Clinical Trial Available for Thyromax, New T3 Synthetic Medication By Mary Shomon

[shambles]

The U.S. National Institutes of Health is sponsoring a clinical trial, and the trial is currently recruiting participants. The trial is titled "Phase II Single Daily-Dose Response Study of a New Liothyronine Sodium (T3) Preparation With Sustained Effects in Hypothyroid Patients." The trial will be investigating the effects of ThyroMax, a sustained release synthetic T3 (liothyronine) drug as a treatment for hypothyroidism.

According to the listing at Clinicaltrials.gov, "The purpose of this study is to test a new thyroid hormone preparation. The thyroid gland produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a synthetic form of T4. T4 is converted into the active hormone T3 in the circulation. Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly lower than in individuals whose own thyroid gland is functioning normally. Symptoms of hypothyroidism have been suggested to occur because of this possible T3 deficiency, although this is controversial. Studies of T3, added to or substituted for T4 in traditional levothyroxine regimens, have generally not shown any benefit of T3. However, it is still possible that no benefit is seen because of the short duration of action or "half-life" of T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels. This study will look at TSH and thyroid hormone levels following a daily dose of a new preparation of T3 that may have longer duration of action than liothyronine. This preparation of T3 is called Thyromax® or BCT303. The investigators believe that steady levels of T3 will be seen after taking Thyromax®. The investigators believe that in patients with hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels, without producing symptoms of too much thyroid hormone. The goal of future studies is to test whether Thyromax® may be a potential treatment for hypothyroidism, by comparing it with traditional levothyroxine therapy."

Eligible patients will be:

• Hypothyroid, and taking levothyroxine (i.e, Synthroid, Levothroid, Tirosint, etc.)

• Age 18-65

• Able to make weekly in-person visits to Washington, D.C.

The study exclusion criteria include:

• Pregnant or nursing

• Have a chronic medical condition such as heart disease or any other chronic medical conditions such as lung disease (e.g. asthma), kidney disease (e.g. kidney failure), liver disease (e.g. hepatitis), diabetes, or cancer.Taking steroid medications such as estrogen, progesterone, estrogen or progesterone related medications, testosterone, or glucocorticoids

• Already taking T3

The study is being conducted at Georgetown University Hospital in Washington, DC. If you are interested in being recruited, the contact for the study is Jacqueline Jonklaas, M.D., Ph.D., 202 687 2012, email [e-mail]. Please refer to Clinical Trials Identifier # NCT01800617 for the study. You may also want to follow Thyromax at their ThyroMax Facebook page.

Here is the trail details.

clinicaltrials.gov/ct2/show...

I wonder if there was a synthetic T3 would be more available, cost less?

I also wonder if a synthetic T3 would in effect cause the same sort of problems as synthetic T4?

The idea is a good one. that One pill to substitute multiple. But nothing is ever black and white!

[Clarebear]

Most T3 is synthetic, except for that contained in NDT, I believe.

This sounds like a good idea though, although I personally doubt that a high enough dose will result in normal TSH levels. Any decent amount of T3 causes a suppressed TSH in my experience. Dosing T3 by TSH level doesn't seem possible. Hopefully they will be more guided by fT3 levels x

[shambles in reply to Clarebear]

Sorry yes, my mistake!

I was thinking that they were attempting to make a new NDT.

I guess I get too excited by the prospect of a pill that might help more especially when you have no thyroid!

[Clarebear in reply to shambles]

Let's hope it is what we have all been waiting for xx

[helvella Administrator Thyroid UK]

There is a synthetic T3! Called Liothyronine and manufactured for Amdipharm Mercury in the UK.

Rod

[shambles in reply to helvella]

Yes Rod, just me being stupid :$

[helvella Administrator Thyroid UK in reply to shambles]

And there was I thinking it was me!

Rod

[anuska]

i hopem so as welll keep me update

[vajra]

Thanks S - good to see work being done. Hopefully it'll go well, although there's a view (which may or may not hold water) that slow release T3 doesn't necessarily suit everybody.

Based on similar snippets it seems that stuff like the quantity, ratio of the hormones, and the way they are taken (spread in small doses, or in larger lots) may all make a difference - at least for quite a few of us.

That's before issues like duration of the disease/pre-existing damage and imbalances, absorbtion, adrenal status, toxicity, inherited tendencies and the like are also factored in.

This if borne out points to the likelihood that a personalised replacement regime (probably preceded by or concurrently with nutritional and similar preparatory work) helps more of us to do well.

Many clinical trials of replacement strategies it seems get set up on the basis of a 'one size fits all' replacement strategy applied to a mixture of patients and scenarios - with the results assessed and reported on a statistical basis.

This is no doubt rational if you're (presumably for commercial/logistical/other reasons - see below) seeking a magic bullet solution capable of more or less universal use in general practice, but as has often been said before it may also explain the relatively poor results seen in some trials of this sort involving the use of T3.

It's not the clearest either how these studies arrive at the hypothesis to be tested. It's hard not to think based on the realpolitik of thyroidology so far (the whole T4/TSH debacle) that commercial priorities and researcher hubris may result in a lot of pre-judgement/jumping to conclusions.

I'd love to see some case study based trials carried out. That'd be where doctors (and also patients who have already made good progress in this regard - who consequently have a lot to contribute) experienced in the holistic treatment of thyroid and related metabolic conditions worked one to one with a series of patients in controlled conditions.

With a view to identifying the replacement (and broader treatment) regime that does the best job for each patient.

This as judged by the degree of patient well being and elimination of symptoms achieved - with lab work as deemed appropriate positioned as a support in the background. Not as an ideologically driven determinant of treatments (as in the T4/TSH protocol), but to help measure and understand what's happening during replacement and other treatments, and as a part of a drive to understand the parameters determining metabolic well being and freedom from symptoms.

I can't help feeling that if researchers would just take the time to truly listen - to first understand on a patient by patient basis what really works and what doesn't that it would achieve so much.

It would greatly increase the likelihood of success in the next stage - finding more generalised stock solutions (or of at least defining effective treatment treatment protocols) that also work....

ian

[diogenes Remembering]

I welcome this study, but only as a starting probe study to examine the relation between health, T3 and TSH. I am a strong believer in slow-release thyroid hormone supplementation for hypothyroid patients, but preferably a T4/T3 combination so as to mimic the natural state of affairs and try to restore the original balance unique to the patient when well . The problem with one dose of T3 alone is that any given dose may be OK for some parts of the body, too little for others and too much for yet others. T4/T3 combined would allow a much better control situation, because those parts of the body requiring more could get it from T4-T3 conversion. Of course those for which this conversion is lacking will benefit from higher T3 doses but I'd like to see more control than simply substituting a one-size T4 regimen for an equivalent T3 regimen. Also I think the study should be compartmentalized to study separately patient groups with progressively less remaining thyroid activity, right down to groups with none. I shall communicate with Joncklaas putting this point forward in case they haven't thought of it. Otherwise the results overall could be confounded by those with significant residual function not seeing a benefit, whereas the totally bereft may do so.