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Trial registered on ANZCTR


Registration number
ACTRN12615001059550
Ethics application status
Approved
Date submitted
14/07/2015
Date registered
12/10/2015
Date last updated
17/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Within-Subject Single Dose Trial on the Effects of Bremelanotide on Social Cognition and Behaviour
Scientific title
Do Males Age 16 Years and Older with Autism Spectrum Disorders show an effect of Bremelanotide on Social Cognition and Behaviour?
Secondary ID [1] 287086 0
Nil unknown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 295596 0
Condition category
Condition code
Mental Health 295874 295874 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 subcutaneous injection of 1.75mg of PT-141 or Placebo, followed by a two week wash-out period and then a single dose subcutaneous injection of 1.75mg of PT-141 or placebo. Participants will have exposure to the PT-141 drug within the research premises here in the Brain and Mind Centre, University of Sydney. They are not allowed to go outside the research premises while the drug is active, which will take 45 minutes from drug administration.
Intervention code [1] 292326 0
Treatment: Drugs
Comparator / control treatment
Single dose subcutaneous injection of 1.75mg of placebo. The placebo is composed of 2.5% (w/v) glycerin (United States Pharmacopoeia [USP], mutli-compendial, vegetable-grade) in sterile water for injection, USP, adjusted to pH 5.0 with either hydrochloric acid or sodium hydroxide as necessary.
Control group
Placebo

Outcomes
Primary outcome [1] 295555 0
Correct recognition performance in reading emotions from faces as assess by the eye/faces test
Timepoint [1] 295555 0
45 minutes after each single dose administration
Primary outcome [2] 295556 0
Amount of eye gaze to the eyes of faces using Tobi eye tracker
Timepoint [2] 295556 0
45 minutes after each single dose administration
Secondary outcome [1] 315847 0
Correct response to inclusion and exclusion toward other players using the 'Social Ball-tossing Game' task.
Timepoint [1] 315847 0
45 minutes after each single dose administration
Secondary outcome [2] 317416 0
Degree of Heart Rate Variability as assess by physiological recording of heart-rate
Timepoint [2] 317416 0
45 post drug administration
Secondary outcome [3] 317994 0
Correct performance in reading emotion from scenes using movie still task
Timepoint [3] 317994 0
45 minutes post each single dose administration
Secondary outcome [4] 317995 0
Performance of speed of emotion valence recognition in words using speeded word recognition task comparing social, sexual and control words
Timepoint [4] 317995 0
45 minutes post administration

Eligibility
Key inclusion criteria
Participants must meet DSM-IV-TR criteria for Autistic Disorder, Pervasive Developmental Disorder-Not Otherwise Specified or Asperger’s Disorder.
Minimum age
16 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical participants will be excluded if they meet the following exclusion criteria:

Severe depression with suicidal thought/and or actions, High blood pressure, Severe cardiovascular problems, Kidney disease, Psychosis, Addiction to nicotine and/or illicit substances.

Concomitant medications that exclude participants: use of
phosphodiesterase type 5 inhibitor (e.g., erectile dysfunction) medications.

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 subcutaneous injection. 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
13/10/2015
Actual
17/11/2015
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
60
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9964 0
2050 - Camperdown
Recruitment postcode(s) [2] 9965 0
2046 - Abbotsford
Recruitment postcode(s) [3] 9966 0
2131 - Ashfield
Recruitment postcode(s) [4] 9967 0
2041 - Balmain
Recruitment postcode(s) [5] 9968 0
2137 - North Strathfield
Recruitment postcode(s) [6] 9969 0
2132 - Croydon
Recruitment postcode(s) [7] 9970 0
2042 - Newtown
Recruitment postcode(s) [8] 9971 0
2040 - Leichhardt
Recruitment postcode(s) [9] 9972 0
2045 - Haberfield
Recruitment postcode(s) [10] 9973 0
2204 - Marrickville
Recruitment postcode(s) [11] 9974 0
2130 - Summer Hill
Recruitment postcode(s) [12] 9975 0
2007 - Broadway
Recruitment postcode(s) [13] 9976 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 291648 0
Charities/Societies/Foundations
Name [1] 291648 0
Simons Foundations
Country [1] 291648 0
United States of America
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] 290688 0
None
Name [1] 290688 0
Address [1] 290688 0
Country [1] 290688 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293175 0
University of Sydney
Ethics committee address [1] 293175 0
The University of Sydney, Margaret Telfer Building (K07), University of
Sydney, NSW 2006
Ethics committee country [1] 293175 0
Australia
Date submitted for ethics approval [1] 293175 0
Approval date [1] 293175 0
28/11/2013
Ethics approval number [1] 293175 0
2012/2816

Summary
Brief summary
The aim of this proposal is to conduct the first study of the impact of subcutaneous administration of PT-141 on key mechanisms involved in social communication in adults with
autism. We hypothesize that PT-141 will, in comparison to an identical and matched placebo: increase gaze duration and fixations to key face regions, improve accuracy and the speed of identification of facial emotion recognition, increase heart rate variability, and improve accuracy of response to social cues.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58778 0
A/Prof Adam Guastella
Address 58778 0
Brain and Mind Research Institute, 100 Mallett Street, Camperdown, NSW
2050
Country 58778 0
Australia
Phone 58778 0
+61 2 9351 0539
Fax 58778 0
Email 58778 0
[email protected]
Contact person for public queries
Name 58779 0
Christine Yun Song
Address 58779 0
Brain and Mind Research Institute, 94 Mallett Street, Camperdown, NSW
2050
Country 58779 0
Australia
Phone 58779 0
+61 2 9351 0940
Fax 58779 0
Email 58779 0
[email protected]
Contact person for scientific queries
Name 58780 0
Adam Guastella
Address 58780 0
Brain and Mind Research Institute, 100 Mallett Street, Camperdown, NSW
2050
Country 58780 0
Australia
Phone 58780 0
+61 2 9351 0539
Fax 58780 0
Email 58780 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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