Dr. Joseph Jankovic, Professor of Neurology and Director of the Movement Disorders Clinic at Baylor College of Medicine, and his team at Baylor are currently enrolling patients into two studies designed to improve tics and other symptoms associated with Tourette syndrome (TS).
1. Valbenazine (also known as NBI-98854 and Ingrezza), already approved by the Food and Drug Administration (FDA) for the treatment of tardive dyskinesia, a condition caused by exposure to various drugs used for psychiatric and gastrointestinal disorders, may be beneficial in patients with TS. Patients, 6 to 17 years of age, with established diagnosis of TS may be able to participate in this placebo-controlled study.
2. Deutetrabenazine (also known as SD-809 and Austedo), already approved by the FDA for the treatment of Huntington disease and tardive dyskinesia, is another drug studied at Baylor. TS children, 6 to16 years old, with troublesome tics may be eligible to participate in this double-blind, placebo-controlled, trial.
Once patients are enrolled in one of these clinical trials there is no cost to them for the drugs, visits or laboratory tests used to monitor the drugs.
"Double-blind, placebo controlled" trial simply means that some patients are randomly selected to receive the active (real) drug and others receive an inactive (placebo) drug. Neither the patient nor the physician (investigator) will know to which group the patient was assigned (they are both "blind") until the study is completed. The purpose for this scientific method is to prevent patients or their physicians to be biased about the effects of the drug (good or bad). Once this phase of the study is completed patients can enroll in an "open-label" phase during which each receives the active drug.
All drugs currently on the market must undergo this type of a trial to be approved by the FDA. In Europe, instead of using a placebo, the drug companies must select and appropriate a comparator (a drug that already has been approved for the studied condition).
Parents of children who are interested in participating should call 713-798-2273 to make an appointment for initial evaluation or contact Christine Hunter, RN (713-798-3951) or Ami Patel (713-798-6902) for further information.
The Tourette Association of America - Texas Chapter strongly supports research efforts to alleviate the symptoms of Tourette's and to ultimately find a cure.
There is no cost for medication, doctor visits or lab tests with these two studies.
Without such drug trials, we would not have the medications available so necessary for treatment. However, in these studies your child may or may not receive the medication. Those that do not (i.e., receive the placebo) will be on no medication to relieve the troublesome symptoms. Neither the physician nor the patient knows which child receives medication (double-blind study).