Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000555459
Ethics application status
Approved
Date submitted
14/05/2025
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy, Safety, and Tolerability of BRP-185 (Bupropion immediate-release (IR) and sustained-release (SR)) in Adults with Idiopathic Hypersomnia
Scientific title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BRP-185 (Bupropion IR/SR) in Adults with Idiopathic Hypersomnia
Secondary ID [1] 314450 0
BRP-185-IH-2024-001
Secondary ID [2] 314516 0
CT-2025-CTN-01901-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Hypersomnia 337488 0
Condition category
Condition code
Neurological 333853 333853 0 0
Other neurological disorders
Mental Health 334002 334002 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicentre trial evaluating two dose levels of BRP-185 against placebo in adult patients diagnosed with idiopathic hypersomnia. BRP-185 is a combination of Bupropion immediate-release (IR) and sustained-release (SR) formulations. There are 2 treatment groups:
1. High-dose BRP-185 group (225 mg - 75 mg Bupropion IR + 150 mg Bupropion SR) – oral capsule once daily in the morning
2. Low-dose BRP-185 group (150 mg - 75 mg Bupropion IR + 75 mg Bupropion SR) – oral capsule once daily in the morning
The study is structured into three distinct phases: the screening phase, the treatment phase, and the follow-up phase, each designed to ensure accurate diagnosis, appropriate treatment administration, and comprehensive safety monitoring.
The screening phase lasts up to 28 days and serves to confirm eligibility based on the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Idiopathic Hypersomnia (IH). Participants undergo comprehensive medical evaluations, including a detailed clinical history, physical examination, and objective sleep assessments. Baseline sleep data is obtained using actigraphy and sleep logs, with polysomnography (PSG) performed if necessary to rule out other sleep disorders. If participants have been using wake-promoting agents before enrollment, they are required to undergo a washout period to eliminate residual pharmacological effects that may confound baseline assessments. Once eligibility is confirmed, participants proceed to randomization.
The treatment phase spans 12 weeks, during which participants receive once-daily morning doses of their assigned treatment. Throughout this period, participants attend scheduled clinic visits at Weeks 2, 4, 8, and 12, during which assessments such as the Epworth Sleepiness Scale (ESS), sleep inertia severity, and functional tests are performed. Cognitive neuropsychological tests, and sleep patterns are assessed through actigraphy and sleep diaries. Safety monitoring is conducted at all study visits, with adverse event tracking, laboratory tests, electrocardiograms (ECG), and vital sign assessments. Participants also complete patient-reported outcome measures, including the Patient Global Impression of Change (PGIC) scale.
The follow-up phase lasts for two weeks following the completion of the treatment phase. Participants return for a final clinical assessment, during which vital signs, laboratory parameters, and ECG findings are reviewed.
Adherence strategies to assess compliance include study drug compliance monitoring via the study app, return of unused Investigational Product (IP) during clinic visits for reconciliation.
Intervention code [1] 331071 0
Treatment: Drugs
Comparator / control treatment
The placebo product is an oral capsule containing Microcrystalline cellulose. The placebo has the same appearance and capsule size as the BRP-185 finished product.
Control group
Placebo

Outcomes
Primary outcome [1] 341473 0
To evaluate the efficacy of BRP-185 in changing excessive daytime sleepiness (EDS) in adults with idiopathic hypersomnia
Timepoint [1] 341473 0
Week 12 from Baseline
Secondary outcome [1] 447675 0
Assess the effect of BRP-185 on sleep inertia severity and duration (composite outcome)
Timepoint [1] 447675 0
Baseline and Week 12 post-commencement of intervention
Secondary outcome [2] 447676 0
Evaluate change in total sleep time (TST) and sleep consolidation (composite outcome)
Timepoint [2] 447676 0
Baseline and Week 12 post-commencement of intervention
Secondary outcome [3] 447677 0
Assess the impact of BRP-185 on functional impairment
Timepoint [3] 447677 0
Baseline and Week 12 post-commencement of intervention
Secondary outcome [4] 447678 0
Evaluate the safety and tolerability of BRP-185 compared to placebo (composite outcome)
Timepoint [4] 447678 0
Baseline, Week 2, Week 4, Week 12 post-commencement of intervention
Secondary outcome [5] 448004 0
Assess the impact of BRP-185 on cognitive impairment
Timepoint [5] 448004 0
Baseline and Week 12 post-commencement of intervention

Eligibility
Key inclusion criteria
• Adults aged 18-65 years.
• Diagnosis of Idiopathic Hypersomnia (IH) according to ICSD-3 criteria.
• Epworth Sleepiness Scale (ESS) score more than or equal to 10 at baseline.
• Total sleep time (TST) more than or equal to 11 hours per 24 hours based on sleep logs or actigraphy.
• Persistent sleep inertia symptoms causing daily functional impairment.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of narcolepsy (Type 1 or Type 2) based on MSLT and hypocretin levels.
• Untreated obstructive sleep apnoea (OSA) (AHI > 15).
• Use of stimulants or wake-promoting agents within 14 days prior to randomization.
• History of seizure disorders or conditions that lower the seizure threshold.
• Use of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomization.
• Uncontrolled cardiovascular disease or hypertension.
• Pregnant or lactating women.
• Active substance use disorder within the last 6 months.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple central randomisation by computer that is stratified by country to ensure equal number of active and placebo in all countries where trial is happening
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
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2028
Actual
Date of last data collection
Anticipated
1/10/2028
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318987 0
Commercial sector/Industry
Name [1] 318987 0
Bioron Pharma
Country [1] 318987 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bioron Pharma
Address
Country
Australia
Secondary sponsor category [1] 321453 0
None
Name [1] 321453 0
Address [1] 321453 0
Country [1] 321453 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317591 0
Bellberry Human Research Ethics Committee K
Ethics committee address [1] 317591 0
Ethics committee country [1] 317591 0
Australia
Date submitted for ethics approval [1] 317591 0
04/03/2025
Approval date [1] 317591 0
11/04/2025
Ethics approval number [1] 317591 0
2025-03-340

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

Contacts
Principal investigator
Name 141518 0
Dr Arul Sivanesan
Address 141518 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 141518 0
Australia
Phone 141518 0
+610422156206
Fax 141518 0
Email 141518 0
[email protected]
Contact person for public queries
Name 141519 0
Arul Sivanesan
Address 141519 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 141519 0
Australia
Phone 141519 0
+610422156206
Fax 141519 0
Email 141519 0
[email protected]
Contact person for scientific queries
Name 141520 0
Arul Sivanesan
Address 141520 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 141520 0
Australia
Phone 141520 0
+610422156206
Fax 141520 0
Email 141520 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.