Optic NeuritisPhase 3NCT00856635

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 Phase 3 study testing Glatiramer Acetate in people with Optic Neuritis, run by Teva Branded Pharmaceutical Products R&D, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Optic Neuritis
What is being tested?: Glatiramer Acetate
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: No sites listed yet
Study dates: Feb 2009to Feb 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 20Show fewer

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
Current use of chemotherapy or radiotherapy
Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (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 patient's ability to give informed consent or to complete the study procedures
Use of an investigational drug within 30 days prior to randomization

About this study

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)

Conditions: Optic Neuritis
Being tested: Glatiramer Acetate, placebo
Medical subject headings: Optic Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glatiramer AcetateDrug
Also called Copaxone
20 mg injected daily subcutaneously
placeboDrug
injected daily subcutaneously

Study groups in NCT00856635
Study group	Role	What they receive
Glatiramer acetate	Experimental	Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months. Receives: Drug: Glatiramer Acetate
Placebo	Placebo comparator	Participants received placebo subcutaneous injection once a day for up to 6 months. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Month 6

Secondary outcomes (1)

To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Feb 2011

First posted6 Mar 2009 (estimated)
Study startFeb 2009
Primary completionDec 2010
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Optic NeuritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00856635
Sponsor's protocol ID: PM030
Status last verified: Jan 2018
First submitted: 4 Mar 2009
Last updated: 6 Feb 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
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Biobank For MS And Other Demyelinating Diseases
Multiple Sclerosis, Transverse Myelitis
RecruitingObservational study
Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected
Optic Neuritis, Optic Neuropathy
RecruitingPhase 3
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
Optic Neuritis, Myelitis
RecruitingPhase 3
Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research
Optic Neuritis

All Optic Neuritis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00856635
Acronym / sponsor ID: PM030
Conditions: Optic Neuritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Dec 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 6 Mar 2009 (estimated)
Results: Posted 23 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Glatiramer acetate	Experimental	Drug: Glatiramer AcetateParticipants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Placebo	Placebo comparator	Drug: placeboParticipants received placebo subcutaneous injection once a day for up to 6 months.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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:

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Glatiramer AcetateAlso: Copaxone20 mg injected daily subcutaneously	Drug	Glatiramer acetate
placeboinjected daily subcutaneously	Drug	Placebo

Primary outcome

Retinal Nerve Fiber Layer Thickness at Baseline and Month 6
Time frame: 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.

1 secondary outcome

To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.
Time frame: 6 months

Results and safety

Results posted to the registry on 23 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glatiramer Acetate	22	12
Placebo	22	14

Primary outcome: Retinal Nerve Fiber Layer Thickness at Baseline and Month 6

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: µm

Measure	Glatiramer Acetate n = 18	Placebo n = 18
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)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glatiramer Acetate	1 of 20 (5%)	0 of 20 (0%)	Not reported
Placebo	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): Enrollment did not meet expectations, and target sample sizes were not met.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Optic Neuritis

RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingObservational study
Biobank For MS And Other Demyelinating Diseases
Multiple Sclerosis, Transverse Myelitis
RecruitingObservational study
Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected
Optic Neuritis, Optic Neuropathy
RecruitingPhase 3
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
Optic Neuritis, Myelitis
RecruitingPhase 3
Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research
Optic Neuritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark J. Kupersmith, MD principal investigator

Roosevelt Hospital

Peter Calabresi, MD principal investigator

John Hopkins School of Medicine

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glatiramer Acetate in people with Optic Neuritis, run by Teva Branded Pharmaceutical Products R&D, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.