← Back to Search

GWP42003-P for Epilepsy

Phase 3
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 14, 24, and 48
Awards & highlights

Study Summary

This trialwill assess a new epilepsy drug's effectiveness and safety in children with myoclonic-atonic seizures. Part A will assess efficacy & tolerability, Part B will assess long-term safety.

Eligible Conditions
  • Epilepsy-Associated Seizures (EMAS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 14, 24, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 14, 24, and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Percent change from Baseline in epilepsy with myoclonic-atonic seizures (EMAS) associated seizure frequency (myoclonic-atonic, atonic, tonic, clonic, or tonic-clonic) over the 14-week treatment period
Part B: Number of participants with a change in Columbia-Suicide Severity Rating Scale (C-SSRS) ideation scores
Part B: Number of participants with a change in the number of suicide attempts per C-SSRS scores
+6 more
Secondary outcome measures
Part A: Caregiver Global Impression of Change (CGIC) score at Week 14
Part A: Change from Baseline in the number of EMAS-associated seizure-free days over the 14-week treatment period
Part A: Number of participants who achieve ≥ 25%, ≥ 50%, ≥ 75%, and 100% reduction from Baseline in total seizures over the 14-week treatment period
+21 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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GWP42003-PExperimental Treatment1 Intervention
Participants will be initiated on a dose of GWP42003-P 2.5 milligrams per kilogram (mg/kg) twice a day (BID) (5 mg/kg/day); after 1 week, the dose will be increased to 5 mg/kg BID (10 mg/kg/day). Dose escalation up to a maximum daily dosage of 20 mg/kg/day (in increments of 5 mg/kg/day [2.5 mg/kg BID] no more rapidly than every 7 days) may occur after Day 15 based on the investigator's assessment of efficacy, safety and tolerability.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive the matching placebo.
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?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,356 Total Patients Enrolled
16 Trials studying Epilepsy
1,845 Patients Enrolled for Epilepsy

Media Library

GWP42003-P Clinical Trial Eligibility Overview. Trial Name: NCT05288283 — Phase 3
Epilepsy Research Study Groups: Placebo, GWP42003-P
Epilepsy Clinical Trial 2023: GWP42003-P Highlights & Side Effects. Trial Name: NCT05288283 — Phase 3
GWP42003-P 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288283 — Phase 3

Frequently Asked Questions

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

Is there an age limit for participants in this particular research project?

"In order to take part in this research, potential participants must be aged 1-18. Out of the total 316 clinical trials, 126 are for people under 18 years old and 190 are for those over 65."

Answered by AI

Are there any safety concerns associated with taking GWP42003-P?

"There is existing data that suggests GWP42003-P's efficacy and safety, so it was given a score of 3."

Answered by AI

Are there any open slots for new volunteers in this clinical trial?

"Indeed, the most recent information available on clinicaltrials.gov points to this trial recruiting patients as we speak. This particular study was first advertised on October 31st 2020 and updated November 14th 2020. There is a need for 240 individuals at 1 site location."

Answered by AI

How many individuals can join this clinical trial?

"The information available on clinicaltrials.gov verifies that this study is currently recruiting patients. The trial was posted on October 31st, 2020 and updated two weeks ago on November 14th. They are looking for a total of 240 subjects at a single location."

Answered by AI

For whom is this trial designed?

"This trial is looking for 240 participants that suffer from seizures and are between 1 year old to 18 years old. Eligibility requirements include the following: contraceptive use by both male and female participants must follow Clinical Trial Facilitation Group (CTFG) guidelines, females cannot be pregnant or lactating, have a negative serum pregnancy test at Screening , confirmed negative urine pregnancy test before receiving IMP at Part A Visit 3, continuing to Part B with a negative urine pregnancy test result before receiving GWP42003-P, diagnosis of epilepsy with myoclonic-atonic seizures consistent with ILAE guidelines, initial seizure onset occurred 6 months to"

Answered by AI
~1 spots leftby Mar 2025