Trial · NCT02332655
Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome
NCT02332655, Phase 1, Phase 2, Completed, Anne Comi, MD; results first posted 2022-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome. Trials, record NCT02332655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02332655
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome
- NCT number
- NCT02332655
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Anne Comi, MD
- Conditions
- Sturge-Weber Syndrome
- Interventions
- Cannabidiol
- First posted
- 2015-01-07
- Last updated
- 2022-03-02
- Results first posted
- 2022-03-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Seizures Per Month | Measured within 56 days before baseline and 56 days before week 14 | A baseline seizure frequency was recorded for each subject in a diary for eight weeks prior to investigational drug initiation and parents/caregivers documented seizures on a daily basis throughout the trial using a seizure log. For assessing the efficacy of CBD, the investigator counted the change in frequency of seizures per month. The number of seizures within 56 days of the baseline and the number of seizures within 56 days of week 14 were calculated. Higher seizure frequency indicates worse outcome. This outcome is measured as the change in number of seizures per month between the baseline and week 14 time points. |
| Secondary | Percentage Change in Seizure Frequency at Most Recent Visit on CBD Compared With Baseline | Measured at Baseline and most recent visit within 1 year | The percentage change, between the seizure frequency per month reported at baseline compared to seizure frequency per month at the subject's most recent visit, on CBD was calculated. Higher positive percentage change in seizure frequency per month would indicate better outcome. Positive values indicate a decrease in seizure frequency. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seizures Per Month | Measured within 56 days before baseline and 56 days before week 14 | 4 out of 5 subjects were included in analysis as subject 5 was removed early (before week 14) due to lack of efficacy and adverse events. | Seizures per month | MEAN |
| SECONDARY | Percentage Change in Seizure Frequency at Most Recent Visit on CBD Compared With Baseline | Measured at Baseline and most recent visit within 1 year | 4 out of 5 subjects were included in analysis as subject 5 was removed early due to lack of efficacy. Data were not collected for Subject 5 as the subject was removed at week 9 due to lack of efficacy. | Percentage Change in Seizure Frequency | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Seizures Per Month | Cannabidiol | Subject 1 Overall Average Number of Seizures per Month at Baseline | 33.5 | Standard Deviation 7.78 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 1 Overall Average Number of Seizures per Month at Week 14 | 30.0 | Standard Deviation 2.83 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 2 Overall Average Number of Seizures per Month at Baseline | 3.0 | Standard Deviation 1.41 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 2 Overall Average Number of Seizures per Month at Week 14 | 0.5 | Standard Deviation 0.71 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 3 (Re-enrolled) Overall Average Number of Seizures per Month at Baseline | 3.0 | Standard Deviation 1.41 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 3 (Re-enrolled) Overall Average Number of Seizures per Month at Week 14 | 2.0 | Standard Deviation 0.00 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 4 Overall Average Number of Seizures per Month at Baseline | 5.0 | Standard Deviation 1.41 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 4 Overall Average Number of Seizures per Month at Week 14 | 0.5 | Standard Deviation 0.71 | Seizures per month |
| Number of Seizures Per Month | Cannabidiol | Subject 5 Overall Average Number of Seizures per Month at Baseline | 1.0 | Standard Deviation 0.00 | Seizures per month |
| Percentage Change in Seizure Frequency at Most Recent Visit on CBD Compared With Baseline | Cannabidiol | Subject 1 Percent decrease in Seizure Frequency at Most Recent Visit on CBD Compared with Baseline | 12 | Percentage Change in Seizure Frequency |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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 | 5 | |
| Overall Study | COMPLETED | Cannabidiol | 4 | |
| Overall Study | NOT COMPLETED | Cannabidiol | 1 |
Source ClinicalTrials.gov
Adverse events8
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 | Temporary increased seizures | Nervous system disorders | Cannabidiol | 3 | 5 | 3 |
| other | Behavioral Issues | Psychiatric disorders | Cannabidiol | 2 | 5 | 2 |
| other | Increased aspartate aminotransferase liver function test | Investigations | Cannabidiol | 1 | 5 | 1 |
| other | Right eye exotropia and redness/intermittent exotropia without redness | Eye disorders | Cannabidiol | 1 | 5 | 1 |
| other | Tiredness | General disorders | Cannabidiol | 1 | 5 | 1 |
| serious | Left Eye Vertical Nystagmus | Eye disorders | Cannabidiol | 1 | 5 | 1 |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Cannabidiol | 1 | 5 | 1 |
| serious | Facial Skin Infection | Skin and subcutaneous tissue disorders | Cannabidiol | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cannabidiol | 0 | 5 |
| Total, other adverse events | Cannabidiol | 5 | 5 |
| Total, serious adverse events | Cannabidiol | 3 | 5 |
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/NCT02332655
GET https://conductscience.org/api/trials/v1/NCT02332655/registered