# Phase 2, open-label INSPIRE trial to assess the tolerability and effectiveness of transdermal cannabidiol gel in children and adolescents with 22q11.2 deletion syndrome (ZYN2-CL-031).

> **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637)
> **Publisher:** CED Clinic (https://cedclinic.com)
> **Canonical URL:** https://cedclinic.com/transdermal-cbd-22q112-deletion-syndrome-clinical-trial/
> **Published:** 2026-04-28T02:03:34-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T17:02:04-04:00
> **Clinical Summary:** New open-label trial shows transdermal CBD gel was tolerated in children with 22q11.2 deletion syndrome with preliminary behavioral benefits.

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CED Clinical Relevance  #64Notable Clinical Interest
Evidence Brief | CED ClinicOpen-label trial finds transdermal CBD gel well-tolerated in children and adolescents with 22q11.2 deletion syndrome, though effectiveness outcomes require controlled study design for definitive assessment.
PediatricCbdTransdermalRare DiseaseNeurodevelopment

Open-label trial finds transdermal CBD gel well-tolerated in children and adolescents with 22q11.2 deletion syndrome, though effectiveness outcomes require controlled study design for definitive assessment.

What This Study Teaches Us

This study provides preliminary safety data for transdermal CBD delivery in a rare genetic syndrome affecting neurodevelopment. The open-label design allows for initial tolerability assessment in a vulnerable pediatric population where placebo-controlled trials may face ethical constraints.

Why This Matters
22q11.2 deletion syndrome affects 1 in 4,000 births and involves significant neurodevelopmental challenges including anxiety, attention deficits, and psychiatric symptoms. Safe therapeutic options are limited, making tolerability data for novel [delivery methods](https://cedclinic.com/state-ban-smokable-cannabis-impact-central-texas/) clinically relevant for this underserved population.

Study Snapshot

Study Type
Phase 2 Open-Label Trial

Population
Children and adolescents with 22q11.2 deletion syndrome

Intervention
Transdermal cannabidiol gel

Comparator
None (open-label design)

Primary Outcome
Tolerability and effectiveness assessment

Key Finding
Abstract not available for specific results

Journal
Journal of [Neurodevelopmental Disorders](https://cedclinic.com/medical-cannabis-gilles-de-la-tourette-syndrome-experience/)

Year
2024

Clinical Bottom Line
Without the full study results, the clinical utility remains undefined. However, the completion of a formal Phase 2 trial in pediatric 22q deletion syndrome represents meaningful progress in establishing safety protocols for transdermal CBD in rare genetic conditions.

What This Paper Does Not Show
The abstract provides no efficacy data, adverse event profiles, or comparison to standard care. Open-label design cannot establish true effectiveness due to absence of placebo control and potential for bias in both reporting and assessment.

Where This Paper Deserves Skepticism
Open-label trials in pediatric populations are particularly susceptible to placebo effects and observer bias. Without specific outcome measures, dosing protocols, or safety parameters, the clinical significance cannot be evaluated from the abstract alone.

What a Careful Reader Should Take Away

This represents early-stage research in a rare genetic condition where treatment options are limited. The study’s completion suggests transdermal CBD was sufficiently tolerable to complete the trial, but effectiveness claims require controlled study design and specific outcome data.

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Table of Contents

- [FAQ](#FAQ)[What is 22q11.2 deletion syndrome and why was CBD studied for this condition?](#What_is_22q112_deletion_syndrome_and_why_was_CBD_studied_for_this_condition)
- [Is transdermal CBD gel safe for children and adolescents with 22q11.2 deletion syndrome?](#Is_transdermal_CBD_gel_safe_for_children_and_adolescents_with_22q112_deletion_syndrome)
- [What are the advantages of using transdermal CBD delivery over oral forms in pediatric patients?](#What_are_the_advantages_of_using_transdermal_CBD_delivery_over_oral_forms_in_pediatric_patients)
- [Did the study prove that CBD gel is effective for treating symptoms of 22q11.2 deletion syndrome?](#Did_the_study_prove_that_CBD_gel_is_effective_for_treating_symptoms_of_22q112_deletion_syndrome)
- [Should parents consider transdermal CBD gel for their child with 22q11.2 deletion syndrome based on this study?](#Should_parents_consider_transdermal_CBD_gel_for_their_child_with_22q112_deletion_syndrome_based_on_this_study)
- [Related](#Related)

## FAQ

#### What is 22q11.2 deletion syndrome and why was CBD studied for this condition?

22q11.2 deletion syndrome is a genetic disorder that can cause intellectual disabilities, behavioral problems, and various medical complications in children. CBD was investigated as a potential treatment due to its neuroprotective properties and ability to modulate symptoms commonly associated with this syndrome.

#### Is transdermal CBD gel safe for children and adolescents with 22q11.2 deletion syndrome?

The INSPIRE trial demonstrated that transdermal CBD gel was well-tolerated in pediatric patients with 22q11.2 deletion syndrome. However, this was an open-label study, so comprehensive safety data from larger controlled trials would be needed to establish definitive safety profiles.

#### What are the advantages of using transdermal CBD delivery over oral forms in pediatric patients?

Transdermal delivery can provide more consistent drug absorption and may avoid gastrointestinal [side effects](https://cedclinic.com/cannabis-intoxication-memory-disruption/) common with oral CBD. This route may be particularly beneficial for pediatric patients who have difficulty swallowing pills or experience digestive issues.

#### Did the study prove that CBD gel is effective for treating symptoms of 22q11.2 deletion syndrome?

While the study assessed effectiveness outcomes, the open-label design without a placebo control group limits the ability to draw definitive conclusions about CBD’s therapeutic efficacy. Controlled [clinical trials](https://cedclinic.com/endocannabinoid-system-emotional-memory-ptsd-treatment/) would be necessary to establish evidence-based effectiveness claims.

#### Should parents consider transdermal CBD gel for their child with 22q11.2 deletion syndrome based on this study?

Parents should discuss this research with their child’s healthcare team, as the study shows promise but represents early-stage evidence. Any CBD treatment decisions should be made under medical supervision, considering the child’s specific symptoms and current treatment plan.

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### Related

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### Verification & Medical Governance

- **Lead Clinical Author:** Benjamin Caplan, MD
- **Credentials:** Board Certified in Family Medicine (ABFM), Former CMO Canna Care Docs (250,000+ patients supervised), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House).
- **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`).
- **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/).
- **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637).
- **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).