The UC Irvine Center for the Medical Treatment of Stuttering recently conducted a study on Pagaclone, the first medication designed specifically to treat stuttering.
Although Pagaclone has yet to be approved for sale in the United States, the medicine has passed Phase II of the Food and Drug Administration’s three-phase testing cycle. According to FDA regulations, these clinical trials are required before medications can be put on the retail market. Dr. Gerald A. Maguire, director of the Center for the Medical Treatment of Stuttering, served as the chief investigator on this study.
Although a number of medications already exist to treat stuttering, such as Olanzapine and Risperidone, the principle uses of these medications are to treat schizophrenia, bipolar disorder and dementia. As Maguire mentioned, Pagaclone is not only designed to treat stuttering, specifically, but does so in a different way than these already existing medications.
‘It is a different mechanism of action. Olanzapine and Risperidone worked primarily on dopamine blocking, by blocking that chemical in the brain to prevent stuttering. The way Pagaclone works is by increasing a chemical called GABA, [which] may then decrease the dopamine transmission in the brain,’ Maguire said.
Although there are optimistic signs that Pagaclone will be approved for sale in the United States, the final decision on whether the product will be available to the public is still up in the air. However, if the track record of stuttering research at UCI is any indication, Pagaclone may be on the market much sooner than later as Maguire has helmed several successful projects in the past.
One such experiment was conducted by the UCI Stuttering Research Group, which worked on a study examining how different areas of the brain affect stuttering.
Dr. Joseph Wu, who worked as a co-investigator on these series of trials, explained the hypothesis of the project in scientific terms.
‘Our initial hypothesis was that there would be differences in brain regions hypothesized to play roles in stuttering such as language cortical areas and their interconnected subcortical pathways, which were indeed confirmed,’ Wu said.
In simpler terms, this means that the group examined different parts of the human brain in order to show their effects on stuttering through the cortex and cortex-related areas. The cortex is the outer layer of the cerebrum in the human brain, which is densely packed with nerve endings. The cerebrum itself is a large region of the brain, which controls such functions as language, communication, movement and memory.
However, according to Wu, the findings of this project opened up a plethora of follow-up questions, such as calling into question the role that chemicals found in the brain play in neurological systems capable of affecting stuttering.
Likewise, if Pagaclone is put on the market, not only will a medication designed specifically to treat stuttering be available, but the floodgates for similar medications may open up.
‘[Pagaclone’s FDA approval] would potentially be a gateway for other medications. Also it would be an acknowledgement that stuttering is a disorder that could be treated by medications effectively,’ Maguire said.
When the Phase III trial for Pagaclone goes into effect, the clinical trial will follow FDA regulations and be tested on 1,000 to 3,000 people