Trial Review

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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
3/03/2022
Date data sharing statement initially provided
12/04/2019
Date results provided
3/03/2022
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
Part A (inpatient and outpatient) and Part B (outpatient only): PRAX-114 60mg orally once daily for 14 days
Part C: PRAX-114 60mg orally once daily for 27 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
Part A: Baseline, Day 2 to Day 8, Day 15, Day 21 and Day 28
Part B: Baseline, Day 4, Day 8, Day 15, Day 21 and Day 28
Part C: Baseline, Day 8, Day 15, Day 21, Day 28, Day 35 and Day 42
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
Part A: Baseline, Daily Day 2 to Day 7, Day 15
Part B: Baseline, Day 4, Day 8, Day 15
Part C: Baseline, Day 8, Day 15, Day 21, Day 28, Day 42
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
Part A: Baseline, Day 2 to Day 8, Day 15, Day 21, and Day 28,
Part B: Baseline, Day 4, Day 8, Day 15, Day 21, and Day 28
Part C: Baseline, Day 8, Day 15, Day 21, Day 28, Day 35, and Day 42

Eligibility
Key inclusion criteria
For Part A:
- 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
- Willing to comply with the protocol (including inpatient stay)

For Part B:
- Females 40 years of age or older with irregular menses
- Historical self-report of vasomotor symptoms
- 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
- Willing to comply with the protocol

For Part C:
- 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
- Willing to comply with the protocol
Minimum age
18 Years
Maximum age
65 Years
Sex
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
Completed
Date of first participant enrolment
Anticipated
15/04/2019
Actual
21/05/2019
Date of last participant enrolment
Anticipated
Actual
29/04/2021
Date of last data collection
Anticipated
Actual
29/04/2021
Sample size
Target
60
Accrual to date
Final
52
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
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
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
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
[email protected]
Contact person for public queries
Name 91311 0
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 8460
Fax 91311 0
Email 91311 0
[email protected]
Contact person for scientific queries
Name 91312 0
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 8460
Fax 91312 0
Email 91312 0
[email protected]

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 Supporting Document Provided



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.