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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04969510


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04969510
Ethics application status
Date submitted
8/07/2021
Date registered
20/07/2021
Date last updated
19/08/2022

Titles & IDs
Public title
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
Scientific title
A Phase 2 Double-blind, Placebo-Controlled, Dose-Ranging Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Adjunctive and Monotherapy Treatment of Participants With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Secondary ID [1] 0 0
PRAX-114-214
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 10 mg PRAX-114
Treatment: Drugs - 20 mg PRAX-114
Treatment: Drugs - 40 mg PRAX-114
Treatment: Drugs - 60 mg PRAX-114
Treatment: Drugs - Placebo

Experimental: PRAX-114 (10 mg) - 10 mg PRAX-114 once daily

Experimental: PRAX-114 (20 mg) - 20 mg PRAX-114 once daily

Experimental: PRAX-114 (40 mg) - 40 mg PRAX-114 once daily

Experimental: PRAX-114 (60 mg) - 60 mg PRAX-114 once daily

Placebo comparator: Placebo - Placebo once daily


Treatment: Drugs: 10 mg PRAX-114
Once daily oral treatment

Treatment: Drugs: 20 mg PRAX-114
Once daily oral treatment

Treatment: Drugs: 40 mg PRAX-114
Once daily oral treatment

Treatment: Drugs: 60 mg PRAX-114
Once daily oral treatment

Treatment: Drugs: Placebo
Once daily oral treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in HAM-D17 total score at Day 15
Timepoint [1] 0 0
15 days
Secondary outcome [1] 0 0
Change from baseline in HAM-D17 total score at Day 29
Timepoint [1] 0 0
29 days
Secondary outcome [2] 0 0
Change from baseline in HAM-D17 total score at all other time points
Timepoint [2] 0 0
4 days, 8 days, 22 days, 36 days, and 43 days
Secondary outcome [3] 0 0
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points
Timepoint [3] 0 0
4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Secondary outcome [4] 0 0
Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points
Timepoint [4] 0 0
4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Secondary outcome [5] 0 0
HAM-D17 response (reduction from baseline score of =50%) at Day 15, Day 29, and all other time points
Timepoint [5] 0 0
4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Secondary outcome [6] 0 0
HAM-D17 remission (total score of =7) at Day 15, Day 29, and all other time points
Timepoint [6] 0 0
4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Secondary outcome [7] 0 0
Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points
Timepoint [7] 0 0
4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Secondary outcome [8] 0 0
Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points
Timepoint [8] 0 0
4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Secondary outcome [9] 0 0
Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points
Timepoint [9] 0 0
4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days

Eligibility
Key inclusion criteria
1. Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months.
2. HAM-D17 total score of =20 at Screening and Baseline
3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
4. Adjunctive treatment participants only: Inadequate response to treatment in the current MDD episode, defined as <50% reduction in depression severity in response to at least 1 and no more than 2 antidepressant trials at an adequate dose and duration in the current MDE as specified in the ATRQ.
5. Adjunctive treatment participants only: Stable regimen of antidepressant treatment for at least 8 weeks prior to Baseline, with no clinically meaningful change (defined as no increase in dose and no decrease in dose =25% for tolerability) during that period.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lifetime history of seizures, including febrile seizures.
2. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
3. Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years.
4. Any current psychiatric disorder (other than MDD).
5. Lifetime history of treatment resistant depression.
6. Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening.
7. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

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
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2022
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Praxis Research Site - Noble Park
Recruitment postcode(s) [1] 0 0
3174 - Noble Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Praxis Precision Medicines
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD. The study will enroll participants on adjunctive treatment who had an inadequate response to their current antidepressant treatment and participants not currently being treated with pharmacotherapy for MDD. A sub-study to investigate the pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants with MDD will be conducted in a subset of participants at selected research sites with serial PK sampling capabilities.
Trial website
https://clinicaltrials.gov/study/NCT04969510
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Executive Director Clinical Development
Address 0 0
Praxis Precision Mediciines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04969510

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
QLD,VIC
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Praxis Precision Medicines Australia, Pty Ltd
Primary sponsor address
Tower Two Collins Square, Level 36
727 Collins St, Docklands, Vic, 3008
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
 
Public notes

Contacts
Principal investigator
Title 313 0
Name 313 0
Address 313 0
Country 313 0
Phone 313 0
Fax 313 0
Email 313 0
Contact person for public queries
Title 314 0
Name 314 0
Address 314 0
Country 314 0
Phone 314 0
Fax 314 0
Email 314 0
Contact person for scientific queries
Title 315 0
Name 315 0
Address 315 0
Country 315 0
Phone 315 0
Fax 315 0
Email 315 0