Trial results for Alcobra's new nonstimulant ADHD drug, metadoxine, were released at the American Academy of Child and Adolescent Psychiatry last week in San Diego.
The placebo controlled, randomized study showed that
1) metadoxine, as expected from long experience with use for alcohol related liver damage overseas, is very well tolerated with few side effects compared to placebo. In the 6 week trial, no neurological issues were identified, aside from headaches.
2) metadoxine had a similar impact upon patients with different subtypes of ADHD, and that the effectiveness of metadoxine was not isolated to patients with inattentive ADHD only.
3) metadoxine was not more effective than placebo for changing Connor's scores, but that a statistically nonsignificant trend toward efficacy was present. Also other rating scales for ADHD were significantly affected.
4) The researchers who did the study identified several issues with the study that could have caused the results to show nonsignificant effects, including entry criteria violations and a larger than usual placebo effect.
5) When the data was reanalyzed after excluding people who were outliers and entry criteria violators (post hoc analysis), the trial showed metadoxine's effect to be statistically significant.
Because metadoxine has shown some promise of effectiveness and because it does have very few side effects and is nonaddictive, we can expect that Alcobra will try to continue to pursue further clinical trials to definitively demonstrate effectiveness in the future.
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