Magazine article Clinical Psychiatry News

Metadoxine Misses Primary Endpoint in Phase III ADHD Trial

Magazine article Clinical Psychiatry News

Metadoxine Misses Primary Endpoint in Phase III ADHD Trial

Article excerpt

AT THE AACAP ANNUAL MEETING

SAN DIEGO -- Metadoxine extended release missed its primary endpoint in a phase III trial of adults with attention-deficit/hyperactivity disorder, Dr. Lenard A. Adler reported at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

After 6 weeks of treatment, patients' scores on the Conners' Adult ADHD Investigator Rating Scale with adult prompts (CAARS-Inv) had dropped a mean of 12 points from baseline, compared with a 9.9-point decrease for the placebo group (P = .136), said Dr. Adler, a professor of psychiatry at NYU Langone Medical Center in New York.

The "nonsignificant positive trend" could be attributable in part to a "larger placebo effect than previously reported," Dr. Adler said. The only significant result for the primary outcome measure came from a post hoc, modified intention-to-treat analysis that excluded entry criteria violations and patients with measures at least 3 standard deviations outside the mean, he added. Excluding those patients led to a 2.92 least-squares mean difference between the treatment and placebo groups, for a P value of .038, he reported.

Metadoxine is an ion-pair salt of vitamin [B.sub.6] and 2-pyrrolidone-5-carboxylate. Since the 1980s, an immediate-release form of the drug has been available in certain countries for treating alcohol intoxication and alcoholic liver disease. Metadoxine has gamma-aminobutyric acid ([GABA.sub.B]) agonist-like activity and 5-hydroxytryptamine ([5-HT.sub.2B]) antagonist activity, but had little effect on dopamine, norepinephrine, or serotonin in studies of rats.

In a prior phase lib, 6-week, double-blind study of 120 adults with ADHD, patients randomized to metadoxine 1,400 mg once daily had a drop in CAARS-Inv scores compared with the placebo group after 2 weeks of treatment (P < .05), Dr. Adler said. A subgroup analysis showed that the significant effect was confined to the 49 patients with the predominantly inattentive (PI) form of ADHD, he added (mean decrease, 13. …

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