Text Size

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.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00856635
First received: March 4, 2009
Last updated: August 22, 2011
Last verified: August 2011
History of Changes

March 4, 2009
August 22, 2011
February 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00856635 on ClinicalTrials.gov Archive Site
To evaluate changes on additional OCT parameters and other visual function and clinical parameters. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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)
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)

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..
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Optic Neuritis
  • Drug: Glatiramer Acetate (Copaxone)
    20mg injected daily subcutaneously
  • Drug: placebo
    injected daily subcutaneously
  • Experimental: 1
    Glatiramer Acetate (Copaxone) 20mg injected daily subcutaneously
    Intervention: Drug: Glatiramer Acetate (Copaxone)
  • Placebo Comparator: 2
    Placebo injected daily subcutaneously
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00856635
PM030
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Principal Investigator: Mark J. Kupersmith, MD Roosevelt Hospital
Principal Investigator: Peter Calabresi, MD John Hopkins School of Medicine
Teva Pharmaceutical Industries
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP