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ZYN002 for Deletion Syndrome (INSPIRE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Zynerba Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse event time frame is from admission to a study completion, an average of 9 months
Awards & highlights

INSPIRE Trial Summary

This trial is testing a new drug for 22qDS that is applied as a gel. It will last up to 38 weeks to see how safe and well-tolerated it is for patients 4-18 years old.

Eligible Conditions
  • Deletion Syndrome

INSPIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse event time frame is from admission to a study completion, an average of 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse event time frame is from admission to a study completion, an average of 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (safety and tolerability)
Secondary outcome measures
Aberrant Behavior Checklist (ABC-C) Pre-specified Subscale 1
Anxiety, Depression and Mood Scale (ADAMS)
Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I)
+2 more

Side effects data

From 2015 Phase 3 trial • 120 Patients • NCT02091375
31%
Diarrhoea
31%
Somnolence
26%
Decreased appetite
18%
Fatigue
15%
Vomiting
15%
Pyrexia
11%
Upper respiratory tract infection
11%
Lethargy
8%
Convulsion
7%
Weight decreased
7%
Gamma-glutamyltransferase increased
7%
Irritability
7%
Cough
7%
Transaminases increased
5%
Status epilepticus
5%
Nasopharyngitis
2%
Pneumonia
2%
Oral herpes
2%
Platelet count
2%
Abdominal distension
2%
Abdominal pain
2%
Gastrointestinal haemorrhage
2%
Asthenia
2%
Lower respiratory tract infection
2%
Gamma-glutamyltransferase
2%
Hypophagia
2%
Hypotonia
2%
Myoclonus
2%
Respiratory failure
2%
Epistaxis
2%
Hypovolaemic shock
2%
Aspartate aminotransferase increased
2%
Liver function test abnormal
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GWP42003-P 20 mg/kg/Day Dose

INSPIRE Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
Open-label
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZYN002
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Zynerba Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
866 Total Patients Enrolled
Carol O'NeillStudy DirectorVP, Development

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome
2020. "Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05149898.
~4 spots leftby Apr 2025
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