on hand and they’ve cleared their ethics requirements, it’s just down to the nitty, gritty, administrative stuff.

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 you will not get the study drug. Once the trial is complete, however, you 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.

That is about it. It’s not an easy process but it wasn’t terribly painful either (so far, at least.) Duhdee and I are still talking it over and will be sending a follow up e-mail with some additional questions. 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.

Michael Hill is stepping aside, the new contact is below!

You can reach Mike Kara at:

Michael Hill Kara Manchester
Research Coordinator
University of Massachusetts Medical School
Biotech I, Suite 100
365 Plantation St. Worcester, MA 01605
Phone: 508-856-2041 508-856-2789
Fax: 508-856-8211
Research Line: 508-856-5896
Email: Michael.Hill@umassmed.edu Kara.Manchester@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.

And, I don’t really think this needs to be said but, Duhdee and I have no affiliation with Seaside Therapeutics. We are vocal supporters but we are not, in any way, compensated by them or anyone else for talking about this process. We encourage you to reach out to them and think about it but we still may very well come down on the “No, thanks” side ourselves. If we do, though, it will be a pretty big disappointment for us…we really want to do this but it’s all about Monkey’s best interests. Obviously.