Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000228785
Ethics application status
Approved
Date submitted
4/02/2022
Date registered
9/02/2022
Date last updated
20/04/2022
Date data sharing statement initially provided
9/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Muscarinic modulation of human electroencephalography (EEG) activity using scopolamine
Scientific title
Measuring the effects of intravenous scopolamine on the human EEG in healthy volunteers
Secondary ID [1] 306332 0
Nil
Universal Trial Number (UTN)
Trial acronym
HIGGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depression 325148 0
Condition category
Condition code
Mental Health 322551 322551 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: A single intravenous infusion of 4 µg/kg scopolamine hydrobromide given over 15 minutes under clinical observation
Arm 2: A single intravenous infusion of 5 µg/kg scopolamine hydrobromide given over 15 minutes under clinical observation
Arm 3: A single intravenous infusion of 6 µg/kg scopolamine hydrobromide given over 15 minutes under clinical observation
Intervention code [1] 322777 0
Treatment: Drugs
Comparator / control treatment
A single intravenous infusion of 4 µg/kg glycopyrronium bromide given over 15 minutes under clinical observation
Control group
Active

Outcomes
Primary outcome [1] 330342 0
Power spectral density of the eyes-open EEG
Timepoint [1] 330342 0
Collected at 5, 10, 15, 20, 30, 60, 120 and 240 minutes relative to the start of the infusion
Secondary outcome [1] 405882 0
Pharmacokinetic parameters of scopolamine in blood including Cmax, AUC, T1/2, Clearance and Volume of distribution
Timepoint [1] 405882 0
Blood samples collected at 5, 10, 15, 20, 30, 60, 120 and 240 minutes relative to the start of the infusion

Eligibility
Key inclusion criteria
• Male or female, aged 18 years or above and less than 60.
• In the Investigators’ opinion, is able and willing to comply with all trial requirements.
• Participant is willing and able to give informed consent for participation in the trial.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• Regular use of any medication deemed to be contraindicating as judged by the attending study clinicians.
• Contraindication to the use of scopolamine or glycopyrrolate according to manufacturer guideline
• Significant renal or hepatic impairment.
• Participants with glaucoma
• Cardiovascular conditions including abnormal heart rate and blood pressure checked at screening.
• History of psychiatric illness.
• Any unstable medical or neurologic condition.
• Problematic substance dependence in previous 3 months
• Inability to speak or read English.
• Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
14/06/2021
Date of last participant enrolment
Anticipated
14/06/2022
Actual
10/12/2021
Date of last data collection
Anticipated
14/06/2022
Actual
17/12/2021
Sample size
Target
40
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 24539 0
New Zealand
State/province [1] 24539 0

Funding & Sponsors
Funding source category [1] 310685 0
Government body
Name [1] 310685 0
Health Research Council of New Zealand
Country [1] 310685 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 311905 0
None
Name [1] 311905 0
Address [1] 311905 0
Country [1] 311905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310270 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 310270 0
Ethics committee country [1] 310270 0
New Zealand
Date submitted for ethics approval [1] 310270 0
Approval date [1] 310270 0
28/05/2021
Ethics approval number [1] 310270 0

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

Contacts
Principal investigator
Name 117074 0
A/Prof Suresh Muthukumaraswamy
Address 117074 0
The University of Auckland
Building 505
85 Park Road
Grafton 1023
Auckland
Country 117074 0
New Zealand
Phone 117074 0
+64 09 3737599 82787
Fax 117074 0
Email 117074 0
[email protected]
Contact person for public queries
Name 117075 0
Suresh Muthukumaraswamy
Address 117075 0
The University of Auckland
Building 505
85 Park Road
Grafton 1023
Auckland
Country 117075 0
New Zealand
Phone 117075 0
+64 09 3737599 82787
Fax 117075 0
Email 117075 0
[email protected]
Contact person for scientific queries
Name 117076 0
Suresh Muthukumaraswamy
Address 117076 0
The University of Auckland
Building 505
85 Park Road
Grafton 1023
Auckland
Country 117076 0
New Zealand
Phone 117076 0
+64 09 3737599 82787
Fax 117076 0
Email 117076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14941Informed consent form  [email protected]
14942Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.