Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000479404
Ethics application status
Approved
Date submitted
1/05/2025
Date registered
19/05/2025
Date last updated
19/05/2025
Date data sharing statement initially provided
19/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2 Study of BRP-180 in Patients with Narcolepsy
Scientific title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of BRP-180 in Patients with Narcolepsy
Secondary ID [1] 314333 0
BRP-180-0001
Secondary ID [2] 314472 0
CT-2024-CTN-03130-1 v2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Narcolepsy 337298 0
Condition category
Condition code
Neurological 333689 333689 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will consist of a screening, observation period, treatment period, and a follow-up (FU) period.
During the screening and observational period (up to 42 days before begining treatment), participants are expected to complete daily sleep and cataplexy diaries, Daily questionnaires (NSS, PGI-C, QoLN) via study App. a MWT (Maintenance of Wakefulness Test) conducted within 7 days before Baseline (Day 0). Eligibility to the trial is confirmed based on ESS score and/or cataplexy rate.
During the treatment phase (8 weeks), participants are required to self administer the treatment drug (A or B) orally once a day for eight consecutive weeks.:
Treatment A (Test):
150 mg BRP-180, oral capsule -75 mg Bupropion IR + 75 mg Bupropion SR
Treatment B (Test):
225 mg BRP-180, oral capsule -75 mg Bupropion IR + 150 mg Bupropion SR
There will be weekly telehealth appoitments for check-ins, AE monitoring, and diary compliance. Participants are expected to have in-person site visits during weeks 4 & 8 for safety and efficacy assessments. Participants are also required to maintain daily logs via the study app and fill out weekly questionnaires (NSS, PGI-C, QoLN; EQ-5D) also via the study app.
During the follow up phase (4 weeks post treatment), there are Bi-weekly telehealth check-ins with Investigator/Sub-Investigator, continued eDiary and ePRO data collection through the App and final assessments at Week 12.
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] 330947 0
Treatment: Drugs
Comparator / control treatment
Placebo oral capsule
Visually identical oral capsule to Bupropion BRP-180 without API (Bupropion)
Control group
Placebo

Outcomes
Primary outcome [1] 341284 0
Efficacy of chronic administration of low and high dose levels of BRP-180 on wakefulness in patients with Narcolepsy
Timepoint [1] 341284 0
Baseline, Week 8 (primary timepoint) of treatment phase
Secondary outcome [1] 447019 0
Efficacy of chronic administration of low and high dose levels of BRP-180 on cataplexy in patients with Narcolepsy.
Timepoint [1] 447019 0
Measured daily. Change from baseline to Week 8 and Week 12 using the weekly mean of the daily Epworth Sleepiness Scale score (ESS)
Secondary outcome [2] 447020 0
Safety and tolerability of low and high dose levels of BRP-180 chronic administration in patients with Narcolepsy. This will be assessed as a composite outcome.
Timepoint [2] 447020 0
Baseline to Week 4, 8 and 12 in weekly Cataplexy Rate
Secondary outcome [3] 447021 0
Effect of chronic administration of low and high dose levels of BRP-180 on health-related quality of life in patients with Narcolepsy
Timepoint [3] 447021 0
Change from baseline to Week 4, 8 and 12 in the weekly mean of the daily Epworth Sleepiness Scale score

Eligibility
Key inclusion criteria
1. Male or female, older or equal to 18 and below or equal to 65 years (inclusive), body weight equal or more than 50 kg, BMI 18.0 to 32 (inclusive.)
2. Patient is free from clinically significant (in the opinion of the Investigator/Sub-Investigator) illness or disease as determined by their medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory determinations.
3. Diagnosis of Narcolepsy (DSM-5)
4. Must have experienced ESS score 10-18 (calculated as the mean of the daily score recorded for 14 days over the 21 days observation period) and/or 3-7 cataplexy attacks per week during the observation period.
5. Add-on therapy for narcolepsy such as physical therapy, biofeedback therapy, acupuncture therapy, behavioral therapy or herbal remedies, should remain unchanged throughout the duration of trial; if any changes occur they must be reported to the Investigator/Sub-Investigator immediately.
6. Able to discontinue their regular narcolepsy medications for the washout period and throughout the trial.
7. Pulse between 45 and 100 beats per minute (bpm) at screening (inclusive)
8. Supine systolic BP between 90 and 160 mmHg, diastolic BP between 50 and 95 mmHg inclusive, at screening. For the purpose of qualifying any given patient for study participation, out-of-range vital signs may be repeated once.
9. Must not be pregnant, breastfeeding (non-lactating), or planning pregnancy.
10. Female Patients must have negative serum hCG pregnancy test at screening and negative urine test a check-in.
11. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) must be willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration:
a. Simultaneous use of intrauterine contraceptive device without hormone release system placed at least 4 weeks prior to the first study drug administration; or intrauterine contraceptive device with hormone release system placed at least 12 weeks prior to first study drug administration; or oral hormonal contraceptives (minimum 12 week use without issue), and a condom for the male partner.
12. Females of non-childbearing potential must be:
a. Post-menopausal (absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the post menopausal status by documented FSH level equal or more than 40 mIU/mL; or
b. Surgically sterile (complete hysterectomy, bilateral oophorectomy or tubal ligation at least 3 months prior to the first study drug administration).
13. Male Patients who are not vasectomised for at least 3 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first dose and for 90 days after the last dose:
a. Simultaneous use of condom and established use of oral, injected or implanted hormonal contraceptive or placement of intrauterine device (IUD) or intrauterine system (IUS) for the female partner;
14. Male Patients who have had a vasectomy must also be willing to use a condom from the first dose and for 90 days after the last dose.
15. Male Patients must be willing not to donate sperm for 90 days after the last dose.
16. Female patients must be willing not to donate ova for 30 days after the last dose.
17. Willing and able to adhere to all study requirements, including willingness to comply with scheduled visits.
18. Willing to undergo two MWT test (baseline – Visit 2, end of week 8 – Visit 10)
19. Able to understand the study procedures and provide signed and dated patient informed consent form (ICF) to participate in the study prior to screening.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant diagnosis of other sleep disorders other than narcolepsy
2. History of severe allergic or anaphylactic reactions, known intolerance, allergy or hypersensitivity reactions to bupropion.
3. History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
4. Narcolepsy secondary to another neurological pathology or presence of a comorbid neurological pathology (multiple sclerosis, Steinert's myotonic dystrophy, head trauma, epilepsy)
5. History of neurologic conditions such as seizures or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure. A history of childhood febrile seizures is allowed.
6. Presence of current psychiatric condition or psychiatric condition leading to exclusion from the study based on the opinion of the Investigator/Sub-investigator.
7. Malignancy within 5 years of screening visit (excluding non-melanoma skin cancer that has been resected).
8. Current or prior diagnosis of bulimia or anorexia nervosa
9. A calculated creatinine clearance of < 85 mL/minute at screening or pre randomisation according to the equation using Cockcroft and Gault.
10. Liver function tests showing values for ALT or AST > 2.5 times ULN at Screening.
11. Patients with Child-Pugh Class B and C liver disease, and Model for End-Stage Liver Disease (MELD) score = 10
12. Evidence or history of clinically significant (in the opinion of the Investigator/Sub-Investigator) other cardiovascular, pulmonary, neurologic or renal disorders or hepatic, gastrointestinal, oral (difficulty swallowing / taking oral medication), haematological, endocrine, or psychiatric impairment/disorders.
13. Any laboratory test results deemed clinically significant by the Investigator/Sub-Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
14. CSSR-S score = 10 for the Columbia Suicide Severity Rating Scale (C-SSRS).
15. Have undergone surgery requiring or have received (for any reason) anaesthetic within 42 days of Day 0, or planned surgery during the study.
16. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
17. Positive results for the urine drugs of abuse test or a positive alcohol breath test at screening or Day 0.
Screening urine drug test/alcohol breath testing may be repeated once if deemed appropriate by the Investigator/Sub-Investigator.
18. Unwilling or unable to abstain from recreational drug/substance use, from 48 hours before check-in until final study visit. This does not include nicotine containing substances.
19. Use of medications for the timeframes specified below:
a. Use of any over the counter product, herbal product, diet aid, or hormone supplement (except oral contraception pills) and hormone replacement therapy, within 14 days of the first study drug administration (Day 0) and throughout the duration of the study, unless approved by both the Investigator/Sub-Investigator and Medical Monitor (in writing). If necessary, paracetamol (acetaminophen) or ondansetron (or other 5-HT3 receptor antagonist) may be administered with the approval of the Investigator/Sub-Investigator.
b. CNS depressants including opioids, sedative, anxiolytics, hypnotics, neuroleptics, phenothiazines, tranquilisers, skeletal muscle relaxants, sedating antihistamines or cimetidine within 42 days of the first study drug administration (Day 0).
c. Monoamine Oxidase Inhibitors (MAOIs) within 42 days of the first study drug administration (Day 0).
d. Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritonavir) within 42 days of the first study drug administration (Day 0). Thirty-day washout from these medications is required.
e. Natural health products (including herbal remedies such as St. John’s wort, homeopathic and traditional medicines), and antacid preparations within 42 days of the first dose administration (Day 0) and throughout the duration of the study. Vitamins and dietary supplements used as nutritional supplements in non-therapeutic doses (judged by the qualified Investigator/Sub-Investigator) must be stopped at least 14 days before the first study drug administraion and throughout the duration of the study).
f. Any drugs known to induce or inhibit hepatic and renal drug metabolism within 42 days of the first study drug administration (Day 0) and throughout the duration of the study.
g. Use of any enzyme-modifying drugs and/or other products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) within 42 days of the first study drug administration (Day 0) and throughout the duration of the study.
h. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month or 5 half-lives of the specific drug/biologic (whichever is longer) prior the first study drug administration (Day 0) and throughout the duration of the study.
20. Any reason which, in the opinion of the Investigator/Sub-Investigator, would prevent the patient from participating in the study.

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2028
Actual
Date of last data collection
Anticipated
31/08/2028
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318852 0
Commercial sector/Industry
Name [1] 318852 0
Bioron Pharma
Country [1] 318852 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bioron Pharma
Address
Country
Australia
Secondary sponsor category [1] 321308 0
None
Name [1] 321308 0
Address [1] 321308 0
Country [1] 321308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317468 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317468 0
Ethics committee country [1] 317468 0
Australia
Date submitted for ethics approval [1] 317468 0
19/09/2024
Approval date [1] 317468 0
27/09/2024
Ethics approval number [1] 317468 0

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

Contacts
Principal investigator
Name 141138 0
Dr Arul Sivanesan
Address 141138 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 141138 0
Australia
Phone 141138 0
+610422156206
Fax 141138 0
Email 141138 0
[email protected]
Contact person for public queries
Name 141139 0
Arul Sivanesan
Address 141139 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 141139 0
Australia
Phone 141139 0
+610422156206
Fax 141139 0
Email 141139 0
[email protected]
Contact person for scientific queries
Name 141140 0
Arul Sivanesan
Address 141140 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 141140 0
Australia
Phone 141140 0
+610422156206
Fax 141140 0
Email 141140 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.