A Phase 2 interventional study of Cannabidiol Oral Solution in Childhood Absence Epilepsy, sponsored by Radius Pharmaceuticals, Inc.. Terminated at 11 sites in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Radius Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
24 studies on the registry are indexed under Epilepsy, Absence; 2 are open to participants now.
This study's enrollment of 20 is close to the median of 20 across 17 interventional studies indexed under Epilepsy, Absence.
Browse Epilepsy, Absence studies →Radius Pharmaceuticals, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment Period: Cannabidiol Oral Solution 20 milligrams per kilogram per day (mg/kg/day) divided twice daily (BID) for 4 weeks.
Drug: Cannabidiol Oral Solution
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.
Drug: Cannabidiol Oral Solution
Treatment Period: Cannabidiol Oral Solution 10 mg/kg/day divided BID for 4 weeks.
Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
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).
Time frame: 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).
Time frame: 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?".
Time frame: 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.
Time frame: Visit 5 (Week 4, Day 6 of Treatment Period)
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.
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
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).
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
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).
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
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).
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)
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 9 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
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 | Cohort 1 | Cohort 2 |
|---|---|---|
| Percent Change From Baseline in Absence Seizure Counts Assessed by Video-electroencephalogram (EEG) at Visit 5 | 40.67 ± 180.919 | 35.12 ± 121.518 |
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).
| percent change | Cohort 1 | Cohort 2 |
|---|---|---|
| Percent Change From Baseline in Time to Absence Seizure During Hyperventilation Testing on Video-EEG at Visit 5 | 162.24 ± 344.028 | 64.51 ± 115.502 |
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?".
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Number of Participants Seizure-Free at Visit 5 | 1 | 0 |
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.
| units on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Clinical Global Impression of Improvement (CGI-I) Score at Visit 5 | 2.9 ± 0.88 | 3.1 ± 0.99 |
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.
| participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Number of participants with AEs | 6 | 7 |
| Number of participants with SAEs | 0 | 0 |
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
Collected over Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Cohort 2 | 0/10 (0%) | 0/10 (0%) | 7/10 (70%) |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| Viral upper respiratory tract infectionInfections and infestations | 0/10 | 4/10 |
| FallInjury, poisoning and procedural complications | 4/10 | 0/10 |
| HeadacheNervous system disorders | 0/10 | 3/10 |
| Abdominal pain upperGastrointestinal disorders | 0/10 | 2/10 |
| SeizureNervous system disorders | 0/10 | 2/10 |
| Tympanic membrane perforationEar and labyrinth disorders | 0/10 | 1/10 |
| VomitingGastrointestinal disorders | 1/10 | 1/10 |
| DiarrhoeaGastrointestinal disorders | 0/10 | 1/10 |
| RetchingGastrointestinal disorders | 1/10 | 0/10 |
| FatigueGeneral disorders | 1/10 | 1/10 |
All participants who were enrolled and received at least 1 dose of study drug. No participants enrolled in Cohort 3.
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 8.8 ± 2.74 | 8.0 ± 3.02 | 8.4 ± 2.84 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 8 | 10 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 10 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabidiol
Radius Pharmaceuticals, Inc.