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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2013-000529-30-GB
• Date of registration: 17/10/2013
• Prospective Registration: Yes
• Primary sponsor: Walton Centre Foundation Trust
• Public title: prolonged-release oral fampridine in Neuromyelitis Optica (NMO), Pilot feasibility Study
• Scientific title: 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
• Date of first enrolment: 27/11/2013
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000529-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: David Johnson
• Affiliation: Biogen Idec International

• Name: David Johnson
• Affiliation: Biogen Idec International

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Neuromyelitis optica (NMO)

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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

Primary Outcome(s)

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 Objective: Secondary Objectives
Does Fampridine PR improve vision in NMO patients?

Main Objective: Does Fampridine-PR improve walking speed in a group of patients with ambulatory deficits due to Neuromyelitis Optica (NMO)?

Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 8 when stop taking fampridine
AND 2 weeks later

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

Source(s) of Monetary Support

Biogen Idec International

Ethics review

Status: Approved
Approval date:
Contact: