Childhood Absence EpilepsyPhase 2NCT03336242
Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
A Phase 2 study testing Cannabidiol Oral Solution in people with Childhood Absence Epilepsy, run by Radius Pharmaceuticals, Inc. at 11 sites in United States.
Trial summary
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Childhood Absence Epilepsy
- What is being tested?
- Cannabidiol Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 11 sitesUnited States
- Study dates
- 29 Dec 2017to 29 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient and/or parent(s)/caregiver(s) fully comprehend the informed consent form and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
- Male or female between 3 and 12 years (inclusive) at the time of onset and between 3 and 17 years of age (inclusive) at the time of consent.
- Body weight ≥ 10 kg.
- Diagnosed with childhood absence epilepsy, confirmed by electroencephalogram (EEG) with at least 3 bursts of general spike wave of 2.7 to 5 hertz lasting ≥3 seconds during the 4-hour EEG, and has had an adequate trial of at least 2 antiepileptic drugs (AEDs) and are treatment-resistant to at least one AED.
- Willingness to not start a ketogenic diet during the Baseline or Treatment Period.
- A female patient is eligible to participate in the study if she is premenarchal, or of childbearing potential with a negative urine pregnancy test at the Screening Visit. If sexually active, she must agree to either complete abstinence from intercourse or use acceptable methods of contraception throughout the study and for 4 weeks after completion of study participation or discontinuation from investigational product.
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- A sexually active male patient must be willing to use acceptable methods of contraception throughout the study and for 4 weeks after completion of study participation or discontinuation from investigational product.
- In the opinion of the investigator, the parent(s)/caregiver(s) is willing and able to comply with the study procedures and visit schedules and the Follow-up Visits.
- General good health based on physical and neurological examinations, medical history, and clinical laboratory values completed during the Screening Visit that would prohibit the patient from safely participating in the trial as judged by the investigator.
Who cannot join
- Patient or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits.
- Has a history of nonfebrile seizures other than absence seizures.
- Has a history of febrile seizures after 3 years of age.
- Has a history consistent with juvenile absence epilepsy or juvenile myoclonic epilepsy.
- Currently taking felbamate.
- Currently taking phenytoin, fluvoxamine, carbamazepine, or St. John's Wort.
Show all 20Show fewer
- Currently taking concomitant medications that are strong inhibitors/inducers/sensitive substrates with a narrow therapeutic index for cytochrome P450 3A4 (CYP3A4), CYP2C9, or CYP2C19. (Stable doses of Valproic Acid during the screening, titration, treatment, and follow-up periods are permitted).
- Currently on a ketogenic diet.
- In the opinion of the investigator, any clinically significant, unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems.
- Clinically significant abnormal liver function test (LFT) values, including albumin, direct bilirubin, total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN).
- History or presence of abnormal electrocardiograms (ECGs) that are clinically significant in the opinion of the investigator.
- Has a current or history of clinically significant intellectual disability or major psychiatric disease, including autism spectrum disorder, which would interfere with compliance.
- For patients aged 7 to 17 years of age and for whom the Columbia Suicide Severity Rating Scale (C-SSRS) is developmentally appropriate, an affirmative answer to queries regarding active suicidal ideation with some intent to act but without a specific plan or active suicidal ideation with a specific plan and intent on the C-SSRS assessment at the Screening Visit.
- Any history of attempted suicide.
- Previously received any investigational drug or device or investigational therapy within 30 days before Screening.
- Taken any cannabinoids in the 30 days prior to the Screening Visit.
- History of an allergic reaction or a known or suspected sensitivity to any substance that is contained in the investigational product formulation.
- Known infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- In the opinion of the investigator, the patient is unsuitable in any other way to participate in this study.
- Body weight <10 kg or >90 kg.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Akron Children's Hospital
Akron, Ohio, 44308
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Clinical Research Center of Nevada
Henderson, Nevada, 89052
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Specialty Group, Division of Child & Adolescent Neurology
Norfolk, Virginia, 23510
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
Primary Children's Hospital
Salt Lake City, Utah, 84113
Research and Innovation/MultiCare Health System
Tacoma, Washington, 98405
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609
About this study
Official title: A Phase 2, Open-label, Dose-finding Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures. This study will also assess safety, tolerability and pharmacokinetics of Cannabidiol Oral Solution, and any improvement in qualitative assessments of participant status over the duration of the study in pediatric participants with treatment-resistant childhood absence seizures. The study will include a 4-week Screening Period, a 5 or 10 day Titration Period (depending study Cohort), a 4-week Treatment Period followed by 5-day Tapering for doses >20 mg/kg/day and a 4-week Follow-up Period.
- Conditions
- Childhood Absence Epilepsy
- Being tested
- Cannabidiol Oral Solution
- Medical subject headings
- Epilepsy, Absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol Oral SolutionDrug
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Cannabidiol Oral Solution 20 mg/kg/day | Experimental | Treatment Period: Cannabidiol Oral Solution 20 milligrams per kilogram per day (mg/kg/day) divided twice daily (BID) for 4 weeks. Receives: Drug: Cannabidiol Oral Solution |
| Cohort 2: Cannabidiol Oral Solution 30 mg/kg/day | Experimental | Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days.
Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Receives: Drug: Cannabidiol Oral Solution |
| Cohort 3: Cannabidiol Oral Solution 10 mg/kg/day | Experimental | Treatment Period: Cannabidiol Oral Solution 10 mg/kg/day divided BID for 4 weeks. Receives: Drug: Cannabidiol Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Absence Seizure Counts Assessed by Video-electroencephalogram (EEG) at Visit 5
A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. A negative change value indicates an improvement in seizure activity. A positive change value indicates a worsening in seizure activity. Percent change from baseline was calculated as (100*(week 4-baseline)/baseline).
Measured: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)
Percent Change From Baseline in Time to Absence Seizure During Hyperventilation Testing on Video-EEG at Visit 5
A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. Percent change from baseline calculated as (100*(week 4-baseline)/baseline).
Measured: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)
Number of Participants Seizure-Free at Visit 5
Daily seizure activity was recorded in a diary. Each day, the participant or parent/caregiver responded to the question: "How many absence seizures did the patient have today?".
Measured: Visit 5 (Week 4, Day 6 of Treatment Period)
Clinical Global Impression of Improvement (CGI-I) Score at Visit 5
The CGI-I questionnaire was completed by the parents/caregivers and the investigator and was used to assess participants' global status of their condition at Week 4 of the Treatment Period using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.
Measured: Visit 5 (Week 4, Day 6 of Treatment Period)
Secondary outcomes (4)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A treatment-emergent AE is an AE with onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported AEs module.
Measured: Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period)
Maximum Plasma Concentration (Cmax) and Dose-normalized Cmax (Cmax/D) for Cannabidiol Under Fed and Fasted Conditions
The Cmax and Cmax/D for cannabidiol were evaluated under fed and fasted conditions.
Fed: Participant arrived at the site on Day 1 of Week 4 of the Treatment Period without food and the morning dose. The site provided a high fat/high-calorie food and then dosed the participant. Blood samples were collected pre-dose (before meal/morning dose) and 2, 4, and 6 hours after the morning dose (but before the next dose).
Fasted (2 hours before dose until 2 hours after dose): Participants arrived at the site on Day 2 of Week 4 of the Treatment Period without food and the morning dose. The site provided a standard meal 2 hours after the dose. Blood samples were collected pre-dose and 2 (before meal), 4, 6 hours after the morning dose (but before the next dose).
Measured: Visit 3 (Week 1, Day 1 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), Visit 5 (Week 4, Day 6 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), and Visit 6 (Week 4, Day 7 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose)
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured Concentration (AUC(0-t)) and Dose Normalized AUC(0-t) [AUC(0-t)/Dose] for Cannabidiol Under Fed and Fasted Conditions
The AUC(0-t) and AUC(0-t)/dose for cannabidiol were evaluated under fed and fasted conditions.
Fed: Participant arrived at the site on Day 1 of Week 4 of the Treatment Period without food and the morning dose. The site provided a high fat/high-calorie food and then dosed the participant. Blood samples were collected pre-dose (before meal/morning dose) and 2, 4, and 6 hours after the morning dose (but before the next dose).
Fasted (2 hours before dose until 2 hours after dose): Participants arrived at the site on Day 2 of Week 4 of the Treatment Period without food and the morning dose. The site provided a standard meal 2 hours after the dose. Blood samples were collected pre-dose and 2 (before meal), 4, 6 hours after the morning dose (but before the next dose).
Measured: Visit 3 (Week 1, Day 1 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), Visit 5 (Week 4, Day 6 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), and Visit 6 (Week 4, Day 7 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose)
Trough Plasma Concentration (Ctrough) and Dose Normalized Ctrough (Ctrough/Dose) for Cannabidiol Under Fed, Fasted, and Normal Conditions
The Ctrough and Ctrough/dose for cannabidiol were evaluated under fed, fasted, and normal conditions.
Fed: Participant arrived at the site on Day 1 of Week 4 of the Treatment Period without food and the morning dose. The site provided a high fat/high-calorie food and then dosed the participant. Blood samples were collected pre-dose (before meal/morning dose) and 2, 4, and 6 hours after the morning dose (but before the next dose).
Fasted (2 hours before dose until 2 hours after dose): Participants arrived at the site on Day 2 of Week 4 of the Treatment Period without food and the morning dose. The site provided a standard meal 2 hours after the dose. Blood samples were collected pre-dose and 2 (before meal), 4, 6 hours after the morning dose (but before the next dose).
Measured: Visit 3 (Week 1, Day 1 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), Visit 5 (Week 4, Day 6 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), and Visit 6 (Week 4, Day 7 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start29 Dec 2017
- Primary completion15 May 2019
- Study completion29 May 2019
Why it stopped: More patients in Cohort 1 than Cohort 2 demonstrated a clinically meaningful reduction of seizure count. Given this, enrollment of Cohort 3 was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood Absence EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Elkashef, MD, Study director, INSYS Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336242
- Sponsor's protocol ID
- INS011-17-103
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2017
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Dose-finding Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures
- ClinicalTrials.gov ID
- NCT03336242
- Acronym / sponsor ID
- INS011-17-103
- Conditions
- Childhood Absence Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: More patients in Cohort 1 than Cohort 2 demonstrated a clinically meaningful reduction of seizure count. Given this, enrollment of Cohort 3 was discontinued.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radius Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 21 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures. This study will also assess safety, tolerability and pharmacokinetics of Cannabidiol Oral Solution, and any improvement in qualitative assessments of participant status over the duration of the study in pediatric participants with treatment-resistant childhood absence seizures. The study will include a 4-week Screening Period, a 5 or 10 day Titration Period (depending study Cohort), a 4-week Treatment Period followed by 5-day Tapering for doses >20 mg/kg/day and a 4-week Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Cannabidiol Oral Solution 20 mg/kg/day | Experimental | Drug: Cannabidiol Oral SolutionTreatment Period: Cannabidiol Oral Solution 20 milligrams per kilogram per day (mg/kg/day) divided twice daily (BID) for 4 weeks. |
| Cohort 2: Cannabidiol Oral Solution 30 mg/kg/day | Experimental | Drug: Cannabidiol Oral SolutionTitration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. |
| Cohort 3: Cannabidiol Oral Solution 10 mg/kg/day | Experimental | Drug: Cannabidiol Oral SolutionTreatment Period: Cannabidiol Oral Solution 10 mg/kg/day divided BID for 4 weeks. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patient and/or parent(s)/caregiver(s) fully comprehend the informed consent form and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
- Male or female between 3 and 12 years (inclusive) at the time of onset and between 3 and 17 years of age (inclusive) at the time of consent.
- Body weight ≥ 10 kg.
- Diagnosed with childhood absence epilepsy, confirmed by electroencephalogram (EEG) with at least 3 bursts of general spike wave of 2.7 to 5 hertz lasting ≥3 seconds during the 4-hour EEG, and has had an adequate trial of at least 2 antiepileptic drugs (AEDs) and are treatment-resistant to at least one AED.
- Willingness to not start a ketogenic diet during the Baseline or Treatment Period.
Key exclusion criteria (20 listed)
- Patient or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits.
- Has a history of nonfebrile seizures other than absence seizures.
- Has a history of febrile seizures after 3 years of age.
- Has a history consistent with juvenile absence epilepsy or juvenile myoclonic epilepsy.
- Currently taking felbamate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol Oral SolutionAn oral solution containing pharmaceutical grade cannabidiol (nonplant-based). | Drug | Cohort 1: Cannabidiol Oral Solution 20 mg/kg/day, Cohort 2: Cannabidiol Oral Solution 30 mg/kg/day, Cohort 3: Cannabidiol Oral Solution 10 mg/kg/day |
Primary outcome
Percent Change From Baseline in Absence Seizure Counts Assessed by Video-electroencephalogram (EEG) at Visit 5
Time frame: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)
A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. A negative change value indicates an improvement in seizure activity. A positive change value indicates a worsening in seizure activity. Percent change from baseline was calculated as (100*(week 4-baseline)/baseline).
Percent Change From Baseline in Time to Absence Seizure During Hyperventilation Testing on Video-EEG at Visit 5
Time frame: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)
A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. Percent change from baseline calculated as (100*(week 4-baseline)/baseline).
Number of Participants Seizure-Free at Visit 5
Time frame: Visit 5 (Week 4, Day 6 of Treatment Period)
Daily seizure activity was recorded in a diary. Each day, the participant or parent/caregiver responded to the question: "How many absence seizures did the patient have today?".
Clinical Global Impression of Improvement (CGI-I) Score at Visit 5
Time frame: Visit 5 (Week 4, Day 6 of Treatment Period)
The CGI-I questionnaire was completed by the parents/caregivers and the investigator and was used to assess participants' global status of their condition at Week 4 of the Treatment Period using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.
4 secondary outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period)
Maximum Plasma Concentration (Cmax) and Dose-normalized Cmax (Cmax/D) for Cannabidiol Under Fed and Fasted Conditions
Time frame: Visit 3 (Week 1, Day 1 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), Visit 5 (Week 4, Day 6 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), and Visit 6 (Week 4, Day 7 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose)
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured Concentration (AUC(0-t)) and Dose Normalized AUC(0-t) [AUC(0-t)/Dose] for Cannabidiol Under Fed and Fasted Conditions
Time frame: Visit 3 (Week 1, Day 1 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), Visit 5 (Week 4, Day 6 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), and Visit 6 (Week 4, Day 7 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose)
Trough Plasma Concentration (Ctrough) and Dose Normalized Ctrough (Ctrough/Dose) for Cannabidiol Under Fed, Fasted, and Normal Conditions
Time frame: Visit 3 (Week 1, Day 1 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), Visit 5 (Week 4, Day 6 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), and Visit 6 (Week 4, Day 7 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elkashef, MD study director
INSYS Therapeutics Inc
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol Oral Solution in people with Childhood Absence Epilepsy, run by Radius Pharmaceuticals, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Absence Seizure Counts Assessed by Video-electroencephalogram (EEG) at Visit 5 (time frame: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.