Trial · NCT02551731
Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
NCT02551731, Phase 2, Terminated, INSYS Therapeutics Inc; results first posted 2018-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms. Trials, record NCT02551731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02551731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
- NCT number
- NCT02551731
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- INSYS Therapeutics Inc
- Conditions
- Spasms, Infantile
- Interventions
- Cannabidiol Oral Solution
- First posted
- 2015-09-16
- Last updated
- 2018-09-19
- Results first posted
- 2018-09-19
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14 | Day 14 | Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-electroencephalogram (EEG) at Day 14. |
| Primary | Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs) | Up to Week 64 | |
| Secondary | Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14 | Day 14 | |
| Secondary | Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14 | Day 14 | |
| Secondary | Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14 | Baseline, Day 14 | |
| Secondary | Part A: Parent Impression of Efficacy and Tolerability of Study Drug | Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. | Parent impression of efficacy and tolerability, as measured by Clinical Global Impression-Global Improvement Scale (CGI-I), was summarized by visit and status of response (Complete/Partial and No Response) at Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. The CGI-I was also analyzed in a continuous scale, as follows: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse |
| Secondary | Part A: Percentage of Participants With a Partial Response to Treatment | Day 14 | Partial response was defined as a substantive change in background EEG or reduction in spasms on video EEG obtained at Day 14. |
| Secondary | Part A: Percentage of Complete Responders With Relapse | Day 14 | Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14. |
| Secondary | Part A: Time to Complete Responder Relapse | Day 14 | Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14. |
| Secondary | Part B: Parent Impression of Efficacy and Tolerability of Study Drug as Measured by the Change in Clinical Global Impression of Improvement Assessment (CGI-I), Responses at Every Visit Throughout Part B | Up to Week 64 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14 | Day 14 | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Percentage of participants | NUMBER |
| PRIMARY | Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs) | Up to Week 64 | Safety Analysis Population: included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14 | Day 14 | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14 | Day 14 | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14 | Baseline, Day 14 | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Number of spasms | MEDIAN |
| SECONDARY | Part A: Parent Impression of Efficacy and Tolerability of Study Drug | Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Units on a scale | MEAN |
| SECONDARY | Part A: Percentage of Participants With a Partial Response to Treatment | Day 14 | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Complete Responders With Relapse | Day 14 | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Time to Complete Responder Relapse | Day 14 | Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14. | Days | NUMBER |
| SECONDARY | Part B: Parent Impression of Efficacy and Tolerability of Study Drug as Measured by the Change in Clinical Global Impression of Improvement Assessment (CGI-I), Responses at Every Visit Throughout Part B | Up to Week 64 | Due to concerns of participant confidentiality this outcome measure was not analyzed. Only 1 participant participated in Part B due to study termination. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14 | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | 14.3 | Percentage of participants | ||
| Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs) | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | AEs | 44.4 | Percentage of participants | |
| Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs) | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | TEAEs | 33.3 | Percentage of participants | |
| Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs) | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | SAEs | 0.0 | Percentage of participants | |
| Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14 | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | 42.9 | Percentage of participants | ||
| Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14 | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | 42.9 | Percentage of participants | ||
| Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14 | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | Visit 1(Baseline) | 0.0 | Inter-Quartile Range 0 to 3 | Number of spasms |
| Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14 | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | Visit 3 (Day 14) | 9.0 | Inter-Quartile Range 8 to 10 | Number of spasms |
| Part A: Parent Impression of Efficacy and Tolerability of Study Drug | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | Visit 3 (Day 14) | 3.0 | Standard Deviation 1.0 | Units on a scale |
| Part A: Parent Impression of Efficacy and Tolerability of Study Drug | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | Visit 4 (Week 4) | 1.0 | Standard Deviation NA | Units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | 9 | |
| Overall Study | COMPLETED | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | 7 | |
| Overall Study | NOT COMPLETED | Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID | 2 |
Source ClinicalTrials.gov
Adverse events6
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 | Infantile Spasms | Nervous system disorders | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 3 | 9 | |
| other | Infection | Infections and infestations | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 1 | 9 | |
| other | Influenza | Infections and infestations | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 1 | 9 | |
| other | Irritability | Psychiatric disorders | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 1 | 9 | |
| other | Sedation | Nervous system disorders | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 1 | 9 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 1 | 9 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 0 | 9 |
| Total, other adverse events | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 4 | 9 |
| Total, serious adverse events | Cannabidiol Oral Solution: 20-40 mg/kg/Day BID | 0 | 9 |
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/NCT02551731
GET https://conductscience.org/api/trials/v1/NCT02551731/registered