Role of Dalfampridine in optic neuritis
- Conditions
- Health Condition 1: G379- Demyelinating disease of central nervous system, unspecified
- Registration Number
- CTRI/2021/07/034725
- Lead Sponsor
- Department of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Clinical diagnosis of acute unilateral demyelinating optic neuritis
2.Visual acuity of 6/9 or less
3.Within 14 days of onset of symptoms
4.Willing to give consent
1.Infective optic neuritis
2.Previous history of optic neuritis in either eye if vision not recovered fully to baseline before the current episode.
3. Clinical/biochemical evidence of hepatic/renal/cardiac dysfunction
4. Concurrent ocular disease
5. Patient already on concomitant immune therapies (except glatarimer acetate and interferon beta) in the 2 months preceding treatment
6.Seropositivity for Aquaporin-4 antibody
7. Past history of seizures, prolonged QTc or renal insufficiency (contraindications to dalfampridine)
8.Women of childbearing potential who are not using adequate contraception or who are pregnant/lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of visual acuity and colour vision at 1 monthTimepoint: Baseline, 1st month, 2nd month, 3rd month, 4th month, 5th month and 6th month
- Secondary Outcome Measures
Name Time Method 1.Contrast sensitivity <br/ ><br>2.Visual field <br/ ><br>3.Mean reduction in RNFL and GCPL in affected eye at 3 and 6 months compared with unaffected eye at baseline <br/ ><br>4.Optic nerve cross-sectional area <br/ ><br>5.Optic nerve lesion length <br/ ><br>6. Latency and amplitude of visual evoked potentials <br/ ><br>7. Adverse effectTimepoint: At baseline, 3rd month and 6th month.Optic nerve cross-sectional area and lesion length will be done only at baseline and 6th month.