Health Condition 1: G379- Demyelinating disease of central nervous system, unspecified
Conditions
Interventions
Intervention1: Dalfampridine: 10 mg BD for 3 months, per oral route
Control Intervention1: Placebo: BD dosing for 3 months, per oral route
Sponsors
Department of Health Research
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.Contrast sensitivity 2.Visual field 3.Mean reduction in RNFL and GCPL in affected eye at 3 and 6 months compared with unaffected eye at baseline 4.Optic nerve cross-sectional area 5.Optic nerve lesion length 6. Latency and amplitude of visual evoked potentials 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. | — |
Countries
India
Contacts
Public ContactDr Animesh Das
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed