A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
NCT ID: NCT04252586
Last Updated: 2022-08-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
21 participants
INTERVENTIONAL
2020-02-28
2021-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GWP42003-P
100 milligrams per milliliter (mg/mL) GWP42003-P oral solution, taken twice daily (morning and evening).
GWP42003-P
GWP42003-P presented as an oral solution containing cannabidiol in the excipients sesame oil with anhydrous ethanol, sweetener (sucralose), and strawberry flavoring
Interventions
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GWP42003-P
GWP42003-P presented as an oral solution containing cannabidiol in the excipients sesame oil with anhydrous ethanol, sweetener (sucralose), and strawberry flavoring
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant (if possessing adequate understanding, in the investigator's opinion) and/or the participant(s)/legal representative is willing and able to give informed consent/assent for participation in the trial.
* Participant and the participant's caregiver are willing and able (in the investigator's opinion) to comply with all trial requirements (including the completion of all caregiver assessments by the same caregiver throughout the trial).
* Ability to swallow the investigational medicinal product (IMP) provided as a liquid solution, or the ability for the IMP to be delivered via gastrostomy (G) or nasogastric (NG) feeding tube (only G- or NG-tubes made from polyurethane or silicon are allowed).
* Participant and/or parent(s)/legal representative is willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
* Participant and/or parent(s)/legal representative is willing to allow the participant's primary care practitioner (if the participant has one) and consultant (if the participant has one) to be notified of participation in the trial, if the primary care practitioner/consultant is different from the investigator.
Exclusion Criteria
* Participant met during the RCT the criteria for permanent IMP discontinuation (unless in the case of an adverse event \[AE\], if the AE was not considered related with the IMP; participants that met alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevations discontinuation criteria must be excluded).
* Females of childbearing potential, unless willing to ensure that they or their partner use a highly effective method of birth control (e.g., combined \[estrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, or transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, or implantable\], intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the trial and for 3 months after the last dose
* Participant has been previously enrolled and dosed in this trial.
* Participant is unwilling to abstain from donation of blood during the trial.
* Male participants who are fertile (i.e., after puberty unless permanently sterile by bilateral orchidectomy) and with a partner of childbearing potential unless agree to ensure that they use male contraception (e.g., condom) or remain sexually abstinent during the trial and for 3 months after the last dose
2 Years
18 Years
ALL
No
Sponsors
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GW Pharmaceuticals Ltd
INDUSTRY
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Birmingham, Alabama, United States
Clinical Trial Site
La Jolla, California, United States
Clinical Trial Site
Aurora, Colorado, United States
Clinical Trial Site
Chicago, Illinois, United States
Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Saint Paul, Minnesota, United States
Clinical Trial Site
St Louis, Missouri, United States
Clinical Trial Site
The Bronx, New York, United States
Clinical Trial Site
Cincinnati, Ohio, United States
Clinical Trial Site
Philadelphia, Pennsylvania, United States
Clinical Trial Site
Greenwood, South Carolina, United States
Clinical Trial Site
Nashville, Tennessee, United States
Clinical Trial Site
Houston, Texas, United States
Clinical Trial Site
Perth, , Australia
Clinical Trial Site
South Brisbane, , Australia
Clinical Trial Site
Toronto, , Canada
Clinical Trial Site
Vancouver, , Canada
Clinical Trial Site
Genova, , Italy
Clinical Trial Site
Messina, , Italy
Clinical Trial Site
Milan, , Italy
Clinical Trial Site
Rome, , Italy
Clinical Trial Site
Siena, , Italy
Clinical Trial Site #1
Barcelona, , Spain
Clinical Trial Site #2
Barcelona, , Spain
Clinical Trial Site #1
Madrid, , Spain
Clinical Trial Site #2
Madrid, , Spain
Clinical Trial Site
Valencia, , Spain
Clinical Trial Site
Edinburgh, , United Kingdom
Clinical Trial Site
Liverpool, , United Kingdom
Clinical Trial Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001605-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GWND19002
Identifier Type: -
Identifier Source: org_study_id
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