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Metoclopramide pediatric dose im. D. The primary goal of treatment for patients who suffer from childhood seizures and comorbid ADHD would therefore be to develop a regimen that has acceptable rates of adverse events and tolerable dosing that reduces the frequency of seizures. A second primary goal of treatment would be to develop agents capable of reducing the severity and duration of seizures. Dorsal ventral hippocampal neurogenesis is one possibility that has received intensive study in preclinical studies, whereas other mechanisms are considered as well. We hypothesized that a D-desmethyl phenylethylamine, such as S-(+)-desmethylphenylethylamine, a D-amino phenethylamine, or D-diaminobenzene derivative such as phenylethylamine, would increase the density of astroglial cells and possibly neuronal proliferation, that this neurotrophic effect would be dose-dependent. To examine these suggestions, we conducted a large, randomized, double-blind, placebo-controlled trial to test the effects of novel D-phenylethylamine, S-(+)-desmethylphenylethylamine, on epileptic-type seizures in patients with refractory childhood-onset temporal lobe epilepsy. METHODS In this trial, we randomized patients with refractory childhood-onset temporal lobe epilepsy and a pediatric D-phenylisopropylamine dose of 1 mg/kg b.i.d. to receive either S-(+)-desmethylphenylethylamine or standard of care, which also included standard therapy. All patients received a second dose of 10 mg/kg b.i.d. per day of phenylethylamine or placebo for 3 months. All patients were monitored for safety, efficacy, and adverse effects after 2 weeks of treatment. We conducted an extension analysis of the trial and found that S-(+)-desmethylphenylethylamine is generally well tolerated, with no evidence of serious toxicity or life-threatening events associated with its administration. RESULTS Forty-one patients participated in the clinical trial and were randomized to either S-(+)-desmethylphenylethylamine or standard of care, which also included standard therapy. Seventy-eight patients were treated with S-(+)-desmethylphenylethylamine (23 1 mg/kg b.i.d., 24 with 10 per day, 2 and 3 mg/kg b.i.d. per day, and 11 with placebo). The incidence of adverse effects associated with S-(+)-desmethylphenylethylamine was low, only one case of hypotension and no cases vomiting or diarrhea. Most of the patients developed a positive response to the drug and showed significant improvement after 2 weeks of treatment. the 26 patients on phenylethylamine alone, 13 (77%) showed significant seizure reduction in 1 month and 12 patients (77%) in 2 weeks. Seven patients (38%) showed a dose-related reduction in the cumulative number of seizures in 1 month and two of these patients achieved complete seizure control. Eight patients (63%) showed a clinical outcome in the 2 weeks between time of randomized drug initiation and 3 months in which some seizures were reduced compared with the initial seizure level, and 17 (82%) showed a reduction in the cumulative number of seizures in 3 months. Only three patients (15%) in the S-(+)-desmethylphenylethylamine group and 17 patients (85%) in the standard of care group (p = 0.03 and p 0.07, respectively) required medication discontinuation and 1 patient, who underwent major neurosurgery, was withdrawn from the study because of adverse effects. 24 patients receiving standard of care alone, 11 showed a significant improvement in the cumulative number of seizures in 1 month, best drugstore eye cream real simple whereas 8 patients experienced an improvement in the cumulative number of seizures in 3 Adderal 30 $125.00 $4.17 $112.50 months (p = 0.02). Among the 17 patients treated with placebo, 11 (75%) showed an improvement in seizures 1 month and 6 patients (42%) in 3 months. One patient, who required a hip replacement after surgery, was withdrawn from the study. Of 19 patients receiving phenylethylamine with standard of care, all experienced either no improvement (one patient), or an that was not statistically significant after 5 weeks and then became statistically significant after 8 weeks (one patient) and after 12 weeks (two patients), whereas the placebo group improved for 6 weeks after randomization (nine patients). Among the 12 patients who received drug in combination with phenylethylamine (S-(+)- desmethylphenylethylamine), 4 (33%) exhibited a decrease in cumulative number of seizures over 2 months, whereas 6 (45%) showed no improvement or an that was not statistically significant after 2 weeks of treatment and were therefore withdrawn from the study.
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