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Trial registered on ANZCTR


Registration number
ACTRN12614000747628
Ethics application status
Approved
Date submitted
27/06/2014
Date registered
14/07/2014
Date last updated
19/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Within-Subject Randomized Controlled Trial on the Effects of Phenytoin on Social Cognition and Behaviour in Males aged 16 Years and Older with Autism Spectrum Disorders
Scientific title
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?
Secondary ID [1] 284797 0
2013771
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 292173 0
Condition category
Condition code
Mental Health 292510 292510 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive both treatments in a random order. Participants are randomised to receive either a single dose oral administration of 4mg syrup of Phenytoin or Placebo, followed by a two week wash-out period and then a single dose administration of 4mg syrup of Phenytoin or Placebo.
Intervention code [1] 289586 0
Treatment: Drugs
Comparator / control treatment
Single dose oral administration of 4mg syrup of Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 292400 0
Improved social cognition as assessed by the Eye-Gaze Movie Scene Task - duration (total milliseconds spent fixating on the face region) and fixation count (number of times a participant fixated toward a face region).
Timepoint [1] 292400 0
45 minutes after each single dose administration
Primary outcome [2] 292401 0
Improved accuracy and speed of identification of the correct emotion from faces as assessed by the Reading the Mind in the Eyes Test (RMET) and the Speeded Face Expression Recognition Task.
Timepoint [2] 292401 0
45 minutes after each single dose administration
Primary outcome [3] 292403 0
Increased Heart Rate Variability assessed by the Polar RS800CX heart rate monitoring system
Timepoint [3] 292403 0
45 minutes after each single dose administration
Secondary outcome [1] 308873 0
Improved capacity to correctly respond to social cues as assessed by the Social Ball-tossing Game.
Timepoint [1] 308873 0
45 minutes after each single dose administration

Eligibility
Key inclusion criteria
Meet DSM-IV-TR criteria for Autistic Disorder, Pervasive Developmental Disorder-Not Otherwise Specified or Asperger’s Disorder
Minimum age
16 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are assigned to sequential treatment packs labelled with a unique study number. Neither participants nor research staff will be aware of the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation follows a computer-generated randomisation schedule with balanced variable blocks, prepared by the pharmacist. Each re-packed treatment contains one active and one identical and matched placebo syrup. The pharmacist will hold the randomisation code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/07/2014
Actual
23/04/2015
Date of last participant enrolment
Anticipated
30/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2678 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 8311 0
2050 - Camperdown
Recruitment postcode(s) [2] 8346 0
2046 - Abbotsford
Recruitment postcode(s) [3] 8347 0
2131 - Ashfield
Recruitment postcode(s) [4] 8348 0
2041 - Balmain
Recruitment postcode(s) [5] 8349 0
2137 - North Strathfield
Recruitment postcode(s) [6] 8350 0
2132 - Croydon
Recruitment postcode(s) [7] 8351 0
2042 - Newtown
Recruitment postcode(s) [8] 8352 0
2040 - Leichhardt
Recruitment postcode(s) [9] 8353 0
2045 - Haberfield
Recruitment postcode(s) [10] 8354 0
2204 - Marrickville
Recruitment postcode(s) [11] 8355 0
2130 - Summer Hill
Recruitment postcode(s) [12] 8356 0
2007 - Broadway
Recruitment postcode(s) [13] 8357 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 289494 0
Commercial sector/Industry
Name [1] 289494 0
Autres PTYLD
Country [1] 289494 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
College Street, University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 288177 0
None
Name [1] 288177 0
Address [1] 288177 0
Country [1] 288177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291190 0
University of Sydney
Ethics committee address [1] 291190 0
Ethics committee country [1] 291190 0
Australia
Date submitted for ethics approval [1] 291190 0
Approval date [1] 291190 0
12/11/2013
Ethics approval number [1] 291190 0
2013/771

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49186 0
A/Prof Adam Guastella
Address 49186 0
Brain and Mind Research Institute 100 Mallett Street Camperdown NSW 2050
Country 49186 0
Australia
Phone 49186 0
61293510539
Fax 49186 0
Email 49186 0
[email protected]
Contact person for public queries
Name 49187 0
Christine Song
Address 49187 0
Brain and Mind Research Institute 94 Mallett Street Camperdown NSW 2050
Country 49187 0
Australia
Phone 49187 0
61 2 9351 0940
Fax 49187 0
Email 49187 0
[email protected]
Contact person for scientific queries
Name 49188 0
Adam Guastella
Address 49188 0
Brain and Mind Research Institute 100 Mallett Street Camperdown NSW 2050
Country 49188 0
Australia
Phone 49188 0
61293510539
Fax 49188 0
Email 49188 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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