Optic NeuritisEarly Phase 1FAMP-ONNCT04148781
Fampridine-SR and Optic Neuritis Recovery
A Early Phase 1 study testing Fampridine SR in people with Optic Neuritis, run by Courtney Casserly at 1 site in Canada.
Trial summary
Optic Neuritis (ON) is a condition that occurs in approximately 50% of individuals with relapse remitting MS, and is the presenting event in 15-20% of patients who go on to develop MS. These ON events present with a decline in vision over several days with painful eye movements. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Fampridine SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 22 Mar 2022to Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have an MS diagnosis, any type
- Had an acute optic neuritis without full recovery which occurred ≥ one year ago
- Have a visual acuity in the affected of eye of ≥ 20/40 or
- Or ≥20 ms difference in VEP between eyes
- Or ≥ 120 ms VEP in the affected eye
- Have not received corticosteroids in the last thirty (30) days
Show all 11Show fewer
- Medications that could potentially affect the VEP P100 amplitude or may cause drowsiness/difficulty with visual fixation are allowed if there has been no change in dose within 30 days of study enrollment or anytime during the study. These medications include:
- Benzodiazepines other than every night at bedtime
- Opioid and opiates other than every night at bedtime
- Cannabinoid products other than every night at bedtime
- Have given written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care
Who cannot join
- Have another medical condition that could affect the visual outcomes, such as, but not limited to, diabetes retinopathy, glaucoma, cataracts, previous ocular trauma, amblyopia, and optic neuropathy not due to a demyelinating lesion
- Creatinine clearance ≤ 80 mL/min
- Has a history of seizures, with the exception of febrile seizure as an infant
- Taking a medicinal product that is an inhibitor of Organic Cation Transporter 2 (OCT-2)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Heather Rosehart, BSc, 519-685-8500 ext. 34706, heather.rosehart@lhsc.on.ca
Riya Dhillon, BA, 519-685-8500 ext. 37803, riya.dhillon@lhsc.on.ca
About this study
Official title: The Effect of Fampridine-SR on Visual Function in Poorly Recovered Optic Neuritis in Persons With MS
Optic Neuritis (ON) is a condition that occurs in approximately 50% of individuals with relapse remitting MS, and is the presenting event in 15-20% of patients who go on to develop MS. These ON events present with a decline in vision over several days with painful eye movements. The purpose of this study is to collect pilot data on the effect of Fampridine-SR on the recovery of visual function after demyelinating optic neuritis.Our team evaluated a person with ON who had incomplete recovery which was quite bothersome to her. After a one-month treatment course Fampridine SR,her visual functioning improved. Based on this case, we present a unique opportunity to evaluate the potential benefit of Fampridine-SR as a potential treatment for persons who do not fully recover from acute ON.
Read the detailed description
Optic Neuritis (ON) is a condition that occurs in approximately 50% of individuals with relapse remitting MS, and is the presenting event in 15-20% of patients who go on to develop MS. ON usually presents with a decline in vision over several days to weeks with painful eye movements.
Fampridine-SR is currently a Health Canada approved medication to treat walking impairment in persons with MS. Some small studies in the past have shown that Fampridine-SR may also have positive effects on visual functioning in those experiencing ON.
This study will aim to assess the effect of taking Fampridine-SR for 8 weeks in 20 MS patients with unresolved optic neuritis on measures of visual functioning, and to determine the best measures to use in a future large scale study. The results of this study will also be used to estimate how many participants we will need in the future large scale study.
- Conditions
- Optic Neuritis
- Being tested
- Fampridine SR
- Keywords
- Multiple sclerosis, Optic Neuritis, Fampyra
- Medical subject headings
- Optic Neuritis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fampridine SRDrug
Fampridine-SR 10 mg twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fampridine-SR | Experimental | Fampridine-SR 10 mg Orally Twice Daily for 8 weeks. Receives: Drug: Fampridine SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Evoked Potentials
Visual evoked potentials (VEPs) measure the occipital cortical response to visual stimuli and are used to detect visual abnormalities. VEPs will be measured at multiple time points to assess any changes in VEPs over the duration of the study.
Measured: Measured at baseline, week 8, and week 12
Change in Visual Acuity
Change in visual acuity will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts and standard protocol as it the gold standard for ophthalmology clinical trials using visual acuity as an outcome. Visual acuity will be measured at multiple time points to assess any changes over the duration of the study.
Measured: Measured at baseline, week 8, and week 12
Change in Contrast Sensitivity
Contrast sensitivity or low contrast visual acuity (LCVA) has been found to be a sensitive measure of visual function in demyelinating lesions when focusing on recovery, even in patients with high contrast visual acuity. Contrast sensitivity will be measured at multiple time points to assess any changes over the duration of the study.
Measured: Measured at baseline, week 8, and week 12
Change in Colour Vision
Colour vision is frequently affected in optic neuritis and unlikely to fully recover We will use Ishihara colour plates, a common test to assess colour vision. Colour vision will be measured at multiple time points to assess any changes over the duration of the study.
Measured: Measured at baseline, week 8, and week 12
Change in Visual Fields
Measures of central visual function are important in the evaluation of optic neuritis, because most cases of optic neuritis affect central vision and therefore decrease quality of life. Visual fields will be measured at multiple time points to assess any changes over the duration of the study.
Measured: Measured at baseline, week 8, and week 12
Optical Coherence Tomography
Optical coherence tomography (OCT) is now a ubiquitous technology in the world of MS research, and is an excellent means of imaging the layers of the retina.
Measured: Measured at baseline.
Change in 10-Item Neuro-Ophthalmic Supplement total scores
The 10-Item Neuro-Ophthalmic Supplement (NOS-10) has been developed to capture patient-reported outcomes related to visual dysfunction in patients with visual disorders. Total scores will be collected (range 1 to 52). Scores on the NOS-10 will be measured at multiple time points to assess any changes over the duration of the study.
Measured: Measured at baseline, week 8, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start22 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Courtney Casserly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Courtney Casserly, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148781
- Sponsor's protocol ID
- 113427
- Acronym
- FAMP-ON
- Status last verified
- Aug 2022
- First submitted
- 11 Sep 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fampridine-SR on Visual Function in Poorly Recovered Optic Neuritis in Persons With MS
- ClinicalTrials.gov ID
- NCT04148781
- Acronym / sponsor ID
- FAMP-ON / 113427
- Conditions
- Optic Neuritis
- Keywords
- Multiple sclerosis, Optic Neuritis, Fampyra
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Courtney CasserlyUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optic Neuritis (ON) is a condition that occurs in approximately 50% of individuals with relapse remitting MS, and is the presenting event in 15-20% of patients who go on to develop MS. These ON events present with a decline in vision over several days with painful eye movements. The purpose of this study is to collect pilot data on the effect of Fampridine-SR on the recovery of visual function after demyelinating optic neuritis.Our team evaluated a person with ON who had incomplete recovery which was quite bothersome to her. After a one-month treatment course Fampridine SR,her visual functioning improved. Based on this case, we present a unique opportunity to evaluate the potential benefit of Fampridine-SR as a potential treatment for persons who do not fully recover from acute ON.
Detailed description
Optic Neuritis (ON) is a condition that occurs in approximately 50% of individuals with relapse remitting MS, and is the presenting event in 15-20% of patients who go on to develop MS. ON usually presents with a decline in vision over several days to weeks with painful eye movements.
Fampridine-SR is currently a Health Canada approved medication to treat walking impairment in persons with MS. Some small studies in the past have shown that Fampridine-SR may also have positive effects on visual functioning in those experiencing ON.
This study will aim to assess the effect of taking Fampridine-SR for 8 weeks in 20 MS patients with unresolved optic neuritis on measures of visual functioning, and to determine the best measures to use in a future large scale study. The results of this study will also be used to estimate how many participants we will need in the future large scale study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fampridine-SR | Experimental | Drug: Fampridine SRFampridine-SR 10 mg Orally Twice Daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Have an MS diagnosis, any type
- Had an acute optic neuritis without full recovery which occurred ≥ one year ago
- Have a visual acuity in the affected of eye of ≥ 20/40 or
- Have not received corticosteroids in the last thirty (30) days
- Medications that could potentially affect the VEP P100 amplitude or may cause drowsiness/difficulty with visual fixation are allowed if there has been no change in dose within 30 days of study enrollment or anytime during the study. These medications include:
Key exclusion criteria (4 listed)
- Have another medical condition that could affect the visual outcomes, such as, but not limited to, diabetes retinopathy, glaucoma, cataracts, previous ocular trauma, amblyopia, and optic neuropathy not due to a demyelinating lesion
- Creatinine clearance ≤ 80 mL/min
- Has a history of seizures, with the exception of febrile seizure as an infant
- Taking a medicinal product that is an inhibitor of Organic Cation Transporter 2 (OCT-2)
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 |
|---|---|---|
| Fampridine SRFampridine-SR 10 mg twice daily for 8 weeks | Drug | Fampridine-SR |
Primary outcome
Change in Visual Evoked Potentials
Time frame: Measured at baseline, week 8, and week 12
Visual evoked potentials (VEPs) measure the occipital cortical response to visual stimuli and are used to detect visual abnormalities. VEPs will be measured at multiple time points to assess any changes in VEPs over the duration of the study.
Change in Visual Acuity
Time frame: Measured at baseline, week 8, and week 12
Change in visual acuity will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts and standard protocol as it the gold standard for ophthalmology clinical trials using visual acuity as an outcome. Visual acuity will be measured at multiple time points to assess any changes over the duration of the study.
Change in Contrast Sensitivity
Time frame: Measured at baseline, week 8, and week 12
Contrast sensitivity or low contrast visual acuity (LCVA) has been found to be a sensitive measure of visual function in demyelinating lesions when focusing on recovery, even in patients with high contrast visual acuity. Contrast sensitivity will be measured at multiple time points to assess any changes over the duration of the study.
Change in Colour Vision
Time frame: Measured at baseline, week 8, and week 12
Colour vision is frequently affected in optic neuritis and unlikely to fully recover We will use Ishihara colour plates, a common test to assess colour vision. Colour vision will be measured at multiple time points to assess any changes over the duration of the study.
Change in Visual Fields
Time frame: Measured at baseline, week 8, and week 12
Measures of central visual function are important in the evaluation of optic neuritis, because most cases of optic neuritis affect central vision and therefore decrease quality of life. Visual fields will be measured at multiple time points to assess any changes over the duration of the study.
Optical Coherence Tomography
Time frame: Measured at baseline.
Optical coherence tomography (OCT) is now a ubiquitous technology in the world of MS research, and is an excellent means of imaging the layers of the retina.
Change in 10-Item Neuro-Ophthalmic Supplement total scores
Time frame: Measured at baseline, week 8, and week 12
The 10-Item Neuro-Ophthalmic Supplement (NOS-10) has been developed to capture patient-reported outcomes related to visual dysfunction in patients with visual disorders. Total scores will be collected (range 1 to 52). Scores on the NOS-10 will be measured at multiple time points to assess any changes over the duration of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fampridine SR in people with Optic Neuritis, run by Courtney Casserly at 1 site in Canada.
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 11 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2022. 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 Canada. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Rosehart, BSc (519-685-8500 ext. 34706, heather.rosehart@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Evoked Potentials (time frame: Measured at baseline, week 8, and week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2022.