Clinical Trial for Tourette Syndrome Does Not Meet Endpoints

Teva Pharmaceuticals recently finished two clinical trials of their Tourette syndrome treatment, deutetrabenazine. These two studies, titled ARTISTS 1 and ARTISTS 2, did not meet their primary endpoints, as they did not reduce motor and phonic tics to the expected level. Researchers are disappointed by the results of this study, especially as deutetrabenazine was intended for the treatment of pediatric patients who lack medications for Tourette syndrome.

About Tourette Syndrome

Tourette syndrome is a nervous system disorder that is characterized by tics, which are involuntary movements or sounds. About 100,000 to 300,000 people are affected by this disorder in the United States.

Symptoms of Tourette syndrome vary greatly between individuals, as everybody experiences different tics. These tics can be brought on by a variety of triggers, such as stress, fatigue, illness, or excitement. Symptoms of this syndrome include:

  • Jerking of the arms and head
  • Repeated eye blinking
  • Nose twitching
  • Bending or twisting
  • Shrugging
  • Obscene gestures or words
  • Grunting or barking
  • Coughing and clearing the throat
  • Repeating words
  • Attention deficit disorder
  • Obsessive compulsive disorder

The exact cause of this condition is unknown, although it is suspected to be a combination of inherited and environmental factors. Others believe that chemical imbalances within the brain result in Tourette syndrome.

No cure exists for Tourette syndrome. Treatment consists of medications that block dopamine, Botox injections, seizure medications, anti-depressants, and behavioral therapy. If one is affected by an extremely severe case, doctors may use a device that sends electrical impulses to the brain.

About Deutetrabenazine

Deutetrabenazine is an FDA approved treatment for chorea that those with Huntington’s disease experience, as well as tardive dyskinesia. It was approved in 2017. It is a vesicular monoamine transporter 2 inhibitor. It is currently being investigated for the treatment of Tourette syndrome, so the safety profile and effects have not yet been fully investigated and established.

ARTISTS 1 and 2

Both of the ARTISTS studies were double-blind, placebo-controlled, multicenter, and randomized. ARTISTS 1 recently completed Phase 2/3, which was intended to evaluate safety, tolerability, and efficacy. 119 patients, aged six to 16 with moderate to severe symptoms, were dosed over a 12 week period. Phase 3 of ARTISTS 2 was recently completed and included 158 pediatric participants. This phase lasted for eight weeks and evaluated safety, efficacy, and tolerability. Both of these trials were measured on Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS).

Both of these studies failed to meet their primary endpoints, and they also brought adverse effects. The most common were headaches, somnolence, and fatigue. A positive from these studies was that no new safety issues were identified. Researchers hope that they can use the information learned from these studies to improve future trials and the medication itself.

Find the source article here.

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