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Trial registered on ANZCTR


Registration number
ACTRN12619000575134
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
12/04/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
12/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Trial of PRAX-114 to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy in Participants with Major Depressive Disorder
Scientific title
A Phase 2 Clinical Trial of PRAX-114 to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy in Participants with Major Depressive Disorder
Secondary ID [1] 297523 0
PRAX-114-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311732 0
Condition category
Condition code
Mental Health 310359 310359 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PRAX-114 60mg orally once daily for 14 days
Intervention code [1] 313762 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319229 0
Safety and tolerability of PRAX-114 will be assessed through an integrated analysis of the following endpoints: patient and clinician-reported adverse events, physical exams, vital signs, clinical laboratory results, electrocardiogram (ECG), Columbia-Suicide Severity Rating Scale (C-SSRS), and Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S)
Timepoint [1] 319229 0
Baseline, Day 2 to Day 8, Day 15, Day 21 and Day 28
Primary outcome [2] 319230 0
Pharmacokinetics will be performed by LC/MS quantification of PRAX-114 levels in plasma. Parameters include plasma concentrations and accumulation ratios.
Timepoint [2] 319230 0
Baseline, Daily Day 2 to Day 7, Day 15
Secondary outcome [1] 367388 0
The efficacy of PRAX-114 as an adjunctive antidepressant to standard of care will be assessed through an integrated analysis of the following endpoints: changes in Hamilton Depression Rating Scale (HAM-D), Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression (CGI), Symptoms of Depression Questionnaire (SDQ), Pittsburgh Sleep Quality Index (PSQI).
Timepoint [1] 367388 0
Baseline, Daily Day 2 to Day 8, Day 15, Day 21 and Day 28

Eligibility
Key inclusion criteria
- Male or females between the ages of 18 and 65 years
- Clinical diagnosis of major depressive disorder (MDD)
- Chronic medications or interventions must be stable for at least 4 weeks prior to Screening and remain stable throughout the clinical trial
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically significant unstable medical or psychiatric condition, other than MDD
- History of treatment resistant depression (failed 3 adequate trials of antidepressant therapy)
- History of a suicide attempt in last 2 years
- History of bipolar disorder
- History of a psychotic episode in last 2 years
- History of alcohol abuse in last 2 years
- History of substance abuse in last 2 years
- History of seizures in last 5 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302083 0
Commercial sector/Industry
Name [1] 302083 0
Praxis Precision Medicines Australia, Pty Ltd
Address [1] 302083 0
Tower Two Collins Square, Level 36
727 Collins Street Docklands Vic 3008
Country [1] 302083 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Praxis Precision Medicines Australia, Pty Ltd
Address
Tower Two Collins Square, Level 36
727 Collins Street Docklands Vic 3008
Country
Australia
Secondary sponsor category [1] 301900 0
None
Name [1] 301900 0
Address [1] 301900 0
Country [1] 301900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302762 0
Bellberry Human Research Ethics Committees
Ethics committee address [1] 302762 0
123 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 302762 0
Australia
Date submitted for ethics approval [1] 302762 0
Approval date [1] 302762 0
14/12/2018
Ethics approval number [1] 302762 0

Summary
Brief summary
This is a clinical trial of PRAX-114 to assess the safety, tolerability, PK, and efficacy in participants with moderate to severe MDD. Each participant will complete 3 study periods: Screening, Treatment Period (14 days) and Safety Follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91310 0
Prof Paul Fitzgerald
Address 91310 0
Epworth Camberwell
888 Toorak Road
Camberwell, 3124, VIC
Country 91310 0
Australia
Phone 91310 0
+61 3 98054827
Fax 91310 0
Email 91310 0
paul.fitzgerald@monash.edu
Contact person for public queries
Name 91311 0
Dr Bernard Ravina
Address 91311 0
Praxis Precision Medicines
One Broadway
Cambridge, MA 02142
Country 91311 0
United States of America
Phone 91311 0
+1 617 300 8500
Fax 91311 0
Email 91311 0
clinicaltrials@praxismedicines.com
Contact person for scientific queries
Name 91312 0
Dr Bernard Ravina
Address 91312 0
Praxis Precision Medicines
One Broadway
Cambridge, MA 02142
Country 91312 0
United States of America
Phone 91312 0
+1 617 300 8500
Fax 91312 0
Email 91312 0
bernard@praxismedicines.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be shared
What supporting documents are/will be available?
No other documents available
Summary results
No Results