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Cannabidiol for Seizures

Phase 3
Recruiting
Research Sponsored by GW Research Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have uncontrolled seizures, and who are currently receiving 1 or more antiseizure medication (ASMs)
Participants with TSC must have a diagnosis per the 2012 International Tuberous Sclerosis Complex Consensus Conference
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 3 hours and 6 hours post dose on days 1, 15, 29, 57, and end of treatment (week 52)
Awards & highlights

Study Summary

This trial will study a new seizure medication to see if it is safe and effective.

Who is the study for?
This trial is for children under 2 years old with TSC, LGS, or DS who have seizures not well-controlled by current medications. They must be diagnosed according to specific guidelines and their caregivers should consent and comply with study requirements. Children with certain health issues or hypersensitivity to cannabinoids are excluded.Check my eligibility
What is being tested?
The trial tests GWP42003-P, a cannabidiol oral solution as an additional treatment for young children with TSC, LGS, or DS experiencing poorly controlled seizures. It aims to assess the safety, how the body processes the drug (pharmacokinetics), and its effectiveness.See study design
What are the potential side effects?
Potential side effects of GWP42003-P may include sleepiness, decreased appetite, diarrhea, fever, vomiting and fatigue. Since it contains cannabidiol derived from cannabis plants there might also be risks related to mood changes or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have seizures that aren't controlled even though I'm on medication.
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I have been diagnosed with Tuberous Sclerosis Complex according to the 2012 guidelines.
Select...
My seizures are not fully controlled by my current medication.
Select...
My epilepsy diagnosis aligns with international guidelines and has been confirmed by a specialist group.
Select...
My child is between 1 month and 2 years old and has TSC, DS, or LGS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 3 hours and 6 hours post dose on days 1, 15, 29, 57, and end of treatment (week 52)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 3 hours and 6 hours post dose on days 1, 15, 29, 57, and end of treatment (week 52) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change From Baseline in Blood Pressure
Mean Change From Baseline in Body Weight
Mean Change From Baseline in Heart Rate
+14 more
Secondary outcome measures
Number of Participants Who Achieved Seizure-Free Status
Number of Treatment Responders
Percentage Change from Baseline in Total Countable Seizures
+1 more

Side effects data

From 2016 Phase 3 trial • 225 Patients • NCT02224560
21%
Somnolence
16%
Upper respiratory tract infection
16%
Decreased appetite
10%
Status epilepticus
10%
Diarrhoea
9%
Pyrexia
9%
Irritability
7%
Fatigue
6%
Insomnia
6%
Vomiting
4%
Lethargy
4%
Nasopharyngitis
4%
Pneumonia
3%
Headache
3%
Convulsion
1%
Pancreatitis
1%
Transaminases increased
1%
Sedation
1%
Dehydration
1%
Aspartate aminotransferase increased
1%
Hypoventilation
1%
Sleep apnoea syndrome
1%
Cholecystitis chronic
1%
Pneumonia bacterial
1%
Pneumonia respiratory syncytial viral
1%
Hypoxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo-Safety Analysis Set
GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set
GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set

Trial Design

1Treatment groups
Experimental Treatment
Group I: GWP42003-PExperimental Treatment1 Intervention
The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization. Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.)) Day 8: 10 mg/kg/day (5 mg/kg b.i.d.) Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GWP42003-P
2016
Completed Phase 3
~1740

Find a Location

Who is running the clinical trial?

GW Research LtdLead Sponsor
34 Previous Clinical Trials
3,181 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,332 Total Patients Enrolled

Media Library

GWP42003-P Clinical Trial Eligibility Overview. Trial Name: NCT04485104 — Phase 3
Tuberous Sclerosis Complex Research Study Groups: GWP42003-P
Tuberous Sclerosis Complex Clinical Trial 2023: GWP42003-P Highlights & Side Effects. Trial Name: NCT04485104 — Phase 3
GWP42003-P 2023 Treatment Timeline for Medical Study. Trial Name: NCT04485104 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we enrolling participants for this experiment at this time?

"Yes, this study is still looking for participants and was originally posted on May 19th, 2021. The most recent update to the study was made on July 6th, 2022."

Answered by AI

Could you tell me if patients who are younger than 30 can join this particular research project?

"Eligibility for this clinical study starts at 1 month old and caps at 11 months old."

Answered by AI

What is the scientific consensus on the efficacy of SOC?

"The first study of SOC occurred in 2012 at Davidof Cancer Center. As of now, there have been 131 completed studies with 83 active trials. A large majority of these active trials are happening in Little Rock, Arkansas."

Answered by AI

Does this research project have any inclusion or exclusion criteria?

"This clinical trial is looking for 12 participants who currently have sclerosis and are between the ages of 1 month and 11 months. Additionally, participants must meet the following criteria:- Must be 1 month to < 12 months of age at the time of initial informed consent- Parent(s)/legal representative is/are willing and able to give informed consent for participation in the trial.- Parent(s)/legal representative is/are willing and able (in the investigator's opinion) to comply with all trial requirements (including accurate electronic participant-reported outcome [ePRO] diary completion).- Must have a clinical diagnosis"

Answered by AI

What does the FDA's stance on SOC look like?

"SOC has been studied in Phase 3 trials, so there is some evidence to support both its efficacy and safety."

Answered by AI
~6 spots leftby Jan 2025