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A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE

ConditionDevelopmental and Epileptic Encephalopathy (DEE)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorJazz Pharmaceuticals

About this trial

The efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is at least 1 year of age at the time of signing the informed consent/assent.

Meets the clinical phenotype for DEE as specified in the protocol.

Per the investigator, the underlying etiology contributes to developmental impairment and seizures.

Has had, or is willing to complete, confirmatory imaging and/or genetic testing to determine etiology of DEE.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • CBD-OS

    Drug

    Oral solution, twice daily

  • Placebo

    Drug

    Oral solution, twice daily

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: CBD-OSExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Open-Label Extension: CBD-OSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Countable Motor Seizure Frequency Per 28 Days

Time frame
Baseline up to 6 weeks of double-blind treatment period

Secondary outcomes

1

Change in Total Seizure Frequency Per 28 Days

Time frame
Baseline up to 6 weeks of double-blind treatment period
2

Proportion of Participants Who Achieve ≥ 50% Reduction From Baseline in Countable Motor Seizure Frequency

Time frame
Baseline up to 6 weeks of double-blind treatment period
3

Caregiver Global Impression of Change (CaGI-C) Score

Time frame
Week 6 of double-blind treatment period
4

Change from Baseline in Caregiver Global Impression of Severity (CaGI-S) Score

Time frame
Week 6 of double-blind treatment period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jazz Pharmaceuticals

Lead sponsor

Jazz Pharmaceuticals Research UK Limited

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: