A Phase 2 interventional study of Cannabidiol Oral Solution in Childhood Absence Epilepsy, sponsored by Radius Pharmaceuticals, Inc.. Terminated at 9 sites in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Radius Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
24 studies on the registry are indexed under Epilepsy, Absence; 2 are open to participants now.
This study's enrollment of 11 is below 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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cannabidiol Oral solution, dose as assigned in INS-17-103.
Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant 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. An 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: Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks)
| Milestone | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Canabidiol Oral Solution 30 to <40 mg/kg/Day |
|---|---|---|
| Started | 5 | 6 |
| Completed | 2 | 4 |
| Not completed | 3 | 2 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Lack of efficacy | 2 | 1 |
| Withdrew: Other reason | 1 | 0 |
An AE is defined as any untoward medical occurrence in a participant 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. An 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 | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Canabidiol Oral Solution 30 to <40 mg/kg/Day |
|---|---|---|
| Number of participants with AEs | 5 | 4 |
| Number of participants with SAEs | 0 | 0 |
Collected over Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Canabidiol Oral Solution 20 to <30 mg/kg/Day | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Canabidiol Oral Solution 30 to <40 mg/kg/Day | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Event | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Canabidiol Oral Solution 30 to <40 mg/kg/Day |
|---|---|---|
| PyrexiaGeneral disorders | 1/5 | 0/6 |
| Seasonal allergyImmune system disorders | 1/5 | 0/6 |
| Coordination abnormalNervous system disorders | 1/5 | 0/6 |
| HeadacheNervous system disorders | 1/5 | 0/6 |
| SeizureNervous system disorders | 1/5 | 0/6 |
| SomnolenceNervous system disorders | 1/5 | 0/6 |
| HallucinationPsychiatric disorders | 1/5 | 0/6 |
| VomitingGastrointestinal disorders | 0/5 | 1/6 |
| FatigueGeneral disorders | 0/5 | 1/6 |
| Pharyngitis streptococcalInfections and infestations | 0/5 | 1/6 |
All participants who were enrolled and received at least 1 dose of study drug.
| Age, Continuous(years) | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Canabidiol Oral Solution 30 to <40 mg/kg/Day | Total |
|---|---|---|---|
| Mean | 8.4 ± 2.41 | 10.7 ± 3.01 | 9.6 ± 2.87 |
| Sex: Female, Male(Participants) | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Canabidiol Oral Solution 30 to <40 mg/kg/Day | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 1 | 4 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Canabidiol Oral Solution 30 to <40 mg/kg/Day | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 6 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Canabidiol Oral Solution 30 to <40 mg/kg/Day | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 6 | 11 |
| 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 May 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.