Trial · NCT00856635
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
NCT00856635, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2013-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon). Trials, record NCT00856635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00856635
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
- NCT number
- NCT00856635
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Optic Neuritis
- Interventions
- Glatiramer Acetate, placebo
- First posted
- 2009-03-06
- Last updated
- 2018-02-06
- Results first posted
- 2013-09-23
- Limitations and caveats
- Enrollment did not meet expectations, and target sample sizes were not met.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 | Baseline and Month 6 | Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6. |
| Secondary | To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters. | 6 months |
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 | Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 | Baseline and Month 6 | The modified ITT intent-to-treat (mITT) analysis set included all patients who had been randomized to the study, received at least one dose of study drug, had a baseline OCT evaluation, and had at least one non-missing post-baseline OCT evaluation. | µm | MEAN |
| SECONDARY | To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters. | 6 months | Enrollment did not meet expectations, and target sample sizes were not met. As a results, the secondary outcome was not analyzed. There were no data collected for this outcome; there is no data to analyze. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 | Glatiramer Acetate | Baseline (n=18, 18) | 128.1 | Standard Deviation 11.9 | µm |
| Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 | Placebo | Baseline (n=18, 18) | 130.5 | Standard Deviation 8.9 | µm |
| Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 | Glatiramer Acetate | Month 6 (n=13, 13) | 89.5 | Standard Deviation 8.9 | µm |
| Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 | Placebo | Month 6 (n=13, 13) | 88.0 | Standard Deviation 5.5 | µm |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glatiramer Acetate | 22 | |
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | Received Study Drug | Glatiramer Acetate | 20 | |
| Overall Study | Received Study Drug | Placebo | 20 | |
| Overall Study | COMPLETED | Glatiramer Acetate | 12 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Glatiramer Acetate | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Drug Hypersensitivity | Immune system disorders | Glatiramer Acetate | 1 | 20 | |
| serious | Drug Hypersensitivity | Immune system disorders | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glatiramer Acetate | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Glatiramer Acetate | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Glatiramer Acetate | 1 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Glatiramer Acetate vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00856635
GET https://conductscience.org/api/trials/v1/NCT00856635/registered