Neurodevelopmental Disorders With Severe Self-injuriesPhase 2CBD-SIBNCT07564245
Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders.
A Phase 2 study testing Cannabidiol in people with Neurodevelopmental Disorders With Severe Self-injuries, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Self-injuries includes repetitive actions directed at oneself, such as biting, hitting, hitting one's head or limbs, slapping oneself, pulling one's hair, or hitting oneself in the eyes, which can lead to severe injury. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Neurodevelopmental Disorders With Severe Self-injuries
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- May 2026to Feb 2030
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 5 years and 17 years 6 months;
- Weight between 12 and 49.9 kg;
- Clinical diagnosis of severe neurodevelopmental disorder including severe to profound intellectual developmental disorder, characterized in the DSM-5 by a need for help with any daily activity (meals, dressing, toileting, elimination) and the need for constant supervision;
- Severe self-injuries during the last 7 days defined by BPI-01, i.e.:
- at least one type of self-injuries assessed as severe intensity occurring at least once every 3 hours while awake or
- at least two types of self-injuries assessed as severe intensity occurring at least once every 6 hours each while awake;
Show all 12Show fewer
- Self-injuries refractory to treatment with atypical neuroleptic (RISPERIDONE, ARIPIPRAZOLE, etc.) at a dosage deemed effective by the investigator in view of the patient's weight, age and background, for a minimum duration of 30 days (except in the case of poor tolerance by the patient);
- No change in drug and non-drug treatments such as rehabilitative care (psychomotricity, occupational therapy, speech therapy, intervention by a specialist educator) for at least one month;
- In WOCBP and with active sexual life: negatives hCG and use of highly effective contraceptive measure until 18 days after the end of the treatment.
- The participant has a caregiver who can reliably accompany him/her to all clinic visits, provide reliable assessments, help him/her to comply with study requirements, and interact with him/her on a regular basis.
- Signature of Consent of both holders of parental authority;
- Affiliation to social security regimen.
Who cannot join
- 1. Underweight corresponding to a body mass index below the IOTF 18.5 curve on the International Obesity Task Force's body mass index curves for girls and boys 2. Hypersensitivity to the active substance (cannabidiol) or to any of the excipients (refined sesame oil, anhydrous ethanol, sucralose, strawberry flavor, benzyl alcohol); 3. Treatment with or consumption of cannabidiol in the 12 weeks prior to inclusion; 4. Consumption of cannabis in the 12 weeks prior to inclusion; 5. Usual treatment (excluding treatment of self-injuries) containing molecules interacting with cannabidiol (rifampicin, carbamazepine, enzalutamide, mitotane, St. John's wort, clobazam, valproate, stiripentol, phenytoin, lamotrigine, everolimus, theophylline, tizanidine, bupropion, efavirenz, diflunisal, propofol, fenofibrate, gemfibrozil, morphine, lorazepam, repaglinide, warfarin, sirolimus, tacrolimus, digoxin); 6. Elevated transaminases > 3N or total bilirubin > 2N; 7. Known current heart failure; 8. Known current terminal renal failure (GFR < 15 ml/min/1.73 m2); 9. Known current moderate or severe hepatic insufficiency (Child-Pugh B or C); 10. Known current epilepsy or history of epilepsy, even stabilized, requiring treatment currently or not, whatever the type; 11. Pregnancy or breastfeeding; 12. Inability of the patient or entourage to comply with the study protocol; 13. Patient currently participating in another interventional research (category 1 or 2), clinical trial or clinical investigation, or who are in the exclusion period following him/her participation in another study of this type, as defined in the protocol of that study.
- 14. Participant related to a person involved in the study at the investigational site
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013
David COHEN, MD, PHD, david.cohen@aphp.fr
Hopital Necker Enfants malades
Paris, Île-de-France Region, 75015
Pauline CHASTE, pauline.chaste@aphp.fr
About this study
Self-injuries includes repetitive actions directed at oneself, such as biting, hitting, hitting one's head or limbs, slapping oneself, pulling one's hair, or hitting oneself in the eyes, which can lead to severe injury. They are commonly reported in many neurodevelopmental disorders associated with intellectual development disorders. Faced with the difficulty of treating these self-mutilations, it seems essential to be able to explore new therapeutic avenues. Today, in the rare disease reference centers of the Necker-Enfants malades hospital, neuropathic pain in children, especially those suffering from genetic diseases with skin expression such as primary erythermalgia, is successfully and safely treated with cannabidiol in the event of failure of conventional therapies. It seems essential to be able to confirm the effectiveness of cannabidiol in treating self-injuries in children with neurodevelopmental disorders, and to help understand the mechanisms of action that underlie it. We hypothesize that the nociceptive system is involved in the occurrence of self-injuries and as a target of action of cannabidiol to treat it.
Read the detailed description
The objective of this project is to study the effect of cannabidiol in children with severe neurodevelopmental disorders who engage in significant self-injury, both on the frequency and severity of self-injury and on nonverbal expressions of pain. We expect a positive effect on both of these parameters, as well as a correlation between a reduction in nonverbal expressions of pain and a reduction in the frequency and severity of self-injury. If our expectations are confirmed, this would contribute to expanding the use of cannabidiol, verifying its tolerability in this patient population, and understanding the factors associated with a positive response to this unconventional treatment in order to clarify its indications.
The experimental treatment is the same for all participants. It consists of a cannabidiol (CBD) solution for oral administration: EPIDYOLEX® will be administered orally in two equal doses per day, 12 hours apart, preferably with breakfast and dinner.
- Being tested
- Cannabidiol
- Keywords
- Neurodevelopmental disorders, Cannabidiol, self-injuries, Vineland Adaptive Behaviour II, Behavior Problems Inventory - 01 (BPI-01), Pain Evaluation- Intellectual Disability (GED-DI), Quality of life inventory - Disability (QI-Disability), Parental Stress Scale (PSS), Epidyolex, Non Communicating Children's Pain, Pain evaluation, Parental stress
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidyolex®
EPIDYOLEX® will be administered orally in two equivalent doses taken 12 hours apart each day. It will be started at a dose of 5 mg/kg/day and gradually increased to 25 mg/kg/day over a titration period of 28 days. The target dose of 25 mg/kg/day will be maintained for 35 days.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Multicentre phase II study evaluating the efficacy of CANNABIDIOL (EPIDYOLEX®) in reducing self-injuries and non-verbal expressions of pain in children and adolescents with severe neurodevelopmental disorders. The experimental treatment is the same for all participants will last 63 days. Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of cannabidiol
Efficacy is evaluate by reducing the frequency of self-injuries. Cannabidiol will be considered effective at V8 Day 63 in clinically significant reductions in the frequency of self-injuries if the frequency score on the 'Self-injurious behaviour subdomain of the BPI-01 is reduced by 30% or more at the V8 Day 63 visit compared to the V2 Day 0 visit.
Measured: Day 63
Secondary outcomes (20)
Efficacy of cannabidiol
Cannabidiol will be considered effective at Visit6 Day29 in clinically significant reduction in the frequency of self-injuries if the frequency score in the 'Self-injurious behaviour' sub-domain of the BPI-01 is reduced by 30% or more at the Visit6 Day29 visit compared with the Visit2 Day 0 visit.
Measured: Day 29
Efficacy of cannabidiol / severity of self-injuries
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day29.
For this criteria: severity score in the 'Self-injurious behaviour' sub-domain of BPI-01
Measured: Day 29
Efficacy of cannabidiol / severity of self-injuries
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63.
For this criteria: severity score in the 'Self-injurious behaviour' sub-domain of BPI-01
Measured: Day 63
Efficacy of cannabidiol / severity of Stereotyped behaviour
The efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day0 and visits V6 Day29.
For this criteria: severity score for the BPI-01 sub-domain 'Stereotyped behaviour
Measured: Day 29
Efficacy of cannabidiol / severity of Stereotyped behaviour
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63.
For this criteria: severity score for the BPI-01 sub-domain 'Stereotyped behaviour
Measured: Day 63
Efficacy of cannabidiol / frequency of Stereotyped behaviour
The efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29.
For this criteria: frequency score for the BPI-01 sub-domain 'Stereotyped behaviour
Measured: Day 29
Efficacy of cannabidiol / frequency of Stereotyped behaviour
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63.
For this criteria: frequency score for the BPI-01 sub-domain 'Stereotyped behaviour
Measured: Day 63
Efficacy of cannabidiol / severity of Aggressive/destructive behaviour
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29.
For this criteria: severity score for the BPI-01 sub-domain 'Aggressive/destructive behaviour'
Measured: Day 29
Efficacy of cannabidiol / severity of Aggressive/destructive behaviour
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63.
For this criteria: severity score for the BPI-01 sub-domain 'Aggressive/destructive behaviour'
Measured: Day 63
Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29.
For this criteria: frequency score for the BPI-01 sub-domain 'Aggressive/destructive behaviour'
Measured: Day 29
Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63.
For this criteria: frequency score for the BPI-01 sub-domain 'Aggressive/destructive behaviour'
Measured: Day 63
Efficacy of cannabidiol / the frequency of non-verbal expressions of pain
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29 in GED-DI score
Measured: Day 29
Efficacy of cannabidiol / the frequency of non-verbal expressions of pain
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63 in GED-DI score
Measured: Day 63
Efficacy of cannabidiol / quality of life
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29 in QI-Disability score
Measured: Day 29
Efficacy of cannabidiol / quality of life
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63 in QI-Disability score
Measured: Day 63
Efficacy of cannabidiol / stress related to the child experienced by the parents.
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29 in Parental Stress Scale (PSS) score
Measured: Day 29
Efficacy of cannabidiol / stress related to the child experienced by the parents.
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63 in Parental Stress Scale (PSS) score
Measured: Day 63
Safety of EPIDYOLEX®
serious and non-serious clinical and biological adverse events
Measured: Day 81
Correlation between the evolution of the frequency of self-injuries and the evolution of the frequency of non-verbal expressions of pain
Correlation between the evolution of the frequency of self-injuries (frequency score in the BPI-01 subdomain 'Self-injurious behaviour') and the evolution of the frequency of non-verbal expressions of pain (GED-DI score)
Measured: Day 29
Correlation between the evolution of the frequency of self-injuries and the evolution of the frequency of non-verbal expressions of pain
Correlation between the evolution of the frequency of self-injuries (frequency score in the BPI-01 subdomain 'Self-injurious behaviour') and the evolution of the frequency of non-verbal expressions of pain (GED-DI score)
Measured: Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental Disorders With Severe Self-injuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, Fondation Perce Neige
- Responsible party
- Sponsor
- Investigators
- Pauline CHASTE, MD; PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisMaryse PAGNIER, MD; PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564245
- Sponsor's protocol ID
- APHP240090
- Other IDs
- 2025-521161-27-00, 2025
- Acronym
- CBD-SIB
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders.
- ClinicalTrials.gov ID
- NCT07564245
- Acronym / sponsor ID
- CBD-SIB / APHP240090
- Keywords
- Neurodevelopmental disorders, Cannabidiol, self-injuries, Vineland Adaptive Behaviour II, Behavior Problems Inventory - 01 (BPI-01), Pain Evaluation- Intellectual Disability (GED-DI), Quality of life inventory - Disability (QI-Disability), Parental Stress Scale (PSS), Epidyolex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, Fondation Perce Neige
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 4 May 2026 (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.
Self-injuries includes repetitive actions directed at oneself, such as biting, hitting, hitting one's head or limbs, slapping oneself, pulling one's hair, or hitting oneself in the eyes, which can lead to severe injury. They are commonly reported in many neurodevelopmental disorders associated with intellectual development disorders. Faced with the difficulty of treating these self-mutilations, it seems essential to be able to explore new therapeutic avenues. Today, in the rare disease reference centers of the Necker-Enfants malades hospital, neuropathic pain in children, especially those suffering from genetic diseases with skin expression such as primary erythermalgia, is successfully and safely treated with cannabidiol in the event of failure of conventional therapies. It seems essential to be able to confirm the effectiveness of cannabidiol in treating self-injuries in children with neurodevelopmental disorders, and to help understand the mechanisms of action that underlie it. We hypothesize that the nociceptive system is involved in the occurrence of self-injuries and as a target of action of cannabidiol to treat it.
Detailed description
The objective of this project is to study the effect of cannabidiol in children with severe neurodevelopmental disorders who engage in significant self-injury, both on the frequency and severity of self-injury and on nonverbal expressions of pain. We expect a positive effect on both of these parameters, as well as a correlation between a reduction in nonverbal expressions of pain and a reduction in the frequency and severity of self-injury. If our expectations are confirmed, this would contribute to expanding the use of cannabidiol, verifying its tolerability in this patient population, and understanding the factors associated with a positive response to this unconventional treatment in order to clarify its indications.
The experimental treatment is the same for all participants. It consists of a cannabidiol (CBD) solution for oral administration: EPIDYOLEX® will be administered orally in two equal doses per day, 12 hours apart, preferably with breakfast and dinner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: CannabidiolMulticentre phase II study evaluating the efficacy of CANNABIDIOL (EPIDYOLEX®) in reducing self-injuries and non-verbal expressions of pain in children and adolescents with severe neurodevelopmental disorders. The experimental treatment is the same for all participants will last 63 days. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age between 5 years and 17 years 6 months;
- Weight between 12 and 49.9 kg;
- Clinical diagnosis of severe neurodevelopmental disorder including severe to profound intellectual developmental disorder, characterized in the DSM-5 by a need for help with any daily activity (meals, dressing, toileting, elimination) and the need for constant supervision;
- Severe self-injuries during the last 7 days defined by BPI-01, i.e.:
- Self-injuries refractory to treatment with atypical neuroleptic (RISPERIDONE, ARIPIPRAZOLE, etc.) at a dosage deemed effective by the investigator in view of the patient's weight, age and background, for a minimum duration of 30 days (except in the case of poor tolerance by the patient);
Key exclusion criteria (2 listed)
- 1. Underweight corresponding to a body mass index below the IOTF 18.5 curve on the International Obesity Task Force's body mass index curves for girls and boys 2. Hypersensitivity to the active substance (cannabidiol) or to any of the excipients (refined sesame oil, anhydrous ethanol, sucralose, strawberry flavor, benzyl alcohol); 3. Treatment with or consumption of cannabidiol in the 12 weeks prior to inclusion; 4. Consumption of cannabis in the 12 weeks prior to inclusion; 5. Usual treatment (excluding treatment of self-injuries) containing molecules interacting with cannabidiol (rifampicin, carbamazepine, enzalutamide, mitotane, St. John's wort, clobazam, valproate, stiripentol, phenytoin, lamotrigine, everolimus, theophylline, tizanidine, bupropion, efavirenz, diflunisal, propofol, fenofibrate, gemfibrozil, morphine, lorazepam, repaglinide, warfarin, sirolimus, tacrolimus, digoxin); 6. Elevated transaminases > 3N or total bilirubin > 2N; 7. Known current heart failure; 8. Known current terminal renal failure (GFR < 15 ml/min/1.73 m2); 9. Known current moderate or severe hepatic insufficiency (Child-Pugh B or C); 10. Known current epilepsy or history of epilepsy, even stabilized, requiring treatment currently or not, whatever the type; 11. Pregnancy or breastfeeding; 12. Inability of the patient or entourage to comply with the study protocol; 13. Patient currently participating in another interventional research (category 1 or 2), clinical trial or clinical investigation, or who are in the exclusion period following him/her participation in another study of this type, as defined in the protocol of that study.
- 14. Participant related to a person involved in the study at the investigational site
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 |
|---|---|---|
| CannabidiolAlso: Epidyolex®EPIDYOLEX® will be administered orally in two equivalent doses taken 12 hours apart each day. It will be started at a dose of 5 mg/kg/day and gradually increased to 25 mg/kg/day over a titration period of 28 days. The target dose of 25 mg/kg/day will be maintained for 35 days. | Drug | Cannabidiol |
Primary outcome
Efficacy of cannabidiol
Time frame: Day 63
Efficacy is evaluate by reducing the frequency of self-injuries. Cannabidiol will be considered effective at V8 Day 63 in clinically significant reductions in the frequency of self-injuries if the frequency score on the 'Self-injurious behaviour subdomain of the BPI-01 is reduced by 30% or more at the V8 Day 63 visit compared to the V2 Day 0 visit.
20 secondary outcomes
Efficacy of cannabidiol
Time frame: Day 29
Efficacy of cannabidiol / severity of self-injuries
Time frame: Day 29
Efficacy of cannabidiol / severity of self-injuries
Time frame: Day 63
Efficacy of cannabidiol / severity of Stereotyped behaviour
Time frame: Day 29
Efficacy of cannabidiol / severity of Stereotyped behaviour
Time frame: Day 63
Efficacy of cannabidiol / frequency of Stereotyped behaviour
Time frame: Day 29
Efficacy of cannabidiol / frequency of Stereotyped behaviour
Time frame: Day 63
Efficacy of cannabidiol / severity of Aggressive/destructive behaviour
Time frame: Day 29
Efficacy of cannabidiol / severity of Aggressive/destructive behaviour
Time frame: Day 63
Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour
Time frame: Day 29
Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour
Time frame: Day 63
Efficacy of cannabidiol / the frequency of non-verbal expressions of pain
Time frame: Day 29
Efficacy of cannabidiol / the frequency of non-verbal expressions of pain
Time frame: Day 63
Efficacy of cannabidiol / quality of life
Time frame: Day 29
Efficacy of cannabidiol / quality of life
Time frame: Day 63
Efficacy of cannabidiol / stress related to the child experienced by the parents.
Time frame: Day 29
Efficacy of cannabidiol / stress related to the child experienced by the parents.
Time frame: Day 63
Safety of EPIDYOLEX®
Time frame: Day 81
Correlation between the evolution of the frequency of self-injuries and the evolution of the frequency of non-verbal expressions of pain
Time frame: Day 29
Correlation between the evolution of the frequency of self-injuries and the evolution of the frequency of non-verbal expressions of pain
Time frame: Day 63
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 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Neurodevelopmental Disorders With Severe Self-injuries
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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.
Pauline CHASTE, MD; PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Maryse PAGNIER, MD; PhD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Neurodevelopmental Disorders With Severe Self-injuries, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 12 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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?
Contact Pauline CHASTE, MD; PhD (01 44 49 57 59, pauline.chaste@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of cannabidiol (time frame: Day 63). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.