prolonged-release oral fampridine in Neuromyelitis Optica (NMO), Pilot feasibility Study

A pilot study to assess efficacy of prolonged-Release oral fampridine on ambulation and visual function in Neuromyelitis Optica - Assessment of fampridine-PR in NMO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000529-30-GB

Enrollment

Registered

2013-10-17

Start date

2013-11-27

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis optica (NMO)

Interventions

Trade Name: Fampyra Product Name: fampyra 10mg prolonged release tablets Pharmaceutical Form: Prolonged-release tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Clinically definite NMO or NMO spectrum disorder 18-70 years of age Able to complete the Timed 25 foot walk between 8-45 seconds at screening Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Pregnancy or breastfeeding History of seizure Renal impairment i.e. raised creatinine levels Onset of NMO exacerbation within 60 days prior to screening (i.e. unstable impairments) Increase in scheduled corticosteroid treatment during the study. Unable to walk 25 feet.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does Fampridine-PR improve walking speed in a group of patients with ambulatory deficits due to Neuromyelitis Optica (NMO)? ; Secondary Objective: Secondary Objectives Does Fampridine PR improve vision in NMO patients? ;Timepoint(s) of evaluation of this end point: 8 weeks; Primary end point(s): The primary outcome is the proportion of patients with consistent improvement in walking speed on the Timed 25ft walk during the treatment period (2)compared to Timed 25ft walk off treatment. The clinical meaningfulness of the response criterion is established by comparing 12-item MS walking scale (MSWS-12, a patient-reported assessment of walking disability,) pre and post study .	—

Measure

Time frame

Main Objective: Does Fampridine-PR improve walking speed in a group of patients with ambulatory deficits due to Neuromyelitis Optica (NMO)? ; Secondary Objective: Secondary Objectives Does Fampridine PR improve vision in NMO patients? ;Timepoint(s) of evaluation of this end point: 8 weeks; Primary end point(s): The primary outcome is the proportion of patients with consistent improvement in walking speed on the Timed 25ft walk during the treatment period (2)compared to Timed 25ft walk off treatment. The clinical meaningfulness of the response criterion is established by comparing 12-item MS walking scale (MSWS-12, a patient-reported assessment of walking disability,) pre and post study .

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome is the proportion of patients with consistent improvement in their visual acuity, and colour vision as assessed by snellen and Ishihara will be completed. Also improvement shown by VERs pre and post taking fampridine-PR ; Timepoint(s) of evaluation of this end point: Week 8 when stop taking fampridine AND 2 weeks later	—

Countries

United Kingdom

Contacts

Public ContactDavid Johnson

Biogen Idec International

david.johnson@biobeniec.com07702951907

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026