Trial · NCT01278173
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
NCT01278173, Phase 4, Completed, Lundbeck LLC; results first posted 2016-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®). Trials, record NCT01278173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01278173
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
- NCT number
- NCT01278173
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 65 participants, actual
- Lead sponsor
- Lundbeck LLC
- Conditions
- Adult Refractory Complex Partial Seizures
- Interventions
- Sabril
- First posted
- 2011-01-17
- Last updated
- 2016-06-07
- Results first posted
- 2016-06-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 | Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field. |
| Primary | Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography) | Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 | Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease. |
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 | Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 | All patients who had received at least one dose of investigational medicinal product and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x). | dB | MEAN |
| PRIMARY | Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography) | Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 | All patients who had received at least one dose of IMP and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x). | µm | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Left eye, 3 months (N=50) | -0.28 | Standard Deviation 1.06 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Left eye, 6 months (N=45) | -0.24 | Standard Deviation 1.13 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Left eye, 9 months (N=39) | -0.14 | Standard Deviation 1.72 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Left eye, 12 months (N=36) | -0.13 | Standard Deviation 1.58 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Right eye, 3 months (N=50) | 0.08 | Standard Deviation 1.20 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Right eye, 6 months (N=45) | -0.11 | Standard Deviation 1.40 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Right eye, 9 months (N=39) | 0.02 | Standard Deviation 1.36 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | VFRC database: Right eye, 12 months (N=36) | -0.27 | Standard Deviation 1.61 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | HFA database: Left eye, 3 months (N=51) | -0.32 | Standard Deviation 1.13 | dB |
| Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) | Sabril | HFA database: Left eye, 6 months (N=45) | -0.37 | Standard Deviation 1.15 | dB |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sabril | 65 | |
| Overall Study | COMPLETED | Sabril | 38 | |
| Overall Study | NOT COMPLETED | Sabril | 27 |
Source ClinicalTrials.gov
Adverse events23
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 | Vision blurred | Eye disorders | Vigabatrin | 6 | 65 | |
| other | Diarrhoea | Gastrointestinal disorders | Vigabatrin | 4 | 65 | |
| other | Fatigue | General disorders | Vigabatrin | 4 | 65 | |
| other | Fall | Injury, poisoning and procedural complications | Vigabatrin | 8 | 65 | |
| other | Weight increased | Investigations | Vigabatrin | 5 | 65 | |
| other | Convulsion | Nervous system disorders | Vigabatrin | 13 | 65 | |
| other | Dizziness | Nervous system disorders | Vigabatrin | 7 | 65 | |
| other | Somnolence | Nervous system disorders | Vigabatrin | 4 | 65 | |
| other | Depression | Psychiatric disorders | Vigabatrin | 4 | 65 | |
| other | Suicidal ideation | Psychiatric disorders | Vigabatrin | 4 | 65 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vigabatrin | ||
| Total, other adverse events | Vigabatrin | 41 | 65 |
| Total, serious adverse events | Vigabatrin | 9 | 65 |
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/NCT01278173
GET https://conductscience.org/api/trials/v1/NCT01278173/results?page=2