Thanks Deano, as the CTR site isnt always up to date, i suggest you , and other, look back at the 5th of April announcment. outline in detail the trial, the outcomes to date,
Study Outcomes to date (at 5 April)
Demonstrated safety and tolerability across the dosing regimen.
No Serious Adverse Events (SAEs) reported.
Patients are showing positive trends and improvements compared to their baseline assessments
measured at the commencement of the trial.
Improvements were observed with trial patients in key behavioural indicators related to irritability,
social interaction, mood and communication.
The improvements were unique to each trial participant given the complexities of how ASD affects
children.
Assessments of efficacy:
Efficacy will be monitored and measured through parent/carer and physician questionnaires.
The secondary outcomes measures listed below will be used to assess potential improvements of:
Irritability
Hyperactivity
Mood
Self-stimulation
Sleep disorders
Seizures
Behavioural Crises
Social Interaction
Communication
there is then detail on how these secondary endpoint were assessed (i.e. the relevant measurment scale that is used in the industry)... It is worth a read..
I agree completely on understanding why the results have taken so long, so many data points, and they did note that each trial participant had different results. So that take a lot of time to work through and comprehend.
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Thanks Deano, as the CTR site isnt always up to date, i suggest...
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