dizziness drug trial

Clinical Trial For Motion Sickness Drug Now Over 50% Enrolled

WASHINGTON, DCGT Biopharma Inc., a clinical stage biotech company, announced the Proof-of-Concept clinical trial of its novel drug treatment for motion sickness, GTP-011, is now more than 50% enrolled. According to the announcement, the trial is a single-blind, placebo-controlled, cross-over study. The study’s primary objective will be to demonstrate the efficacy of transdermal GTP-011 on treating the symptoms of motion sickness.

The cause of motion sickness is still not fully understood, but is believed to involve a sensory conflict between the visual and the inner ear (vestibular system). According to the Vestibular Disorders Association (VEDA) more than 35% of US adults 40 years and older, or approximately 69 million people, experience vestibular dysfunction at some point in their lives, some of which may go on to develop a chronic vestibular disorder.
 

Motion Sickness: Symptoms and Treatment

 

Common symptoms of motion sickness, and certain vestibular disorders, include: vomiting preceded by nausea, malaise, drowsiness, headache and sweating, among others.

 

Currently, one of the most common first line treatments would include things like the scopolamine patch to prevent motion sickness (Gil et al., 2012; Brainard and Gresham, 2014). However, side effects can be of particular concern and include sedation (Spinks et al., 2004), reduced memory for new information, impaired attention, and lowered feelings of alertness (Parrott, 1989). Mental confusion or delirium can occur after application of scopolamine patch (Seo et al., 2009). Elderly people as well as people with undetected incipient dementia or mild cognitive impairment, or MCI, may be particularly prone to develop mental confusion after applying the scopolamine patch (Seo et al., 2009).

 

According to the company, GTP-011 is a 72-hour, transdermal formulation that contains a muscarinic receptor antagonist. Unlike the most currently used treatment options, GTP-011’s active ingredient has been reported not to affect memory and cognition, and is also reported to have a low incidence of sedation (Kay et al., 2012). For this reason, GT Biopharma believes GTP-011 could be particularly useful for elderly patients .

Beyond motion sickness, the company believes GTP-011 may also have utility in treating other disorders of the vestibular system and will be evaluating those possibilities, assuming positive data is received from the ongoing Proof-of-Concept clinical trial. 

The clinical trial is sponsored by the Cognitive Research Corporation.

Source: GT Biopharma

*image courtesy flckr