My name is Joohi Jimenez-Shahed, I’m a movement disorders neurologist at Baylor College of Medicine in Houston and my role in this study was actually to serve as one of the central raters for the video assessments of tardive dyskinesia in the study of deutetrabenazine. Deutetrabenazine is a medication that’s being investigated for treatment of tardive dyskinesia and in the secondary analyses for this study, we were investigating whether or not there was a difference in response or safety in patients who were treated with concomitant dopamine blockade – dopamine blocking medications or antipsychotics. So the population of patients that have tardive dyskinesia are patients with psychiatric conditions that have had exposure to neuroleptics and treatment for those patients has been limited. We haven’t had until recently some medications that could be directed for that so we had to consider taking patients off their neuroleptics, which of course could worsen their underlying condition; it could cause worsening of the involuntary movements or worsening of the psychiatric problems, so it’s of particular relevance to investigate whether or not a treatment for tardive dyskinesia that also blocks dopamine could be used in combination with their concomitant neuroleptic medications, and that was really the primary focus of this sub-analysis.
So patients in this study were randomized to treatment with either 12, 24, or 36 milligrams per day [of deutetrabenazine]. As I mentioned they were allowed to stay on their baseline neuroleptic medications. The primary endpoint in the trial was the change in the AIM score which is an assessment scale for the involuntary movements and the secondary endpoints were looking at side effects and a number of different analyses there. So the baseline characteristics by treatment groups, so these are organized by the dosing, and you can see that a significant proportion of patients on the order of 60 to 70% of individuals who are participating in the study were continuing on their baseline neuroleptic use and the primary psychiatric reasons for them to be taking these medications were either psychotic disorders or mood disorders, and so that was the population that we had.
Based on the analyses, the patients who were treated with 24 and 36 mg per day had a significant reduction in the AIM score and it really did not differ according to whether or not they were using concomitant antipsychotic or neuroleptic medication. The other major findings from this sub-analysis was looking at groups who were taking a neuroleptic vs those individuals who were not taking a neuroleptic in this study, there was really not a difference in the side effect profile, so we know that this drug can be used safely in patients who are continuing medications for underlying psychiatric disorder.