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 | Completed Phase 3 Results

• 1 other identifier: PM030
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Optic Neuritis

Outcome Measures

Primary Outcomes (1)

• Retinal Nerve Fiber Layer Thickness at 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.

  Baseline and Month 6

Secondary Outcomes (1)

• To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.

  6 months

Study Arms (2)

Glatiramer acetate

EXPERIMENTAL

Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.

Drug: Glatiramer Acetate

Placebo

PLACEBO COMPARATOR

Participants received placebo subcutaneous injection once a day for up to 6 months.

Drug: placebo

Interventions

Glatiramer Acetate DRUG

20 mg injected daily subcutaneously

Also known as: Copaxone

Glatiramer acetate

placebo DRUG

injected daily subcutaneously

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis)
• Current use of any approved disease modifying agents for treatment of MS
• Prior clinical episode of optic neuritis in either eye
• Bilateral AON
• Inability to undergo study evaluations in both eyes
• Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
• Retrogeniculate visual loss
• Refractive error of greater than +6 or -6 diopters
• Neuromyelitis Optica (Devic's disease)
• Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)
• Known ocular conditions that preclude dilation
• Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
• Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol
• Diabetes Mellitus Types I or II
• Gastric bypass surgery

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Optic Neuritis

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Enrollment did not meet expectations, and target sample sizes were not met.

Results Point of Contact

• Title: Scott Kolodny, M.D.
• Organization: Teva Pharmaceuticals, Medical Affairs

scott.kolodny@tevapharm.com

440-327-1811

Study Officials

• Mark J. Kupersmith, MD

  Roosevelt Hospital

  PRINCIPAL INVESTIGATOR

• Peter Calabresi, MD

  John Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 6, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: February 6, 2018
• Results First Posted: September 23, 2013

Record last verified: 2018-01