Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000879460
Ethics application status
Approved
Date submitted
6/11/2024
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled 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] 312059 0
BRP-180-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Narcolepsy 333668 0
Condition category
Condition code
Neurological 330356 330356 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a double-blind, multicenter, parallel arm study of low (150mg once daily) and high (225mg once daily) dose levels of BRP-180 as an oral capsule evaluating the change in wakefulness and cataplexy in patients with Narcolepsy.

This trial will consist of 3 study periods.

Screening, Washout Period and Observation Period: Day -42 to Day 0. Sleepiness and cataplexy diary recording (at least 14 days of all questionnaires recording over 21 days prior Day 0).

Treatment Period: Weeks 1-8. Parallel arms treatment period. Sleepiness and cataplexy diary recording.

Follow-up Period: Week 9-12.

The trial will consist of a screening, observation period, treatment period, and a follow-up (FU) period. During the treatment period, patients self-administer the allocated treatment (low doses of BRP-180, high doses of BRP-180, or placebo) once a day for eight consecutive weeks.
Intervention code [1] 328504 0
Treatment: Drugs
Comparator / control treatment
Placebo Controlled - Oral Microcellulose Capsule
Control group
Placebo

Outcomes
Primary outcome [1] 338125 0
To evaluate efficacy of chronic administration of low and high dose levels of BRP-180 in the change of wakefulness in patients with Narcolepsy.
Timepoint [1] 338125 0
Weekly from baseline until end of week 8
Secondary outcome [1] 434604 0
Change in the Narcolepsy Severity Scale (NSS) score in patients with Narcolepsy
Timepoint [1] 434604 0
At Baseline, week 4 and 8 post randomisation
Secondary outcome [2] 441457 0
Change in number of cataplexy events in patients with Narcolepsy
Timepoint [2] 441457 0
At Baseline, week 4 and 8 post randomisation
Secondary outcome [3] 445164 0
Change in the Patient global impression of change (PGI-C score) in narcolepsy patients
Timepoint [3] 445164 0
At baseline, week 4 and week 8
Secondary outcome [4] 445165 0
Change from baseline in a Quality of Life in Narcolepsy (QoLN) score at Weeks 4 and 8
Timepoint [4] 445165 0
At baseline, week 4 and week 8

Eligibility
Key inclusion criteria
1. Male or female, aged 18 to 65 years (inclusive), body weight greater than 50 kg, BMI 18.0 to 32.0, 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 of 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 160mmHg, diastolic BP between 50 and 95mmHg 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 postmenopausal status by documented FSH level greater than 40mIU/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. 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 greater than 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 greater than 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 or 150 mL of wine, 375mL of mid strength beer, or 30mL 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 42days 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)
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
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
25/08/2025
Actual
Date of last participant enrolment
Anticipated
3/09/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316419 0
Commercial sector/Industry
Name [1] 316419 0
Bioron Pharma
Country [1] 316419 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bioron Pharma
Address
Country
Australia
Secondary sponsor category [1] 318588 0
None
Name [1] 318588 0
Address [1] 318588 0
Country [1] 318588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315215 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 315215 0
Ethics committee country [1] 315215 0
Australia
Date submitted for ethics approval [1] 315215 0
27/08/2024
Approval date [1] 315215 0
27/09/2024
Ethics approval number [1] 315215 0

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

Contacts
Principal investigator
Name 134006 0
Dr Arul Sivanesan
Address 134006 0
Vitalis Clinical Research, 456 St Kilda Rd, Melbourne VIC 3004
Country 134006 0
Australia
Phone 134006 0
+61 03 9041 7159
Fax 134006 0
Email 134006 0
[email protected]
Contact person for public queries
Name 134007 0
Darryl Davies
Address 134007 0
iNGENu CRO, 456 St Kilda Rd, Melbourne VIC 3004
Country 134007 0
Australia
Phone 134007 0
+611300 030 380
Fax 134007 0
Email 134007 0
[email protected]
Contact person for scientific queries
Name 134008 0
Darryl Davies
Address 134008 0
iNGENu CRO, 456 St Kilda Rd, Melbourne VIC 3004
Country 134008 0
Australia
Phone 134008 0
+611300 030 380
Fax 134008 0
Email 134008 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.