A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2022-10-31

Brief Summary

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This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011 in order to select 1 or 2 dose level(s) for further evaluation in the Phase 3 part of the study. In Phase 3, the primary objective was to assess the effect of RAD011 on hyperphagia-related behavior in participants with PWS.

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Detailed Description

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Conditions

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Prader-Willi Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RAD011 40 milligrams per kilogram (mg/kg)

Participants were administered 40 mg/kg of RAD011 orally daily with food.

Group Type ACTIVE_COMPARATOR

RAD011

Intervention Type DRUG

Cannabidiol Oral Solution (containing synthetic cannabidiol)

RAD011 20 mg/kg

Participants were administered 20 mg/kg of RAD011 orally daily with food.

Group Type ACTIVE_COMPARATOR

RAD011

Intervention Type DRUG

Cannabidiol Oral Solution (containing synthetic cannabidiol)

RAD011 10 mg/kg

Participants were administered 10 mg/kg of RAD011 orally daily with food.

Group Type ACTIVE_COMPARATOR

RAD011

Intervention Type DRUG

Cannabidiol Oral Solution (containing synthetic cannabidiol)

Placebo

Participants were administered a placebo matching to RAD011, orally daily with food.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo for RAD011

Interventions

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RAD011

Cannabidiol Oral Solution (containing synthetic cannabidiol)

Intervention Type DRUG

Placebo

Matching Placebo for RAD011

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females between 8 and 65 years of age (inclusive) at Screening.
* Genetically confirmed diagnosis of PWS. Documentation of genetically confirmed diagnosis of PWS is acceptable.
* The same caregiver is available to complete the questionnaire throughout the duration of the study.
* After completion of the Tolerability period, participants will have a mean Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score ≥13 and a decrease of HQ-CT score no more than 7 during Tolerability (run-in) period.
* If receiving growth hormone, psychotropic therapy, metabolic treatments that could affect appetite (including metformin), and other treatment including thyroid hormone, must be on the same medication and dose for at least 90 days prior to consent/assent

Exclusion Criteria

* Known use of cannabis or cannabinoid containing products (including topical products) within 90 days prior to consent/ assent.
* Use of prescription or over-the-counter weight loss agents within 90 days prior to consent/assent.
* Implementation of new food or environmental restrictions within 90 days of consent/ assent.
* If living in a group home, participant spends less than 25 waking hours with their caregiver per week.
* Uncontrolled chronic conditions (diabetes, sleep apnea, etc.) as determined by the Investigator.

Minimum Eligible Age

8 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No