CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
ZYN002drug
Likely dose
ZYN002 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05149898
NCT05149898Phase 2Completed
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An Open-Label Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome

Harmony Biosciences Management, Inc.·interventional·Posted Dec 8, 2021·Updated Mar 9, 2026

In Brief

A Phase 2 clinical trial evaluating ZYN002 for 22Q11.2 Deletion Syndrome. Completed, enrolled 20 participants across 3 sites in 2 countries.

Detailed Summary

To evaluate the safety and tolerability of ZYN002 administered as a transdermal gel formulation, for up to 38 weeks, in participants ages 4 to \<18 years, in the treatment of 22q.11.2 Deletion syndrome (22qDS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Conditions22Q11.2 Deletion Syndrome
CountriesAustralia, United States
CollaboratorsZynerba Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 8, 2021
Enrollment StartFeb 19, 2020
Primary CompletionNov 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.6 years ago

Interventions

ZYN002drug

Synthetic CBD (sCBD) Transdermal Gel pharmaceutically manufactured. sCBD formulated as a clear gel (transdermal delivery). Dose received is based on weight. 1. Participants who weigh ≤ 35 kilogram (kg) will receive 125 mg CBD Q12H (every 12 hours ± 2 hours); for a total daily dose of 250 mg CBD. 2. Participants who weigh \> 35 kg will receive 250 mg CBD Q12H (±2 hours) for a total daily dose of 500 mg CBD. Patients in both weight ranges ≤ 35 kg or \> 35 kg may receive an increased daily dose of 500 mg sCBDor 750 mg sCBD, respectively.