Optic NeuritisPhase 2NCT02939937

Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis

A Phase 2 study testing Phenytoin in people with Optic Neuritis, run by Tehran University of Medical Sciences at 1 site in Iran.

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

Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days. As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Optic Neuritis
What is being tested?: Phenytoin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 1 siteIran
Study dates: 9 Mar 2017to 2 Jan 2019
Phase: Phase 2
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)
willing to receive a steroidal regimen
no pathologic finding in first oct
no pathology and history of optic neuritis in contralateral eye
<14 days since onset visual loss

Who cannot join

Contraindication or known allergy to Phenytoin
Use of a calcium channel or sodium channel blocker in the past 2 months
Corticosteroid use in the past 2 months
Pregnancy
Significant cardiac, renal or liver abnormalities
Prior clinical episode of optic neuritis in either eye

Show all 10Show fewer

Bilateral acute optic neuritis
Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
Refractive error of greater than +5 or -5 diopters
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

Trial locations and contacts

1 site in 1 country.

Iran1 site

Eye Research Center Farabi Hosoital
Tehran, 3542168325

Other trials in Iran

About this study

Official title: a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) Thickness and Visual Field in Patients With a First Episode of Acute Optic Neuritis

Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days.

As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision.

There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage.

The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.

Conditions: Optic Neuritis
Being tested: Phenytoin, 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.

PhenytoinDrug
Also called epanutin
100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
placeboDrug
100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.

Study groups in NCT02939937
Study group	Role	What they receive
phenytoin	Experimental	patients received phenytoin 100mg three time daily up to 3 months Receives: Drug: Phenytoin
placebo	Experimental	patients received placebo 100 mg three time daily for 3 months Receives: Drug: placebo

What is being measured

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

Retinal Ganglion Cell Inner Plexiform Layer Thickness
ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Measured: Measured at baseline and month 1, 6
Macular Layer Thickness
macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
Measured: Measured at baseline and month 1, 6
Best Corrected Visual Acuity
Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
Measured: at baseline and month 6
Visual Field Mean Deviation in Decibel
The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).
Measured: Measured at baseline and month 6

Secondary outcomes (1)

Retinal Nerve Fibre Layer Thickness in Micrometer
Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Measured: Measured at baseline and month1 ,6

Timeline

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

9 Mar 20172 Jan 2019

First posted20 Oct 2016 (estimated)
Study start9 Mar 2017
Primary completion11 Nov 2018
Study completion2 Jan 2019

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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02939937
Sponsor's protocol ID: 9411257013
Status last verified: Apr 2018
First submitted: 8 Aug 2016
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

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?

See locations

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All Optic Neuritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) Thickness and Visual Field in Patients With a First Episode of Acute Optic Neuritis
ClinicalTrials.gov ID: NCT02939937
Acronym / sponsor ID: 9411257013
Conditions: Optic Neuritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Tehran University of Medical SciencesUniversity, hospital or other
Study start: 9 Mar 2017 (actual)
Primary completion: 11 Nov 2018 (actual)
Study completion: 2 Jan 2019 (actual)
First posted: 20 Oct 2016 (estimated)
Results: Posted 12 Aug 2019

Clinical summary

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

Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days.

As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision.

There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage.

The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
phenytoin	Experimental	Drug: Phenytoinpatients received phenytoin 100mg three time daily up to 3 months
placebo	Experimental	Drug: placebopatients received placebo 100 mg three time daily for 3 months

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)
willing to receive a steroidal regimen
no pathologic finding in first oct
no pathology and history of optic neuritis in contralateral eye
<14 days since onset visual loss

Key exclusion criteria (10 listed)

Contraindication or known allergy to Phenytoin
Use of a calcium channel or sodium channel blocker in the past 2 months
Corticosteroid use in the past 2 months
Pregnancy
Significant cardiac, renal or liver abnormalities

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
PhenytoinAlso: epanutin100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.	Drug	phenytoin
placebo100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.	Drug	placebo

Primary outcome

Retinal Ganglion Cell Inner Plexiform Layer Thickness
Time frame: Measured at baseline and month 1, 6
ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Macular Layer Thickness
Time frame: Measured at baseline and month 1, 6
macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
Best Corrected Visual Acuity
Time frame: at baseline and month 6
Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
Visual Field Mean Deviation in Decibel
Time frame: Measured at baseline and month 6
The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).

1 secondary outcome

Retinal Nerve Fibre Layer Thickness in Micrometer
Time frame: Measured at baseline and month1 ,6

Results and safety

Results posted to the registry on 12 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phenytoin	21	15
Placebo	50	47

Primary outcome: Retinal Ganglion Cell Inner Plexiform Layer Thickness

Time frame: Measured at baseline and month 1, 6. Mean (Standard Deviation). Unit: micron

Measure	Phenytoin n = 15	Placebo n = 47
baseline	36.56 (6.61)	34.65 (8.49)
1 month	31 (6.61)	29.42 (5.98)
6 months	30.70 (5.56)	32.12 (9.10)

Population analysed: incomplete follow up from baseline to 6 month

Primary outcome: Macular Layer Thickness

Time frame: Measured at baseline and month 1, 6. Mean (Standard Deviation). Unit: micron

Measure	Phenytoin n = 15	Placebo n = 47
baseline	262.73 (22.02)	265.98 (22.5)
1 month	255 (19.72)	264.39 (22.53)
6 months	269 (28.29)	268.37 (22.69)

Population analysed: incomplete follow up

Primary outcome: Best Corrected Visual Acuity

Time frame: at baseline and month 6. Mean (Standard Deviation). Unit: log mar

Measure	Phenytoin n = 15	Placebo n = 47
baseline	1.44 (0.98)	1 (0.83)
6 months	0.04 (0.067)	0.13 (0.448)

Population analysed: incomplete follow up

Primary outcome: Visual Field Mean Deviation in Decibel

Time frame: Measured at baseline and month 6. Mean (Standard Deviation). Unit: db

Measure	Phenytoin n = 15	Placebo n = 47
Baseline visual field mean deviation (MD)	-17.07 (11.41)	-17.76 (11.81)
6 months MD	-3.89 (4.46)	-5.16 (7.49)

Population analysed: incomplete follow up

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phenytoin	1 of 21 (4.8%)	4 of 21 (19%)	0 of 21
Placebo	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): 1. Shorter follow up 2. Poor compliance for oral drug intake

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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Recruiting
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Neuromyelitis Optica Spectrum Disorder (NMOSD)
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Phenytoin in people with Optic Neuritis, run by Tehran University of Medical Sciences at 1 site in Iran.

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 5 inclusion and 10 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 12 Aug 2019). 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 Ganglion Cell Inner Plexiform Layer Thickness (time frame: Measured at baseline and month 1, 6). The study lists 4 primary outcomes in all. 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 NCT02939937.

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 12 Aug 2019.