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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03649477
Registration number
NCT03649477
Ethics application status
Date submitted
24/08/2018
Date registered
28/08/2018
Date last updated
26/07/2022
Titles & IDs
Public title
Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
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Scientific title
Phase 3, Randomized, Double-Blind, Placebo-Controlled, 8-week Clinical Study to Assess the Efficacy, Safety, and Tolerability, of Intranasal Carbetocin (LV-101) in Prader-Willi Syndrome (PWS) With Long Term Follow-Up (CARE-PWS)
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Secondary ID [1]
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LV-101-3-01
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Universal Trial Number (UTN)
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Trial acronym
CARE-PWS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prader-Willi Syndrome
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Mental Health
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Learning disabilities
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 3.2 mg intranasal carbetocin
Treatment: Drugs - 9.6 mg intranasal carbetocin
Treatment: Drugs - placebo
Placebo Comparator: Placebo - matched placebo during first 8-weeks; prospectively randomized 1:1 to either one of the two doses of carbetocin during 56-week follow-up and optional extension periods
Experimental: 3.2 mg of LV-101 - 3.2 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods
Experimental: 9.6 mg of LV-101 - 9.6 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods
Treatment: Drugs: 3.2 mg intranasal carbetocin
three times per day with meals
Treatment: Drugs: 9.6 mg intranasal carbetocin
three times per day with meals
Treatment: Drugs: placebo
three times per day with meals
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hyperphagia Behavior
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Assessment method [1]
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Change in hyperphagia (extreme hunger) as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Total Score versus placebo.
Score range: 0-36; higher scores mean a worse outcome. Reduction in score indicates improvement.
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Timepoint [1]
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Baseline to Week 8
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Primary outcome [2]
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Obsessive and Compulsive Behaviors
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Assessment method [2]
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Change in obsessive and compulsive behaviors as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score versus placebo.
Score range: 0-40; higher scores mean a worse outcome. Reduction in score indicates improvement.
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Timepoint [2]
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baseline to Week 8
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Secondary outcome [1]
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Anxiety
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Assessment method [1]
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Change in participant anxiety as measured by the PWS Anxiety and Distress Questionnaire (PADQ) Total Score versus placebo.
Score range: 0-56; higher scores mean a worse outcome. Reduction in score indicates improvement.
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Timepoint [1]
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Baseline to Week 8
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Secondary outcome [2]
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Global Impression
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Assessment method [2]
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Clinical Global Impression of Change (CGI-C) score versus placebo. Score range: 1-7; higher scores mean a worse outcome. Reduction in score indicates improvement.
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Timepoint [2]
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Week 8
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Secondary outcome [3]
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Hyperphagia Behavior (Subset)
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Assessment method [3]
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Change in hyperphagia as measured by the change in specified subsets of HQ-CT questions versus placebo.
Score range: 0-24; higher scores mean a worse outcome. Reduction in score indicates improvement.
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Timepoint [3]
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Baseline to Week 8
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Eligibility
Key inclusion criteria
- Genetically-confirmed Prader-Willi syndrome
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
participant); provide voluntary, written assent (participants, as appropriate)
- PWS Nutritional Phase 3 (hyperphagic, rarely feels full)
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Minimum age
7
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Living in a group home
- Genetically diagnosed Schaaf-Yang syndrome or other genetic, hormonal, or chromosomal
cognitive impairment
- New food-related interventions, including environment or dietary restrictions, within
1 month of screening
- Dose of any allowed chronic concomitant medications or supplements that have not been
stable for =3 months prior to the study or is not expected to remain stable while
participating in the study; adjustments in growth hormone dose =10% are not
exclusionary
- Presence of cardiovascular disorders, epilepsy, frequent migraines, or severe asthma
- More than 3 episodes of sinusitis in the 12 months prior to Screening Visit or
presence of nasal diseases that may affect deposition of intranasal medication
- Unwilling to abstain from nasal saline, other nasal irrigation, or other intranasal
medications for 2 weeks prior to the Baseline visit and during the 8-week,
placebo-controlled period of the study
- Use of weight loss medication, oxytocin, carbetocin, or vasopressin in the 6 months
prior to screening
- Participation in an interventional research study involving another investigational
medication or device in the 6 months prior to screening or during the study
- Based on the judgment of the Investigator, is unsuitable for the study for any reason,
including but not limited to unstable medical condition, inability to comply with the
protocol, or other risk to subject or to the integrity of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/07/2022
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Sample size
Target
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Accrual to date
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Final
130
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Queensland Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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District of Columbia
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Florida
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Illinois
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Kansas
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Massachusetts
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Minnesota
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Missouri
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Utah
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Levo Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 3 study is designed to test the effectiveness of intranasal carbetocin (LV-101) in
participants with Prader-Willi syndrome (PWS). Carbetocin is an oxytocin analog (a man-made
chemical that is like oxytocin). This study will also evaluate the safety and tolerability of
LV-101.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03649477
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03649477
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