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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)

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ClinicalTrials.gov Identifier: NCT00856635
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : September 23, 2013
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Optic Neuritis
Interventions Drug: Glatiramer Acetate
Drug: placebo
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glatiramer Acetate Placebo
Hide Arm/Group Description Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months. Participants received placebo subcutaneous injection once a day for up to 6 months.
Period Title: Overall Study
Started 22 22
Received Study Drug 20 20
Completed 12 14
Not Completed 10 8
Reason Not Completed
Lost to Follow-up             2             5
Pregnancy             1             0
Withdrawal by Subject             3             1
Serious Adverse Event             1             0
Other             1             0
Discontinued at Randomization             2             2
Arm/Group Title Glatiramer Acetate Placebo Total
Hide Arm/Group Description Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months. Participants received placebo subcutaneous injection once a day for up to 6 months. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
The safety analysis set included all patients who had been randomized to the study and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
31.7  (7.1) 34.4  (6.5) 33.0  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
13
  65.0%
15
  75.0%
28
  70.0%
Male
7
  35.0%
5
  25.0%
12
  30.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Asian 2 0 2
Caucasian 13 15 28
Black/African American 1 3 4
Hispanic 3 1 4
Other 1 1 2
1.Primary Outcome
Title Retinal Nerve Fiber Layer Thickness at Baseline and Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glatiramer Acetate Placebo
Hide Arm/Group Description:
Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Participants received placebo subcutaneous injection once a day for up to 6 months.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: µm
Baseline (n=18, 18) 128.1  (11.9) 130.5  (8.9)
Month 6 (n=13, 13) 89.5  (8.9) 88.0  (5.5)
2.Secondary Outcome
Title To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glatiramer Acetate Placebo
Hide Arm/Group Description:

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

Glatiramer Acetate: 20 mg injected daily subcutaneously

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

placebo: injected daily subcutaneously

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glatiramer Acetate Placebo
Hide Arm/Group Description Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months. Participants received placebo subcutaneous injection once a day for up to 6 months.
All-Cause Mortality
Glatiramer Acetate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Glatiramer Acetate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   0/20 (0.00%) 
Immune system disorders     
Drug Hypersensitivity   1/20 (5.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glatiramer Acetate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Enrollment did not meet expectations, and target sample sizes were not met.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Kolodny, M.D.
Organization: Teva Pharmaceuticals, Medical Affairs
Phone: 440-327-1811
EMail: scott.kolodny@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00856635     History of Changes
Other Study ID Numbers: PM030
First Submitted: March 4, 2009
First Posted: March 6, 2009
Results First Submitted: July 11, 2013
Results First Posted: September 23, 2013
Last Update Posted: February 6, 2018