Trials / Unknown
UnknownNCT04148781
Fampridine-SR and Optic Neuritis Recovery
The Effect of Fampridine-SR on Visual Function in Poorly Recovered Optic Neuritis in Persons With MS
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Courtney Casserly · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fampridine SR | Fampridine-SR 10 mg twice daily for 8 weeks |
Timeline
- Start date
- 2022-03-22
- Primary completion
- 2023-12-01
- Completion
- 2024-01-01
- First posted
- 2019-11-04
- Last updated
- 2022-08-25
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04148781. Inclusion in this directory is not an endorsement.