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NCT00316498 · ClinicalTrials.gov registry record · Phase 1
Saccadic Eye Movements in Patients With Niemann-Pick Type C Disease
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00316498 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 30 participants.
The verdict
NCT00316498, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is done in conjunction with a trial, conducted at Columbia University College of Physicians and Surgeons in New York and the Royal Manchester Children's Hospital in England, to examine the effectiveness of a new drug called OGT 918 for treating Niemann-Pick Type C (NPC) disease. Patients with this genetic disorder do not transport lipids (fatty substances) in their cells, resulting in problems of the liver, spleen and brain. An early sign of NPC is a reduced ability to move the eyes rapidly up and down or from side to side. These voluntary eye movements are called saccades. Patients in the OGT 918 trial who participate in this sub-study will have their saccadic eye movements measured to see if improvement occurs with OGT 918 treatment. Patients with Niemann-Pick Type C disease 12 years of age and older who are enrolled in the OGT 918 trial described above may be eligible for this study. Participants will have both vertical (up and down) and horizontal (side to side) saccadic eye movements measured at two time points before starting treatment with OGT 918 and after 12 months of treatment. For the test, patients sit in a chair with their head positioned as for a regular eye examination (steadied by a chin cup and headrest) and follow with their eyes a series of lights or laser spots moving on a screen at a distance of 1 meter (3 feet). During the test, patients wear either special recording glasses, infrared goggles, or special contact lenses for measuring eye movements. A full eye evaluation lasts about 1 hour, and each eye is evaluated twice. The evaluations are separated in time by at least an hour, and possibly a day.
Interventions
- DRUG OGT918
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-10-17 |
| Est. Completion | 2007-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00316498
The ClinicalTrials.gov registry entry for NCT00316498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OGT918 is the first listed.
NCT00316498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00316498 about?
NCT00316498 is a clinical study titled "Saccadic Eye Movements in Patients With Niemann-Pick Type C Disease". This study is done in conjunction with a trial, conducted at Columbia University College of Physicians and Surgeons in New York and the Royal Manchester Children's Hospital in England, to examine the effectiveness of a new drug called OGT 918 for treating Niemann-Pick Type C (NPC) disease. Patients ...
What is the current status of trial NCT00316498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2002-10-17. Estimated completion is 2007-08-15.
What interventions are being tested in trial NCT00316498?
The interventions under investigation include: OGT918 (DRUG).
Who is sponsoring clinical trial NCT00316498?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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