Trial Outcomes & Findings for 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 NCT00856635)

Last Updated: 2018-02-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

44 participants

Primary outcome timeframe

Baseline and Month 6

Results posted on

2018-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Glatiramer Acetate Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.	Placebo Participants received placebo subcutaneous injection once a day for up to 6 months.
Overall Study STARTED	22	22
Overall Study Received Study Drug	20	20
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Glatiramer Acetate Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.	Placebo Participants received placebo subcutaneous injection once a day for up to 6 months.
Overall Study Lost to Follow-up	2	5
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	3	1
Overall Study Serious Adverse Event	1	0
Overall Study Other	1	0
Overall Study Discontinued at Randomization	2	2

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glatiramer Acetate n=20 Participants Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.	Placebo n=20 Participants Participants received placebo subcutaneous injection once a day for up to 6 months.	Total n=40 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 7.1 • n=5 Participants	34.4 years STANDARD_DEVIATION 6.5 • n=7 Participants	33.0 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Glatiramer Acetate n=18 Participants Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.	Placebo n=18 Participants Participants received placebo subcutaneous injection once a day for up to 6 months.
Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 Baseline (n=18, 18)	128.1 µm Standard Deviation 11.9	130.5 µm Standard Deviation 8.9
Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 Month 6 (n=13, 13)	89.5 µm Standard Deviation 8.9	88.0 µm Standard Deviation 5.5

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Glatiramer Acetate

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Glatiramer Acetate n=20 participants at risk Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.	Placebo n=20 participants at risk Participants received placebo subcutaneous injection once a day for up to 6 months.
Immune system disorders Drug Hypersensitivity	5.0% 1/20	0.00% 0/20

Other adverse events

Adverse event data not reported

Additional Information

Scott Kolodny, M.D.

Teva Pharmaceuticals, Medical Affairs

Phone: 440-327-1811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Publication restrictions are in place

Restriction type: OTHER