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Clinical Trials/ACTRN12614000747628
ACTRN12614000747628
Recruiting
Phase 2

Do Males age 16 Years and Older with Autism Spectrum Disorders on a single dose course of Phenytoin (compared to a placebo) show an effect on Social Cognition and Behaviour?

niversity of Sydney0 sites20 target enrollmentJuly 14, 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
niversity of Sydney
Enrollment
20
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 14, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Meet DSM\-IV\-TR criteria for Autistic Disorder, Pervasive Developmental Disorder\-Not Otherwise Specified or Asperger’s Disorder

Exclusion Criteria

  • Severe depression, with suicidal thoughts and/or actions; Severe cardiovascular problems; Kidney or Liver problems; Allergies to barbiturates or any other anticonvulsant medicine; Allergies to foods, preservatives or dyes that may be contained in the syrup; Psychosis; Smoke more than 15 cigarettes a day; Phenytoin hypersensitivity; Pregnancy or lactation; High blood sugar levels
  • Concomitant medications that exclude participants: lcuronium, antineoplastic agents, amiodarone, amphotericin B, azapropazone, azoles, capecitabine \[or its metabolite fluorouracil (5FU)], carbamazepine, ciprofloxacin, chloramphenicol, chlordiazepoxide, chlorpropamide, cimetidine, clopidrogel, clozapine, corticosteroids, coumarin anticoagulants, cyclosporine, diazepam, diazoxide, dicumarol, digitoxin, diltiazem, disulfiram, doxycycline, erythromycin, felbamate, fluconazole, fluorouracil, fluoxetine, folic acid, frusemide, fluvoxamine, glibenclamide, H2\-antagonists, halothane, isoniazid, itraconazole, ketoconazole, lamotrigine, methadone, methylphenidate, miconazole, nelfinavir, nicardipine, nimodipine, nifedipine, oestrogens, omeprazole, pancuronium, paroxetine, phenobarbitone, phenothiazines, phenylbutazone, praziquantel, quinidine, reserpine, rifampicin, salicylates, sertraline, sodium valproate, succinimides (ethosuximide, methsuximide, phensuximide), sucralfate, sulfonamides, teniposide, tetracycline, ticlopidine, theophylline, tolbutamide, trazodone, valproic acid, verapamil, vecuronium, vigabatrin, viloxazine; Hypericum perforatum (St John's wort); Antacid preparations containing calcium; Vitamin D

Outcomes

Primary Outcomes

Not specified

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