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Trial registered on ANZCTR


Registration number
ACTRN12624001162505
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
low dose naltrexone in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long coronavirus disease (long COVID) symptoms
Scientific title
Low Dose Naltrexone for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long COVID Condition
Secondary ID [1] 311507 0
Nil
Universal Trial Number (UTN)
Trial acronym
TreatMELC study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) 332843 0
Long COVID 332844 0
Condition category
Condition code
Other 329558 329558 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Infection 331631 331631 0 0
Other infectious diseases
Neurological 331632 331632 0 0
Other neurological disorders
Respiratory 331633 331633 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will start at 1.5mg/day and will increase their dose by 1.5mg/day weekly until their maximum dose is reached (target 4-6mg/day) for 12 weeks. In this clinical trial, Naltrexone will be administered to all ME/CFS and long COVID-19 who meet the recruitment criteria from the clinicians.
Low dose naltrexone will be administered in oral capsules. Placebo participants will receive an exact replica capsule. LDN and placebo capsule will be distributed to participants via post.
The study treatment will be received by the Wesley Hospital Pharmacy designated staff, handled, and stored safely within a secure location to which only pharmacy staff have access. Upon receipt, all investigational products will be stored according to the instructions specified on the labels. The investigators will maintain an accurate record of the shipment and dispensing of study treatment in a drug accountability log. Monitoring of drug accountability will be performed by the study investigators. Participants will keep a drug diary for daily completion for investigators to monitor.
Participants will be asked to return all unused study treatments and package at the end of either a dose escalation, end of the study trial, or discontinuation of the treatment. Returned investigational products will be assessed for compliancy.
Compliance will be assessed by the investigators at the end of each month using pill return counts and information provided by the patient. This information should be captured in the source documents at each visit. All study treatment dispensed and returned must be recorded in the drug accountability log. The site will also be required to complete the appropriate dosage administration record to report any study drug regimen changes or interruptions.
For all medications (other than study regimen) initiated after the start of the study, the reasons for prescribing the medication, the start date, and, where applicable, the end dates will be recorded in the participant’s file.
Information regarding the administration of rescue medication will be recorded in the participant’s file.
Participants will receive instructions to notify investigators of any new medications they take after the participant has enrolled in the study. All medications, procedures, and significant non-drug therapies (e.g., physical therapy and blood transfusions) administered after the patient has enrolled will be recorded.
Intervention code [1] 327957 0
Treatment: Drugs
Intervention code [2] 327958 0
Early detection / Screening
Comparator / control treatment
Participants in the control group will recieve a placebo gelatin capsule
Control group
Placebo

Outcomes
Primary outcome [1] 337385 0
Change in the Transient receptor potential cation channel subfamily M member 3 (TRPM3) function
Timepoint [1] 337385 0
12 weeks after intervention commencement.
Primary outcome [2] 337386 0
Assess brain function by examining functional connectivity, changes in brain neurochemicals, myelin, iron and brain structure. This will be assessed as a composite outcome
Timepoint [2] 337386 0
12 weeks after intervention commencement
Secondary outcome [1] 431645 0
General quality of life
Timepoint [1] 431645 0
12 weeks after intervention commencement.
Secondary outcome [2] 439669 0
Disability assessment
Timepoint [2] 439669 0
12 weeks after intervention commencement
Secondary outcome [3] 440032 0
ME/CFS symptoms assessment
Timepoint [3] 440032 0
12 weeks after intervention commencement

Eligibility
Key inclusion criteria
i. Aged between 18 and 65 years of age
ii. BMI between 18.5 and 29.9
iii. Diagnosed with ME/CFS by a physician at least 6 months ago.
iv. Diagnosed with Long COVID according to WHO working case definition and present with the following symptoms: cognitive disturbances otherwise known as brain fog, sleep disturbances, and/or body pain. This clinical trial will not assess symptoms including gastrointestinal upset, autonomic or orthostatic intolerances, and respiratory difficulties.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Current respiratory infections
ii. Intercurrent SARS-CoV-2 reinfection during trial period (this will be considered drop-out)
iii. Chronic pain history
iv. Adverse reaction to LDN or compounded constituents
v. Chronic opioid or substitution therapy
vi. Daily opioid use in three months prior to, or during trial
vii. Substance abuse, dependence, addiction
viii. History of drug, alcohol abuse and recreational drugs
ix. Smoking within last 2 years
x. Pregnancy or breastfeeding
xi. Renal dysfunction (eGFR less than or equal to 30 ml/min/1.73m2), liver dysfunction (ALT or AST greater than 300 IU/L).
xii. Active cancer.
xiii. Inflammatory (rheumatological, GIT, dermatological) or neurological condition (demyelinating).
xiv. Neuroimmune modulators: DMARDs, steroids, minocycline, metformin.
xv. Major psychiatric history, self-harm.
xvi. Language, cognition, no computer literacy.

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)
Allocation is concealed: central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2024
Actual
Date of last participant enrolment
Anticipated
12/06/2029
Actual
Date of last data collection
Anticipated
14/10/2029
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 315797 0
University
Name [1] 315797 0
Griffith University
Country [1] 315797 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 318054 0
None
Name [1] 318054 0
Address [1] 318054 0
Country [1] 318054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314655 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 314655 0
https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
Ethics committee country [1] 314655 0
Australia
Date submitted for ethics approval [1] 314655 0
28/05/2024
Approval date [1] 314655 0
03/09/2024
Ethics approval number [1] 314655 0

Summary
Brief summary
There is no laboratory-based diagnostic test and universally accepted treatment for ME/CFS and Long COVID, instead diagnosis follows fulfilment of a diagnostic criteria. The study aims to determine if treatment with Low Dose Naltrexone (LDN) improves ion channels function, fatigue, cognitive, neurological symptoms, and health-related quality-of-life (HRQoL) in adults with ME/CFS and Long COVID. If this is the case, Low Dose Naltrexone (LDN) may offer a safe and cost-effective treatment for ME/CFS and Long COVID.
The investigational production Low Dose Naltrexone (LDN) will be manufactured, packaged, labelled, coded, stored, supplied, and handled in accordance with the requirements of sections 5.13 and 5.14 of the Therapeutic Goods Administration’s Integrated Addendum. Specifically, Low Dose Naltrexone (LDN) will be manufactured in accordance with good manufacturing practices (GMP) and will be coded or labelled by the compounding pharmacy. While Low Dose Naltrexone (LDN) and placebo will be blinded, a coding system will be implemented to enable rapid identification of the product for safety reasons. Specifically, Low Dose Naltrexone (LDN) capsules are to be stored at room temperature in their original container for up to six months. Low Dose Naltrexone (LDN) will be labelled with a specific expiration date by the compounding pharmacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132302 0
Prof Sonya Marshall-Gradisnik
Address 132302 0
G40 Griffith Health Centre, Griffith University, Parklands Drive Gold Coast QLD 4222
Country 132302 0
Australia
Phone 132302 0
+61 0756780725
Fax 132302 0
Email 132302 0
[email protected]
Contact person for public queries
Name 132303 0
Sonya Marshall-Gradisnik
Address 132303 0
G40 Griffith Health Centre, Griffith University, Parklands Drive Gold Coast QLD 4222
Country 132303 0
Australia
Phone 132303 0
+61 0756780725
Fax 132303 0
Email 132303 0
[email protected]
Contact person for scientific queries
Name 132304 0
Sonya Marshall-Gradisnik
Address 132304 0
G40 Griffith Health Centre, Griffith University, Parklands Drive Gold Coast QLD 4222
Country 132304 0
Australia
Phone 132304 0
+61 0756780725
Fax 132304 0
Email 132304 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Fully de-identified study data underlying published results.
When will data be available (start and end dates)?
Beginning 1 year after the end of study data collection, and for up to 5 years post completion of study data collection.
Available to whom?
On a case-by-case basis at the discretion of the study sponsor.
Available for what types of analyses?
Group and paired analysis.
How or where can data be obtained?
Access subject to approval by Principal Investigator
Email: [email protected]


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.