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This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673) and INS011-15-054 (NCT02551731).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants | Experimental | Participants 1 to<2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The maximum daily dose was 40 mg/kg/day. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose, milligrams per kilograms per day (mg/kg/day), will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
| Children | Experimental | Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.The maximum daily dose was 40 mg/kg/day. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
| Adolescents | Experimental | Participants 12 to <17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The maximum daily dose was 40 mg/kg/day. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol Oral Solution | Drug | An oral solution containing pharmaceutical grade cannabidiol (nonplant-based). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | 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. | Up to Week 50 |
| Percentage of Participants With Serious Adverse Events | 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. | Up to Week 50 |
| Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values | Laboratory values include chemistry and hematology, and urinary analysis. | Up to Week 50 |
| Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Up to Week 48 | |
| Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs | Up to Week 50 | |
| Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite | Up to Week 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Vineland Adaptive Behavior Scales (VABS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) | 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. |
Inclusion Criteria:
Exclusion Criteria:
Inadequate supervision by parent(s)/caregiver(s)
History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Neha Parikh | INSYS Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Infants | Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2017 | Jun 26, 2018 |
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|
| Up to Week 48 |
| Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Up to Week 50 |
| through study completion, up to 48 weeks or marketing approval, whichever is earlier |
| Impact of Pediatric Epilepsy Scale (IPES) | 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. | through study completion, up to 48 weeks or marketing approval, whichever is earlier |
| Clinical Global Impression of Improvement (CGI-I) | The participant's overall clinical condition is compared to the one week period just before the start of medication (the baseline visit). The participant's condition is compared to the patient's condition at admission to the project [prior to starting treatment] on a 7-point scale, where 1=very much improved since the initiation of treatment; and 7=very much worse since the initiation of treatment. The CGI-I will be completed for all participants, regardless of chronological and developmental age. | through study completion, up to 48 weeks or marketing approval, whichever is earlier |
| Change From Baseline in Frequency of Seizures as a Measure of Seizure Control | through study completion, up to 48 weeks or marketing approval, whichever is earlier |
| Miami Children's Hospital |
| Miami |
| Florida |
| 33155 |
| United States |
| Child Neurology Center - NW F | Pensacola | Florida | 32504 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Clinical Research Center of Nevada LLC | Las Vegas | Nevada | 89104 | United States |
| Oregon Health Services University | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Texas Scottish Rite Hospital for Children | Dallas | Texas | 79219 | United States |
| Granger Medical Clinic | Riverton | Utah | 84096 | United States |
| Mary Bridge Children's Hospital | Tacoma | Washington | 98403 | United States |
| FG001 | Children | Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| FG002 | Adolescents | Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infants | Participants 1 to <2 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| BG001 | Children | Participants 2 to <12 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| BG002 | Adolescents | Participants 12 to <17 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | 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. | Posted | Number | Percentage of participants | Up to Week 50 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events | 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. | Posted | Number | Percentage of participants | Up to Week 50 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values | Laboratory values include chemistry and hematology, and urinary analysis. | Posted | Number | Percentage of participants | Up to Week 50 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Posted | Number | Percentage of participants | Up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs | Posted | Number | Percentage of participants | Up to Week 50 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite | Insufficient data was collected to perform study analysis. | Posted | Up to Week 50 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Vineland Adaptive Behavior Scales (VABS) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Up to Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Posted | Count of Participants | Participants | Up to Week 50 |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Clinical Global Impression of Severity (CGI-S) | 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. | Not Posted | through study completion, up to 48 weeks or marketing approval, whichever is earlier | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Impact of Pediatric Epilepsy Scale (IPES) | 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. | Not Posted | through study completion, up to 48 weeks or marketing approval, whichever is earlier | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Clinical Global Impression of Improvement (CGI-I) | The participant's overall clinical condition is compared to the one week period just before the start of medication (the baseline visit). The participant's condition is compared to the patient's condition at admission to the project [prior to starting treatment] on a 7-point scale, where 1=very much improved since the initiation of treatment; and 7=very much worse since the initiation of treatment. The CGI-I will be completed for all participants, regardless of chronological and developmental age. | Not Posted | through study completion, up to 48 weeks or marketing approval, whichever is earlier | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Frequency of Seizures as a Measure of Seizure Control | Not Posted | through study completion, up to 48 weeks or marketing approval, whichever is earlier | Participants |
Up to Week 50
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infants | Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. | 1 | 9 | 7 | 9 | 8 | 9 |
| EG001 | Children | Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. | 0 | 26 | 10 | 26 | 24 | 26 |
| EG002 | Adolescents | Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. | 0 | 17 | 0 | 17 | 15 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Change in seizure presentation | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Physical assault | Social circumstances | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Vestibulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Change in seizure presentation | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Clumsiness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fontanelle bulging | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Postictal paralysis | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Flat affect | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Head banging | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Device expulsion | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Device failure | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Human rhinovirus test positive | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary valve incompetence | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 18.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | Insys Therapeutics, Inc. | 480-500-3105 | gdecastro@insysrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2017 | Jun 26, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D065768 | Lennox Gastaut Syndrome |
| D004831 | Epilepsies, Myoclonic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073376 | Epileptic Syndromes |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004829 | Epilepsy, Generalized |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Adolescents | Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| OG003 | All Participants | All participants who participated in the study. |
|
|
| OG002 | Adolescents | Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
|
| OG002 | Adolescents | Participants 12 to <17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
|
| OG002 | Adolescents | Participants 12 to <17 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
|
| OG002 | Adolescents | Participants 12 to <17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
| OG001 | Children | Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
| OG002 | Adolescents | Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
|
| OG002 | Adolescents | Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant. The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion. |
|
|