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NCT01278173 · ClinicalTrials.gov registry record · Phase 4
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
A Phase 4 study, sponsored by Lundbeck.
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
NCT01278173: Completed Phase 4 study, sponsored by Lundbeck.
NCT01278173 is a Phase 4 study that has completed, run by Lundbeck. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01278173, a Phase 4 study, has completed, sponsored by Lundbeck.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated with vigabatrin (Sabril®)
Primary Outcome
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 dec
Interventions
- DRUG Sabril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 4 |
What the finished NCT01278173 record still lists
NCT01278173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Sabril is the first listed.
NCT01278173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01278173 about?
NCT01278173 is a clinical study titled "A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)". The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated ...
What is the current status of trial NCT01278173?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2010-12. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01278173?
The interventions under investigation include: Sabril (DRUG).
Who is sponsoring clinical trial NCT01278173?
This trial is sponsored by Lundbeck, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01278173's enrollment target sits among peer trials
65 1091st of 2000 higher than 903 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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