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)

This study has been completed.

First Received on March 4, 2009. Last Updated on August 22, 2011 History of Changes

Sponsor:	Teva Pharmaceutical Industries
Information provided by (Responsible Party):	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00856635

Purpose

The main objective of the study is to determine whether GA 20mg SC once daily reduces the amount of axonal loss in the optic nerve (measured by RFNL thickness) after a first event of AON compared to placebo patients and to generate data supporting the potential neuroprotective effect of GA in a human in vivo model of axonal loss..

Condition	Intervention	Phase
Optic Neuritis	Drug: Glatiramer Acetate (Copaxone) Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fiber

Drug Information available for: Copolymer 1

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Change in the mean RNFL (all sectors) in the affected eye from 0-6 months, in the Glatiramer Acetate vs. placebo assessed as the outcome RNFL adjusted for the baseline RNFL of the unaffected eye. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate changes on additional OCT parameters and other visual function and clinical parameters. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	42
Study Start Date:	February 2009
Study Completion Date:	February 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Glatiramer Acetate (Copaxone) 20mg injected daily subcutaneously	Drug: Glatiramer Acetate (Copaxone) 20mg injected daily subcutaneously
Placebo Comparator: 2 Placebo injected daily subcutaneously	Drug: placebo injected daily subcutaneously

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age: 18 - 45 years
Isolated, unilateral, first 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

Exclusion Criteria:

A diagnosis of clinically definite MS (CDMS)
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, SLE, Wegener's Granulomatosis, Syphilis, HIV
Known ocular conditions that preclude dilation
Any condition that may interfere with performance of 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
Current use of chemotherapy or radiotherapy
Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, IFN-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine
Ongoing treatment with steroids (for longer than 10 days) within the last 3 months
Significant or unstable medical, systemic, psychiatric or logistical condition that affects the subject's ability to give informed consent or to complete the study procedures
Use of an investigational drug within 30 days prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856635

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Principal Investigator:	Mark J. Kupersmith, MD	Roosevelt Hospital
Principal Investigator:	Peter Calabresi, MD	John Hopkins School of Medicine

More Information

No publications provided

Responsible Party:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00856635 History of Changes
Other Study ID Numbers:	PM030
Study First Received:	March 4, 2009
Last Updated:	August 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases

Eye Diseases
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012