Trial · NCT02318602
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
NCT02318602, Phase 3, Completed, INSYS Therapeutics Inc; results first posted 2018-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder. Trials, record NCT02318602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02318602
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
- NCT number
- NCT02318602
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 52 participants, actual
- Lead sponsor
- INSYS Therapeutics Inc
- Conditions
- Seizures
- Interventions
- Cannabidiol Oral Solution
- First posted
- 2014-12-17
- Last updated
- 2018-07-26
- Results first posted
- 2018-07-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | Up to Week 50 | An Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. |
| Primary | Percentage of Participants With Serious Adverse Events | Up to Week 50 | A serious adverse event is any untoward medical occurrence ( whether considered to be related to investigational product or not) that at any dose results in death, is life threatening, requires inpatient hospitalization, results in disability/incapacity, is a congenital abnormality/ birth defect, or medically significant as determined by an investigator. |
| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values | Up to Week 50 | Laboratory values include chemistry and hematology, and urinary analysis. |
| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Up to Week 48 | |
| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs | Up to Week 50 | |
| Primary | Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite | Up to Week 50 | |
| Secondary | Vineland Adaptive Behavior Scales (VABS) | Up to Week 48 | The Vineland Adaptive Behavior Scales measures the personal and social skills of individuals from birth through adulthood. Because adaptive behavior refers to an individual's typical performance of the day-to-day activities required for personal and social sufficiency, these scales assess what a person actually does, rather than what he or she is able to do. The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. The 4 domains are Communication, Daily Living Skills, Motor Skills, and Maladaptive Behaviour Index. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. A rise in standard scores from Baseline indicates improvement. The VABS will be completed for all participants. |
| Secondary | Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Week 50 | For subjects 7 years of developmental age or older, the Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered to access suicidality. The appropriate adult version will be used in subjects 12 years of (developmental) age and older. The investigator will determine the participant's developmental age. |
| Other | Clinical Global Impression of Severity (CGI-S) | through study completion, up to 48 weeks or marketing approval, whichever is earlier | The severity of the participant's illness is rated on a seven-point scale, where 1=normal, not at all ill, and 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The score reflects the average severity level across the seven days. The CGI-S will be completed for all participants, regardless of chronological and developmental age. |
| Other | Impact of Pediatric Epilepsy Scale (IPES) | through study completion, up to 48 weeks or marketing approval, whichever is earlier | The IPES assesses the impact on academic achievement, participation in activities, health, relationships with family and with peers and siblings, social activities, self-esteem, and the caregiver's hopes for their child's future. It takes about 3 minutes for the parent to complete. Each of the 11 items is given a severity score of 0 (not at all) to 3 (a lot). The higher the score, the higher is the impact of epilepsy on that item. The highest total score possible is 33 (range 0-33). The Impact of Pediatric Epilepsy Scale (IPES) is validated for subjects who are 2 to 16 years of age. Due to developmental delay characteristic of the study population, subjects through 18 years of chronological age will complete the IPES. Subjects over 18 years of chronological age will not complete the IPES. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events | Up to Week 50 | Percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants With Serious Adverse Events | Up to Week 50 | Percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values | Up to Week 50 | Percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Up to Week 48 | Percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs | Up to Week 50 | Percentage of participants | NUMBER | |
| PRIMARY | Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite | Up to Week 50 | Insufficient data was collected to perform study analysis. | ||
| SECONDARY | Vineland Adaptive Behavior Scales (VABS) | Up to Week 48 | The Safety Analysis Population (SAF) consisted of all participants in the enrolled population group (ENR) who received at least one dose of the investigational product. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Week 50 | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Clinical Global Impression of Severity (CGI-S) | through study completion, up to 48 weeks or marketing approval, whichever is earlier | |||
| OTHER_PRE_SPECIFIED | Impact of Pediatric Epilepsy Scale (IPES) | through study completion, up to 48 weeks or marketing approval, whichever is earlier |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events | Infants | 88.9 | Percentage of participants | ||
| Percentage of Participants With Adverse Events | Children | 92.3 | Percentage of participants | ||
| Percentage of Participants With Adverse Events | Adolescents | 88.2 | Percentage of participants | ||
| Percentage of Participants With Adverse Events | All Participants | 90.4 | Percentage of participants | ||
| Percentage of Participants With Serious Adverse Events | Infants | 77.8 | Percentage of participants | ||
| Percentage of Participants With Serious Adverse Events | Children | 38.5 | Percentage of participants | ||
| Percentage of Participants With Serious Adverse Events | Adolescents | 0 | Percentage of participants | ||
| Percentage of Participants With Serious Adverse Events | All Participants | 32.7 | Percentage of participants | ||
| Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values | Infants | Hematology | 0 | Percentage of participants | |
| Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values | Children | Hematology | 0 | Percentage of participants |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infants | 9 | |
| Overall Study | STARTED | Children | 26 | |
| Overall Study | STARTED | Adolescents | 17 | |
| Overall Study | COMPLETED | Infants | 8 | |
| Overall Study | COMPLETED | Children | 22 | |
| Overall Study | COMPLETED | Adolescents | 15 | |
| Overall Study | NOT COMPLETED | Infants | 1 | |
| Overall Study | NOT COMPLETED | Children | 4 | |
| Overall Study | NOT COMPLETED | Adolescents | 2 |
Source ClinicalTrials.gov
Adverse events339
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Infants | 1 | 9 | |
| other | Upper respiratory tract infection | Infections and infestations | Children | 6 | 26 | |
| other | Upper respiratory tract infection | Infections and infestations | Adolescents | 1 | 17 | |
| other | Nasopharyngitis | Infections and infestations | Infants | 1 | 9 | |
| other | Nasopharyngitis | Infections and infestations | Children | 3 | 26 | |
| other | Nasopharyngitis | Infections and infestations | Adolescents | 1 | 17 | |
| other | Otitis media | Infections and infestations | Infants | 0 | 9 | |
| other | Otitis media | Infections and infestations | Children | 5 | 26 | |
| other | Otitis media | Infections and infestations | Adolescents | 0 | 17 | |
| other | Influenza | Infections and infestations | Infants | 1 | 9 |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infants | 1 | 9 |
| Total, all-cause mortality | Children | 0 | 26 |
| Total, all-cause mortality | Adolescents | 0 | 17 |
| Total, other adverse events | Infants | 8 | 9 |
| Total, other adverse events | Children | 24 | 26 |
| Total, other adverse events | Adolescents | 15 | 17 |
| Total, serious adverse events | Infants | 7 | 9 |
| Total, serious adverse events | Children | 10 | 26 |
| Total, serious adverse events | Adolescents | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02318602
GET https://conductscience.org/api/trials/v1/NCT02318602/results?page=2