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Clinical Trials/EUCTR2013-000529-30-GB
EUCTR2013-000529-30-GB
Active, not recruiting
Phase 1

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

Walton Centre Foundation Trust0 sites20 target enrollmentOctober 17, 2013
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Conditionseuromyelitis optica (NMO)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsFampyra

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
euromyelitis optica (NMO)
Sponsor
Walton Centre Foundation Trust
Enrollment
20
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Walton Centre Foundation Trust

Eligibility 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.

Outcomes

Primary Outcomes

Not specified

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