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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 August 2024 |
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Main ID: |
NCT05657860 |
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Date of registration:
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12/12/2022 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
PWS-GXR |
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Scientific title:
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A Double Blind, Placebo Controlled, Fixed-Flexible Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome |
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Date of first enrolment:
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December 17, 2020 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05657860 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Deepan Singh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maimonides Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of PWS confirmed by genetic testing documentation
- Rating of moderate or above on the Clinical Global Impression- Severity Scale
Exclusion Criteria:
- Subjects with positive pregnancy test, swallowing difficulty, and/or presenting with
active psychosis or mania will be excluded
- Subjects currently taking guanfacine extended release
- Patients with lactose intolerance
- Individuals with pre-existing, clinically significant bradycardia (< 8 years: <64
bpm; 8 to 12 years: <59 bpm; 12 to 16 years: <53 bpm) or hypotension, defined as 5th
percentile for height and gender,26 will be excluded from the study.
- Subjects receiving antipsychotic medications due to a documented history of
psychosis or bipolar disorder will be allowed to continue taking the medication
without dosage modification.
- Growth hormone, thyroid hormone replacement treatment, and non-psychiatric medicines
will be allowed to continue.
- N-Acetyl Cysteine and anticonvulsant medication (only if prescribed for seizures)
will be allowed to continue, with specific instructions to not make any dosage
changes during the clinical trial.
Age minimum:
6 Years
Age maximum:
35 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Congenital Abnormalities
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Neurobehavioral Manifestations
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Behavioral Symptoms
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Nervous System Diseases
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Neurologic Manifestations
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Pathologic Processes
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Obesity
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Overnutrition
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Skin-Picking
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Genetic Diseases, Inborn
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Physiological Effects of Drugs
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Abnormalities, Multiple
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Neurotransmitter Agents
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Chromosome Disorders
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Self-Injurious Behavior
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Aggression
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Antihypertensive Agents
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Intellectual Disability
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Molecular Mechanisms of Pharmacological Action
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Nutrition Disorders
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Intervention(s)
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Other: Placebo
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Drug: Guanfacine Extended Release
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Primary Outcome(s)
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Clinical Global Impression- Improvement change from baseline to week 16
[Time Frame: 16 Weeks]
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Secondary Outcome(s)
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A change in Aberrant Behavior Checklist from baseline to week 16
[Time Frame: 16 Weeks]
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A change in Modified Overt Aggression Scale from baseline to week 16
[Time Frame: 16 Weeks]
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A change in Self-Injury Trauma Scale from baseline to week 16
[Time Frame: 16 Weeks]
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Secondary ID(s)
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2020-11-03-MMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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