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A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS

ConditionLennox-Gastaut Syndrome
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals

About this trial

This is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a confirmed clinical diagnosis of LGS with a history of seizures and actively experiencing seizures within 6 months of screening.

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 (eg, alcohol consumption, smoking, concomitant medication usage) stable for the duration of the study.

Is currently treated with at least 1 ASM, but no more than 3 ASMs, and is on a stable regimen for at least 4 weeks prior to screening.

Disqualifiers

Has a significant psychiatric illness

Has an illness during the 4 weeks prior to screening other than epilepsy which, in the investigator's opinion, could affect study outcomes or seizure frequency.

Has history of SE in the 3 months prior to screening.

Has any other significant disease other than epilepsy, which, in the investigator's opinion, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cannabidiol Oral Solution

    Drug

    100 mg/ml Cannabidiol Oral solution (CBD-OS)

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Cannabidiol Oral Solution Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants reporting 50% or more reduction in their 28-day average countable major motor seizure frequency

Time frame
End of Treatment Period, Week 24

Secondary outcomes

1

Retention Rate

Retention Rate is defined as percentage of participants completing or continuing CBD-OS treatment at different timepoints in the study

Time frame
At Weeks 8, 12, 16 and 24
2

Percentage of participants experiencing worsening, change, no change or improvement in in their 28-day average countable major motor and total seizure frequency

As reported in participants' electronic diaries

Time frame
Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24
3

Percentage of participants considered treatment responders

Treatment responders will be categorized as those experiencing a 50% or more reduction, a 75% or more reduction or 100% reduction in their 28-day average seizure frequency as reported in participants' electronic diaries

Time frame
Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24
4

Change in 28-day average frequency of countable major motor and total seizures

Assessed per 28 days from electronic diary entries

Time frame
Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

Other outcomes

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: