Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001103358
Ethics application status
Approved
Date submitted
4/07/2017
Date registered
28/07/2017
Date last updated
27/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson’s Disease
Scientific title
Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's Disease
Secondary ID [1] 292358 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 303902 0
Insomnia 303903 0
Condition category
Condition code
Neurological 303268 303268 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
clinical trial that involves a single patient, with the patient serving as their own control. N-of-1 trials, or tests, use a multi-cycle, double-blind, randomized controlled trial (RCT) design where each participant is assured of receiving both the study medication and placebo, and thus learns whether the treatment works specifically for him or her.Each participant will undergo 3 pairs of treatment/placebo periods (each period is 2 weeks; each N-of-1 test will last 12 weeks). Treatments will be randomized separately within each pair of periods (e.g. ABBAAB) by the study statistician.Data from day 1 will be discarded to provide a washout period.There will be a two week run-in period, on 3 mg melatonin.Standard scripts will cover dispensing a two week supply of 3 mg melatonin to the patient. Medication instructions will be explained. We will ask patients to complete a sleep diary (with baseline and weekly administration of the PDSS-2) during the two weeks on 3 mg. If the participant’s PDSS-2 scores improve, the test dose will be 3 mg; if the score does not improve, the test dose will be 6 mg. We will use a threshold of -3.44 points change in the PDSS-2 for detecting clinically significant improvement. Patients, clinicians, research staff and outcome assessors will be blinded.
Participants will take either immediate release melatonin or placebo 30 mins before bedtime. Two doses will be available (3 mg or 6 mg) in personalised N-of-1 tests. For both doses, the comparator will be placebo. trial medications are prepared in oral capsule and will be administered sublingual.
Patients will be asked about progress, any queries and adverse events weekly by the RN during follow up phone calls.
Intervention code [1] 298529 0
Treatment: Drugs
Comparator / control treatment
Placebo tablet consists of:
Microcrystalline cellulose (E460)
Maltodextrin
Silicon dioxide (E551)
Hydroxypropyl methylcellulose (E464)
Magnesium stearate (E470b)
Control group
Placebo

Outcomes
Primary outcome [1] 302646 0
Sleep quality measured by PDSS-2.
Timepoint [1] 302646 0
Every fortnight for 12 weeks
Secondary outcome [1] 337133 0
Sleep onset latency (SOL) measured by actigraphy and sleep diary
Timepoint [1] 337133 0
Every Fortnight for 12 weeks
Secondary outcome [2] 337134 0
Sleep-related impairment measured by.NIH PROMIS sleep-related impairment scale
Timepoint [2] 337134 0
Every fortnight for 12 weeks
Secondary outcome [3] 337135 0
Sleep efficiency (proportion of time spent asleep while in bed) measured by actigraphy.
Timepoint [3] 337135 0
Every fortnight for 12 weeks
Secondary outcome [4] 351157 0
Adverse events measured by self-report and graded according to US Department of Health and Human Services (2015). Common terminology criteria for adverse events v5.03 http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf.
Timepoint [4] 351157 0
Every fortnight for 12 weeks

Eligibility
Key inclusion criteria
1. Adult patients 30 years or more with a diagnosis of idiopathic PD according to the UK Brain Bank (Hughes et al, 1992)
2. Patient has claimed chronic sleep difficulty which is impacting his/her life.
3. Score > 5 on the Pittsburgh Sleep Quality Index (PSQI) (Buysse D et al, 1989)
4. If on sedatives or hypnotics, agree not to alter the daily dose of these for the duration of the test.
5. If not on regular sedatives or hypnotics, agree not to commence these treatments during the test.
6. If on Parkinson’s disease or psychotropic medication, doses stable for 1 month before and throughout the course of the study.
7. Able to provide informed consent.
8. Able to understand English.
9. Have a phone.
10. Agree not to drive or operate heavy machinery within 8 hours of ingestion of study medication.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Scores < 28 in Telephone Interview Cognitive Status (TICS) (Brandt J et al, 1988)
2. Has diagnosed sleep apnea or high risk of this (2 or more categories where the score is positive on Berlin questionnaire for sleep apnea risk (Netzer et al, 1999)).
3. Co-morbid psychiatric/neurological diagnoses that may affect sleep, including:
• Acquired brain injury
• Uncontrolled major depression
• Active or untreated post-traumatic stress disorder
• Uncontrolled psychosis or schizophrenia
• Unstable seizure disorder (i.e. seizure in the last 12 months)
• Other relevant medical diseases, malignancy or other progressive neurological
disorder
• Cognitive impairment defined by Standardised Mini Mental State Score < 25/30 (Molloy and Standish, 1997).
4. Known allergy or hypersensitivity to melatonin or previous adverse event from melatonin.
5. Contraindications to melatonin, such as on immunosuppressive drugs or anticoagulant drugs; patients with active or uncontrolled hormonal disorders, or diabetes, or significant active liver disease (determined by clinician), or moderate-severe abnormal kidney function (determined by clinician) or untreated kidney disease, or any blood clotting disorders.
6. Breastfeeding or pregnant women.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
N-of-1 trial
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296910 0
Charities/Societies/Foundations
Name [1] 296910 0
Wesley Medical Research
Country [1] 296910 0
Australia
Funding source category [2] 296915 0
University
Name [2] 296915 0
University of Queensland
Country [2] 296915 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 295913 0
None
Name [1] 295913 0
Address [1] 295913 0
None
Country [1] 295913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298120 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 298120 0
Ground Floor Moorlands House
The Wesley Hospital
451 Coronation Drive, Auchenflower QLD 4066
PO Box 499 Toowong QLD 4066
Ethics committee country [1] 298120 0
Australia
Date submitted for ethics approval [1] 298120 0
06/06/2016
Approval date [1] 298120 0
04/04/2017
Ethics approval number [1] 298120 0
1702

Summary
Brief summary
This study aims to see whether using melatonin assists with sleeping in patients with Parkinson’s Disease.IMET stands for Individual Medication Effectiveness Tests. An IMET is a new way of working out whether the medication is working for the individual taking the medicine. Most projects that test the effectiveness of medicines give information about the effects of that medication on groups of people. IMETs give information about the effectiveness of the medicine only for the person doing the test.

The IMET will take twelve weeks, and use active and placebo (inactive) medication. Placebo and active medication look exactly the same, but the placebo is not active and has no effect. The IMET team will arrange things so that neither you nor your study doctor, will know what medication you will be taking at any one time. But everyone will know that you will be taking either medication for periods of two weeks at a time, and in a random order.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1859 1859 0 0
/AnzctrAttachments/373251-1702 UCH ethics approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 76062 0
Dr Jane Nikles
Address 76062 0
University of Queensland ,
UQCCR
Building 71/918 RBWH Herston, Brisbane QLD 4029
Country 76062 0
Australia
Phone 76062 0
+61 7 334 65025
Fax 76062 0
Email 76062 0
[email protected]
Contact person for public queries
Name 76063 0
Dr Jane Nikles
Address 76063 0
University of Queensland
UQCCR
Building 71/918 RBWH Herston, Brisbane QLD 4029
Country 76063 0
Australia
Phone 76063 0
+61 7 334 65025
Fax 76063 0
Email 76063 0
[email protected]
Contact person for scientific queries
Name 76064 0
A/Prof John O’Sullivan
Address 76064 0
University of Queensland
St Andrew’s Wesley medical research
Level 2
Place
33 North Street
SPRING HILL QLD 4000
Country 76064 0
Australia
Phone 76064 0
+617 3832 0501
Fax 76064 0
Email 76064 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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