Tuberous Sclerosis Complex Associated Neuropsychiatric DiseasePhase 4EpiComNCT05864846
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex
A Phase 4 study testing Cannabidiol Oral Solution [Epidiolex] in people with Tuberous Sclerosis Complex Associated Neuropsychiatric Disease, run by Jazz Pharmaceuticals at 19 sites in 4 countries.
Trial summary
The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Tuberous Sclerosis Complex Associated Neuropsychiatric Disease
- What is being tested?
- Cannabidiol Oral Solution [Epidiolex]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 29 Jun 2023to 6 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is within the required age range at the time of signing (or at the time of the participant's parent(s)/Legally Authorized Representative (LAR) signing) the informed consent or providing assent (as applicable):
- Participants based in the US: 1 to 65 years of age, inclusive.
- Participants based outside the US: 2 to 65 years of age, inclusive.
- Has a confirmed clinical diagnosis of TSC with a history of seizures in accordance with the 2012 International Tuberous Sclerosis Complex Consensus Conference criteria.
- Has behaviors (eg, aggression, impulsivity, temper tantrum, self-injury, hyperactivity, extreme shyness, mood swings, poor eye contact, repetitive behaviors, restlessness, difficulty getting along with peers, rigid/inflexible to procedure and/or change) that are considered moderate or severe per the CareGI-S at Screening.
- Is taking 1 or more anti-seizure medicine (ASM) at a dose that has been stable for at least 4 weeks prior to Screening.
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- All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for 4 weeks prior to screening and any major changes to treatment regimens should be discussed with the medical monitor.
- Is naïve to CBD-OS treatment or has been off CBD-OS treatment for at least 3 months prior to Screening.
- Is willing to maintain any factors expected to affect seizures stable (eg, alcohol consumption, smoking, concomitant medication usage).
- Is male or female
- Male participants:
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 weeks, corresponding to the time needed to eliminate the study intervention after the last dose of study intervention:
- Refrain from donating fresh unwashed semen. PLUS
- Use a male condom in addition to a second method of acceptable contraception used by their female partners when having sexual intercourse with a women of childbearing potential (WOCBP) who is not currently pregnant.
- Female participants:
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Is a woman of nonchildbearing potential. OR
- Is a WOCBP and using a contraceptive method that is highly effective, preferably with low user dependency during the study intervention period and for at least 3 months after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy test within 28 days before the first dose of study intervention.
Who cannot join
- Has a clinically significant unstable medical condition other than epilepsy.
- Has an illness during the 4 weeks prior to screening other than epilepsy which, in the investigator's opinion, could affect study outcomes.
- Has TSC-specific tumor growth which, in the investigator's opinion, could affect the effectiveness endpoints.
- Has previously undergone significant surgery for epilepsy that, in the investigator's opinion, may impact the assessment of outcomes.
- Has initiated felbamate within the last 12 months prior to Screening.
- Is currently using or has in the past used recreational or medicinal cannabis or synthetic cannabinoid-based medications within the 3 months prior to Screening and is not willing to undergo a 1-month washout period before being rescreened.
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- Has received an investigational medicinal product within the 3 months prior to the Screening Visit.
- Has previously been assigned study intervention for this study or is currently enrolled in any other interventional study.
- Has laboratory values at the Baseline Visit that are abnormal and of clinical significance in the investigator's opinion.
- Participant has significantly impaired hepatic function at the Baseline Visit.
- Has any history of suicidal behavior or any suicidal ideation of type 4 or 5 as evaluated with C-SSRS or Children's C-SSRS at the Screening Visit (for participants ≥ 4 years of age).
- Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of CBD-OS.
- Has a known or suspected history of alcohol or substance abuse.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States12 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia, Charlottesville
Charlottesville, Virginia, 22903
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Florida Health - Department of Neurology
Gainesville, Florida, 32608
University of Texas Health Science Center at Houston - Clinical Research Unit
Houston, Texas, 77030
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Nicklaus Children's Health, Miami
Miami, Florida, 33155
Yale University School of Medicine
New Haven, Connecticut, 06519
Minnesota Epilepsy Group
Roseville, Minnesota, 55113
University of Texas Health Science Center - San Antonio
San Antonio, Texas, 78229
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Canada3 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6AB
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
United Kingdom3 sites
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 3NU
Evelina London Children's Hospital Guys St Thomas' NHS Foundation Trust, the Guy's Hospital
London, England, SE1 7EH
Sheffield Children's NHS Foundation Trust
Sheffield, 2TH
About this study
Official title: A Phase 4, Interventional, Multicenter, Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuberous Sclerosis Complex
The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
- Being tested
- Cannabidiol Oral Solution [Epidiolex]
- Keywords
- Seizures, Tuberous Sclerosis Complex (TSC), Tuberous Sclerosis Complex Associated Neuropsychiatric Disorders (TAND), Epidiolex, Epidyolex, GWP42003-P, JZP926, TSC Associated Neuropsychiatric Disorders, Cannabidiol, Behavior
- Medical subject headings
- Seizures, Tuberous Sclerosis, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol Oral Solution [Epidiolex]Drug
Also called Epidiolex
100 mg/ml Cannabidiol Oral solution
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol Oral Solution | Experimental | Participants who will receive the Cannabidiol Oral Solution (CBD-OS) titrated up to a dose of 12.5 mg/kg administered twice daily for a total dose of up to 25 mg/kg/day for 26 consecutive weeks. Participants will have the option to continue receiving the CBD-OS for an additional 26 weeks, for a total of 52 weeks. Receives: Drug: Cannabidiol Oral Solution [Epidiolex] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the most problematic behavior Numerical Rating Score (NRS) score within the TAND-SQ
Measured: Baseline, Week 13, Week 26, Week 52
Change in Tuberous Sclerosis Complex Associated Neuropsychiatric Disorders Self-report, Quantified Checklist (TAND-SQ) score
Measured: Baseline, Week 13, Week 26, Week 52
Change in Aberrant Behavior Checklist (ABC) score
Measured: Baseline, Week 13, Week 26, Week 52
Change in Child Behavior Checklist (CBCL) score
Measured: Baseline, Week 26, Week 52
Change in Adult Behavior Checklist (ABCL) score
Measured: Baseline, Week 26, Week 52
Change in Adult Self-Report (ASR) score
Measured: Baseline, Week 26, Week 52
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) domains score
Measured: Baseline, Week 26, Week 52
Change in sleep characteristics using the Children's Sleep Habits Questionnaire (CSHQ)
Measured: Baseline, Week 26
Change in sleep characteristics using the Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline, Week 26
Change in executive function using Behavior Rating Inventory of Executive Function (BRIEF)
Measured: Baseline, Week 26
Change in caregiver-reported assessment of Quality of Life (QOL) using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Measured: Baseline, Week 26
Change in caregiver-reported assessment of family functioning using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Measured: Baseline, Week 26
Change in assessment of QOL using Pediatric Quality of Life Inventory (PedsQL)
Measured: Baseline, Week 26
Change in caregiver impression of overall severity of symptoms (behavior and seizure control) using the Caregiver Global Impression of Severity (CareGI-S)
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Change in participant impression of overall severity of symptoms (behavior and seizure control) using the Patient Global Impression of Severity (PGI-S)
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Change in clinician impression of overall severity of symptoms (behavior and seizure control) using the Clinician Global Impression of Severity (CGI-S)
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Retention Rate
Retention rate is the number of participants continuing with CBD-OS treatment over total accrued participants
Measured: Baseline, Week 13, Week 26, Week 52
Number of participants considered treatment responders
Treatment responders will be reported as those with a 25%, 50%, 75% and 100% reduction in seizure frequency from baseline
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of seizure-free days
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participants experiencing a worsening, no change, or improvement in seizure frequency
Number of participants who experience a change in seizure frequency from baseline defined as:
- worsening (>25%)
- no change (-25 to + 25%)
- improvement (-25% to -50%, ≥-50% to -75%, ≥-75%)
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Change in ideation score per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the C-SSRS
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Change in ideation score per the Children's C-SSRS
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the Children's C-SSRS
Measured: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participant inpatient hospitalizations due to epilepsy
Measured: Up to Week 52
Number of withdrawals due to Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start29 Jun 2023
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
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 Tuberous Sclerosis Complex Associated Neuropsychiatric DiseaseStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864846
- Sponsor's protocol ID
- JZP926-402
- Other IDs
- 2023-507426-17, 2023
- Acronym
- EpiCom
- Status last verified
- Apr 2026
- First submitted
- 9 May 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy, contact clinicaldatasharing@jazzpharma.com
Publications
Moore-Ramdin L, van Eeghen A, Stevens J, Takhar P, Meitzler S, Fladrowski C, Rozenberg M, Amin S. Co-Creation of the EpiCom Clinical Trial: Bringing the Tuberous Sclerosis Complex Patient Community, Healthcare Professionals, and the Pharmaceutical Industry Together. Patient. 2026 Jul 11. doi: 10.1007/s40271-026-00830-5. Online ahead of print.
PubMed 42435131
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Interventional, Multicenter, Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuberous Sclerosis Complex
- ClinicalTrials.gov ID
- NCT05864846
- Acronym / sponsor ID
- EpiCom / JZP926-402
- Keywords
- Seizures, Tuberous Sclerosis Complex (TSC), Tuberous Sclerosis Complex Associated Neuropsychiatric Disorders (TAND), Epidiolex, Epidyolex, GWP42003-P, JZP926, TSC Associated Neuropsychiatric Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 18 May 2023 (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.
The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol Oral Solution | Experimental | Drug: Cannabidiol Oral Solution [Epidiolex]Participants who will receive the Cannabidiol Oral Solution (CBD-OS) titrated up to a dose of 12.5 mg/kg administered twice daily for a total dose of up to 25 mg/kg/day for 26 consecutive weeks. Participants will have the option to continue receiving the CBD-OS for an additional 26 weeks, for a total of 52 weeks. |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Is within the required age range at the time of signing (or at the time of the participant's parent(s)/Legally Authorized Representative (LAR) signing) the informed consent or providing assent (as applicable):
- Has a confirmed clinical diagnosis of TSC with a history of seizures in accordance with the 2012 International Tuberous Sclerosis Complex Consensus Conference criteria.
- Has behaviors (eg, aggression, impulsivity, temper tantrum, self-injury, hyperactivity, extreme shyness, mood swings, poor eye contact, repetitive behaviors, restlessness, difficulty getting along with peers, rigid/inflexible to procedure and/or change) that are considered moderate or severe per the CareGI-S at Screening.
- Is taking 1 or more anti-seizure medicine (ASM) at a dose that has been stable for at least 4 weeks prior to Screening.
- Is naïve to CBD-OS treatment or has been off CBD-OS treatment for at least 3 months prior to Screening.
Key exclusion criteria (13 listed)
- Has a clinically significant unstable medical condition other than epilepsy.
- Has an illness during the 4 weeks prior to screening other than epilepsy which, in the investigator's opinion, could affect study outcomes.
- Has TSC-specific tumor growth which, in the investigator's opinion, could affect the effectiveness endpoints.
- Has previously undergone significant surgery for epilepsy that, in the investigator's opinion, may impact the assessment of outcomes.
- Has initiated felbamate within the last 12 months prior to Screening.
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 |
|---|---|---|
| Cannabidiol Oral Solution [Epidiolex]Also: Epidiolex100 mg/ml Cannabidiol Oral solution | Drug | Cannabidiol Oral Solution |
Primary outcome
Change in the most problematic behavior Numerical Rating Score (NRS) score within the TAND-SQ
Time frame: Baseline, Week 13, Week 26, Week 52
Change in Tuberous Sclerosis Complex Associated Neuropsychiatric Disorders Self-report, Quantified Checklist (TAND-SQ) score
Time frame: Baseline, Week 13, Week 26, Week 52
Change in Aberrant Behavior Checklist (ABC) score
Time frame: Baseline, Week 13, Week 26, Week 52
Change in Child Behavior Checklist (CBCL) score
Time frame: Baseline, Week 26, Week 52
Change in Adult Behavior Checklist (ABCL) score
Time frame: Baseline, Week 26, Week 52
Change in Adult Self-Report (ASR) score
Time frame: Baseline, Week 26, Week 52
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) domains score
Time frame: Baseline, Week 26, Week 52
Change in sleep characteristics using the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, Week 26
Change in sleep characteristics using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 26
Change in executive function using Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline, Week 26
Change in caregiver-reported assessment of Quality of Life (QOL) using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Time frame: Baseline, Week 26
Change in caregiver-reported assessment of family functioning using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Time frame: Baseline, Week 26
Change in assessment of QOL using Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline, Week 26
Change in caregiver impression of overall severity of symptoms (behavior and seizure control) using the Caregiver Global Impression of Severity (CareGI-S)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in participant impression of overall severity of symptoms (behavior and seizure control) using the Patient Global Impression of Severity (PGI-S)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in clinician impression of overall severity of symptoms (behavior and seizure control) using the Clinician Global Impression of Severity (CGI-S)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Retention Rate
Time frame: Baseline, Week 13, Week 26, Week 52
Retention rate is the number of participants continuing with CBD-OS treatment over total accrued participants
Number of participants considered treatment responders
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Treatment responders will be reported as those with a 25%, 50%, 75% and 100% reduction in seizure frequency from baseline
Change in number of seizure-free days
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participants experiencing a worsening, no change, or improvement in seizure frequency
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participants who experience a change in seizure frequency from baseline defined as: 1. worsening (>25%) 2. no change (-25 to + 25%) 3. improvement (-25% to -50%, ≥-50% to -75%, ≥-75%)
Change in ideation score per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the C-SSRS
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in ideation score per the Children's C-SSRS
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the Children's C-SSRS
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participant inpatient hospitalizations due to epilepsy
Time frame: Up to Week 52
Number of withdrawals due to Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42435131Moore-Ramdin L, van Eeghen A, Stevens J, Takhar P, Meitzler S, Fladrowski C, Rozenberg M, Amin S. Co-Creation of the EpiCom Clinical Trial: Bringing the Tuberous Sclerosis Complex Patient Community, Healthcare Professionals, and the Pharmaceutical Industry Together. Patient. 2026 Jul 11. doi: 10.1007/s40271-026-00830-5. Online ahead of print.
- Individual participant dataSharing planned: Yes. In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy, contact clinicaldatasharing@jazzpharma.com
Related trials for Tuberous Sclerosis Complex Associated Neuropsychiatric Disease
Recruiting
Regulating Together in Tuberous Sclerosis Complex
TSC, Behavioral Symptoms
Enrolling by invitation
TANDem-2: Closing the Gap to Interventions for TAND
Adult Caregivers of Individuals With TSC, Tuberous Sclerosis Complex (TSC)
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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cannabidiol Oral Solution [Epidiolex] in people with Tuberous Sclerosis Complex Associated Neuropsychiatric Disease, run by Jazz Pharmaceuticals at 19 sites in 4 countries.
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 19 inclusion and 13 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: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, United Kingdom, Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the most problematic behavior Numerical Rating Score (NRS) score within the TAND-SQ (time frame: Baseline, Week 13, Week 26, Week 52). The study lists 26 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 NCT05864846, 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 27 Apr 2026.