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)

Status: Completed
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: No
View:

• Age: 18 - 45 years

• Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances.

• Able to provide written informed consent prior to enrollment

• Willing and able to comply with the protocol requirements for the duration of the study

• For women of child bearing potential:

• A negative urine pregnancy test o

• Willing to practice an acceptable method of birth control •

• Willing to receive a steroidal regimen

Time Frame
Start Date: February 2009
Completion Date: February 2011
Participants
Target number of participants: 44
Treatments
Experimental: Glatiramer acetate
Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Placebo Comparator: Placebo
Participants received placebo subcutaneous injection once a day for up to 6 months.
Sponsors
Leads: Teva Branded Pharmaceutical Products R&D, Inc.

This content was sourced from clinicaltrials.gov