AutismPhase 2NCT04517799
Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
A Phase 2 study testing Epidiolex in people with Autism and Autism Spectrum Disorder, run by University of California, San Diego at 1 site in United States.
Trial summary
There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. Read more about this study
- Who is it for?
- Ages 7 to 14 years, men only
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Epidiolex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Boys ages 7-14 years
- Confirmed diagnosis of autism based on ADOS testing
- Autism severity assessed as severe with substantial behavioral problems
- Severity of symptoms will be based on a number of criteria:
- Aggressive and/or self-injurious (SIBs) behaviors occur almost daily (more than 6 times per week) in any situation (home, school, clinic, etc.).
- Frequent (daily), persistent (lasting at least 5-10 minutes and repeated through the day) stereotypies (repetitive behaviors such as hand flapping, running in circles, jumping repeatedly, waving fingers in front of eyes)
- Pervasive hyperactivity (child is so physically active that he cannot sit for meals or school work, is moving all the time, jumping off furniture, climbing onto furniture, etc.)
- One of more of the above activities is deemed to contribute significantly to child's inability to function by parental report and with clinician agreement based on history and/or direct observation
Who cannot join
- the presence of epilepsy
- a known genetic condition such as tuberous sclerosis
- other significant health issues such as cardiac disease, presence of known congenital brain malformation, or a history of central nervous system infection.
- children who are on anticonvulsant medications such as clobazam or valproic acid will also be excluded because of potential drug-drug interactions. At the time of screening, each child's medication list will be checked for drugs that are known to cause interactions with cannabidiol.
- children with an allergy to any components of the study drug
- children who are taking CBD from another source, unless parents are willing to stop the treatment for at least 4 weeks prior to entering the study. CBD and other cannabinoid blood levels will be performed at baseline and if CBD is detected in the blood, the child will be not be included in the study.
- children who might travel out of the area for a significant time during the study
- children who recently participated in another investigational drug trial may be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: A Double-Blind, Crossover Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.
Read the detailed description
Children with autism spectrum disorders (ASD) may have severe behavior problems, including aggression, self-injurious behaviors, severe and persistent stereotypic behaviors, and extreme hyperactivity, which limit their ability to function socially and academically and are often disruptive to family life as well. Cannabidiol (CBD), a compound originally derived from the cannabis plant but without the psychoactive effects found in cannabis, has been shown to be safe and effective in the treatment of children with severe epilepsy. Two non-controlled studies using CBD from local sources have demonstrated improvements in behavior in children with autism. Parents of autistic children have been using CBD products in an unregulated fashion with unknown dosing with anecdotal reports of improved behavior. This study will use EPIDIOLEX (EPX), a purified CBD oral solution that was FDA approved in June 2018 to treat severe forms of pediatric epilepsy. Study subjects will be 30 boys between 7 and 14 years of age with autism who have severe behavior problems. Every child will undergo baseline clinical evaluation, neuropsychological, behavioral, cognitive, and language testing, will have a test of brain wave activity (EEG) and a brain MRI scan. parents will complete questionnaires on various aspects of their child's behavior. Fifteen children will receive CBD for 8 weeks and 15 will receive a placebo that looks and tastes similar to the CBD (Period 1). All of the baseline tests and questionnaires will then be repeated. After a 4 week washout period, behavioral and cognitive tests and questionnaires will be repeated and then the treatments will be reversed (Period 2). At the end of 8 weeks, all of the baseline tests and questionnaires will be repeated. Study personnel and parents will be blinded to the treatment status of each child. Statistical analyses will be used to determine whether there are significant differences between baseline testing and results after placebo or CBD treatment. Types and severities of adverse events will be tracked to provide information about the safety and tolerability of CBD in this population. If CBD is found to be safe and effective in treating the behavioral problems associated with autism, this would be a major new tool in the treatment of those children that could lead to improved functioning and quality of life for the affected individuals and their families.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Epidiolex, placebo oral solution
- Keywords
- cannabidiol, CBD, autism, autism spectrum disorder
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidiolexDrug
Also called cannabidiol
While in the intervention arm subjects will receive EPIDIOLEX, an oral purified CBD solution developed by GW Pharmaceuticals. The formulation is a 100 mg/mL solution, which allows for easy dose titration and administration even to young children. EPIDIOLEX is naturally-derived CBD, and has been found to have a purity of over 98%. The solution includes a sweetener to make it palatable. Dosing is dependent upon each subject's weight.
The dosage will be titrated over time as follows:
Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change.
placebo oral solutionDrug
GW has developed a placebo that is identical in color and taste, and will be administered in the same volume as the CBD, so that parents and investigators should not be able to detect differences between the 2 treatments. Dosing is dependent upon each subject's weight.
The dosage will be titrated as follows:
Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change.
| Study group | Role | What they receive |
|---|---|---|
| cannabidiol | Experimental | cannabidiol arm Receives: Drug: Epidiolex |
| placebo | Placebo comparator | placebo arm Receives: Drug: placebo oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on Repetitive Behavior Scale-Revised (RBS-R)
This scale aims to capture the frequency and severity of the repetitive and restricted behaviors that are a common feature in individuals with autism spectrum disorders. The RBS-R has been validated and has been shown to have high internal consistency and inter-rater reliability when used in outpatient settings. There are 5 subscales: Stereotypic Behavior, Self-Injurious Behavior, Compulsive Behavior, Ritualistic/Sameness Behavior, and Restricted Interests. This scale will be administered to the parent or caregiver, who will report on the child's recent behaviors. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Child Behavior Checklist (CBCL)
The CBCL is a widely used test that assesses problem behaviors in children by posing questions to the parent or caregiver. It poses questions about a wide range of potential negative behaviors including aggression, rule-breaking, and social problems. The school-aged scale, which will be used in this study, consists of 118 questions. The CBCL has 8 syndrome scales, including Aggressive Behavior, Anxiety/Depressed, Attention Problems, Rule-breaking, Somatic Complaints, Social Problems, Thought Problems, and Withdrawn/Depressed. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Autism Diagnostic Observation Scale- 2 (ADOS-2)
This a widely used scale that diagnoses autism spectrum disorders across individuals with a broad range of ages, developmental levels, and language abilities. It is a semi-structured assessment and consists of behavioral observation and coding of relevant behaviors. The ADOS-2 evaluates communication, social interaction, and imaginative play. The child is asked to complete various activities and then rated on their performance by the tester. Time of administration is 40-60 minutes. Range of scores is 1-10. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Secondary outcomes (5)
Total Score on Aberrant Behavior Checklist (ABC)
This checklist relies upon parent/caregiver report to assess problematic behaviors. These behaviors are divided into 5 subscales: irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Social Responsiveness Scale
Formerly known as the Social Reciprocity Scale, this 65 item questionnaire takes a quantitative approach to measuring autistic symptomatology. It obtains "first-hand" ratings from individuals (in this case, parents) who have observed the child in naturalistic social settings. The SRS poses questions about a child's ability to engage in emotionally appropriate reciprocal social interactions, It generates a singular severity score for autistic social impairment (higher score equates with greater severity), use of which has been validated by extensive factor and cluster analyses among clinical and nonclinical populations.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Peabody Picture Vocabulary test (PPVT-4)
The PPVT-4 is a measure of receptive vocabulary for Standard American English. For this study we will use standard scores.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Expressive One Word Picture Vocabulary test, Fourth Edition (EOWPVT-4)
This test assesses the individual's ability to name a variety of objects, actions, and concepts. Participants in this study are expected to have limited verbal abilities. This test will evaluate the degree of impairment at baseline and then following treatment. Administration takes less than twenty minutes.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Children's Sleep Habits Questionnaire (CSHQ)
This is a retrospective, 45-item parent questionnaire that has been used in a number of studies to examine sleep behavior in young children. Thirty-two items on the CSHQ are grouped into 8 subscales relating to a number of key sleep domains: (1) bedtime resistance (6 items); (2) sleep-onset delay (1 item); (3) sleep duration (3 items); (4) sleep anxiety (4 items); (5) night wakings (3 items); (6) parasomnias (7 items); (7) sleep-disordered breathing (2 items); and (8) daytime sleepiness (8 items). Parents are asked to recall sleep behaviors occurring during a typical recent week. A higher score is indicative of more disturbed sleep.
Measured: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Jun 2020
- Primary completion30 Aug 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Wholistic Research and Education Foundation, Center for Medicinal Cannabis Research
- Responsible party
- Principal investigator, Doris Trauner, MD, University of California, San Diego
- Investigators
- Doris Trauner, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517799
- Sponsor's protocol ID
- 181455
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2020
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Once all data analyses have been completed, individual participant data may be available to be shared with other researchers on a case by case basis. Members of the core research team will review all requests. Data will be shared on RedCap or similar platform depending on type of data requested.
Publications
Trauner D, Umlauf A, Grelotti DJ, Fitzgerald R, Hannawi A, Marcotte TD, Knight C, Smith L, Paez G, Crowhurst J, Brown A, Suhandynata RT, Lund K, Menlyadiev M, Grant I. Cannabidiol (CBD) Treatment for Severe Problem Behaviors in Autistic Boys: A Randomized Clinical Trial. J Autism Dev Disord. 2025 May 24:10.1007/s10803-025-06884-y. doi: 10.1007/s10803-025-06884-y. Online ahead of print.
PubMed 40410546
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Crossover Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
- ClinicalTrials.gov ID
- NCT04517799
- Acronym / sponsor ID
- 181455
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- cannabidiol, CBD, autism, autism spectrum disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Wholistic Research and Education Foundation, Center for Medicinal Cannabis Research
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.
Detailed description
Children with autism spectrum disorders (ASD) may have severe behavior problems, including aggression, self-injurious behaviors, severe and persistent stereotypic behaviors, and extreme hyperactivity, which limit their ability to function socially and academically and are often disruptive to family life as well. Cannabidiol (CBD), a compound originally derived from the cannabis plant but without the psychoactive effects found in cannabis, has been shown to be safe and effective in the treatment of children with severe epilepsy. Two non-controlled studies using CBD from local sources have demonstrated improvements in behavior in children with autism. Parents of autistic children have been using CBD products in an unregulated fashion with unknown dosing with anecdotal reports of improved behavior. This study will use EPIDIOLEX (EPX), a purified CBD oral solution that was FDA approved in June 2018 to treat severe forms of pediatric epilepsy. Study subjects will be 30 boys between 7 and 14 years of age with autism who have severe behavior problems. Every child will undergo baseline clinical evaluation, neuropsychological, behavioral, cognitive, and language testing, will have a test of brain wave activity (EEG) and a brain MRI scan. parents will complete questionnaires on various aspects of their child's behavior. Fifteen children will receive CBD for 8 weeks and 15 will receive a placebo that looks and tastes similar to the CBD (Period 1). All of the baseline tests and questionnaires will then be repeated. After a 4 week washout period, behavioral and cognitive tests and questionnaires will be repeated and then the treatments will be reversed (Period 2). At the end of 8 weeks, all of the baseline tests and questionnaires will be repeated. Study personnel and parents will be blinded to the treatment status of each child. Statistical analyses will be used to determine whether there are significant differences between baseline testing and results after placebo or CBD treatment. Types and severities of adverse events will be tracked to provide information about the safety and tolerability of CBD in this population. If CBD is found to be safe and effective in treating the behavioral problems associated with autism, this would be a major new tool in the treatment of those children that could lead to improved functioning and quality of life for the affected individuals and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cannabidiol | Experimental | Drug: Epidiolexcannabidiol arm |
| placebo | Placebo comparator | Drug: placebo oral solutionplacebo arm |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Boys ages 7-14 years
- Confirmed diagnosis of autism based on ADOS testing
- Autism severity assessed as severe with substantial behavioral problems
- Aggressive and/or self-injurious (SIBs) behaviors occur almost daily (more than 6 times per week) in any situation (home, school, clinic, etc.).
- Frequent (daily), persistent (lasting at least 5-10 minutes and repeated through the day) stereotypies (repetitive behaviors such as hand flapping, running in circles, jumping repeatedly, waving fingers in front of eyes)
Key exclusion criteria (8 listed)
- the presence of epilepsy
- a known genetic condition such as tuberous sclerosis
- other significant health issues such as cardiac disease, presence of known congenital brain malformation, or a history of central nervous system infection.
- children who are on anticonvulsant medications such as clobazam or valproic acid will also be excluded because of potential drug-drug interactions. At the time of screening, each child's medication list will be checked for drugs that are known to cause interactions with cannabidiol.
- children with an allergy to any components of the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpidiolexAlso: cannabidiolWhile in the intervention arm subjects will receive EPIDIOLEX, an oral purified CBD solution developed by GW Pharmaceuticals. The formulation is a 100 mg/mL solution, which allows for easy dose titration and administration even to young children. EPIDIOLEX is naturally-derived CBD, and has been found to have a purity of over 98%. The solution includes a sweetener to make it palatable. Dosing is dependent upon each subject's weight. The dosage will be titrated over time as follows: Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change. | Drug | cannabidiol |
| placebo oral solutionGW has developed a placebo that is identical in color and taste, and will be administered in the same volume as the CBD, so that parents and investigators should not be able to detect differences between the 2 treatments. Dosing is dependent upon each subject's weight. The dosage will be titrated as follows: Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change. | Drug | placebo |
Primary outcome
Total Score on Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
This scale aims to capture the frequency and severity of the repetitive and restricted behaviors that are a common feature in individuals with autism spectrum disorders. The RBS-R has been validated and has been shown to have high internal consistency and inter-rater reliability when used in outpatient settings. There are 5 subscales: Stereotypic Behavior, Self-Injurious Behavior, Compulsive Behavior, Ritualistic/Sameness Behavior, and Restricted Interests. This scale will be administered to the parent or caregiver, who will report on the child's recent behaviors. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics.
Total Score on Child Behavior Checklist (CBCL)
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
The CBCL is a widely used test that assesses problem behaviors in children by posing questions to the parent or caregiver. It poses questions about a wide range of potential negative behaviors including aggression, rule-breaking, and social problems. The school-aged scale, which will be used in this study, consists of 118 questions. The CBCL has 8 syndrome scales, including Aggressive Behavior, Anxiety/Depressed, Attention Problems, Rule-breaking, Somatic Complaints, Social Problems, Thought Problems, and Withdrawn/Depressed. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics.
Autism Diagnostic Observation Scale- 2 (ADOS-2)
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
This a widely used scale that diagnoses autism spectrum disorders across individuals with a broad range of ages, developmental levels, and language abilities. It is a semi-structured assessment and consists of behavioral observation and coding of relevant behaviors. The ADOS-2 evaluates communication, social interaction, and imaginative play. The child is asked to complete various activities and then rated on their performance by the tester. Time of administration is 40-60 minutes. Range of scores is 1-10. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics.
5 secondary outcomes
Total Score on Aberrant Behavior Checklist (ABC)
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Social Responsiveness Scale
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Peabody Picture Vocabulary test (PPVT-4)
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Expressive One Word Picture Vocabulary test, Fourth Edition (EOWPVT-4)
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Total Score on Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 40410546Trauner D, Umlauf A, Grelotti DJ, Fitzgerald R, Hannawi A, Marcotte TD, Knight C, Smith L, Paez G, Crowhurst J, Brown A, Suhandynata RT, Lund K, Menlyadiev M, Grant I. Cannabidiol (CBD) Treatment for Severe Problem Behaviors in Autistic Boys: A Randomized Clinical Trial. J Autism Dev Disord. 2025 May 24:10.1007/s10803-025-06884-y. doi: 10.1007/s10803-025-06884-y. Online ahead of print.
- Individual participant dataSharing planned: No. Once all data analyses have been completed, individual participant data may be available to be shared with other researchers on a case by case basis. Members of the core research team will review all requests. Data will be shared on RedCap or similar platform depending on type of data requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Trauner, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epidiolex in people with Autism and Autism Spectrum Disorder, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score on Repetitive Behavior Scale-Revised (RBS-R) (time frame: Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.