prolonged-release oral fampridine in Neuromyelitis Optica (NMO), Pilot feasibility Study
Phase 1
- Conditions
- euromyelitis optica (NMO)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-000529-30-GB
- Lead Sponsor
- Walton Centre Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method