The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS). The secondary objectives of this study are to assess the efficacy, safety and tolerability, impact on quality of life, and impact on physical activity of cannabidiol oral solution in patients with PWS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
Oral solution
Matching oral solution
University of Arizona
Tucson, Arizona, United States
Rady Children's, UC San Diego
San Diego, California, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas , Medical Center
Kansas City, Kansas, United States
Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT)
The HQ-CT measures hyperphagia by Prader-Willi syndrome (PWS)-specialized clinicians. The HQ-CT generates a score ranging from 0 to 36, where a higher score represents more severe abnormal food related behaviors. The change from baseline was calculated from two time points as the value at the later time point minus the value at the earlier time point: value at Week 13 minus value at Baseline.
Time frame: Baseline, Week 13
Change From Baseline In Total Body Weight
Total body weight refers to participants' weight throughout the study. The change from baseline was calculated from two time points as the value at the later time point minus the value at the earlier time point: value at Week 13 minus value at Baseline.
Time frame: Baseline, Week 13
Responder Rate From Baseline Through Study Completion
A responder was defined as having a 6 or more points decrease in HQ-CT score.
Time frame: Baseline up to Week 13
Change In Patient Global Impression Of Change (PGI-C) Questionnaire
The change in PGI-C scores at Week 3, Week 9, and Week 13 of the participant are evaluated.
Time frame: Week 3, Week 13
Change From Baseline In The Three Factor Eating Questionnaire - 18-item Version (TFEQ-R18)
The change from baseline to Week 13 of the participant's TFEQ-R18 score is evaluated.
Time frame: Baseline, Week 13
Change From Baseline In Quality Of Life [Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction And Positive Affect Questionnaires]
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Johns Hopkins University
Baltimore, Maryland, United States
The University of Oklahoma Health Sciences Center
Tulsa, Oklahoma, United States
Institute for Research and Innovation | MultiCare Health System
Tacoma, Washington, United States
The change from baseline to Week 13 of the participant's quality of life (PROMIS life satisfaction and positive affect questionnaire) score is evaluated.
Time frame: Baseline, Week 13
Change From Baseline In Physical Activity (PROMIS Physical Activity And Fatigue Questionnaires)
The change from baseline to Week 13 of the participant's physical activity (PROMIS physical activity and fatigue questionnaires) score is evaluated.
Time frame: Baseline, Week 13