Trial on the effectiveness of Fampridine medication for upper limb function in people with MS.

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 14.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002561-38-IE
• Lead Sponsor: St. Vincent's University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-09
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients with SPMS or PPMS, aged 18-70, who have Kurtzke EDSS scores in the range 4.0 to 7.0 inclusive and a walking speed with or without aids in the T25FW of 8.0 to 14.0 seconds and evidence of significant upper limb dysfunction as defined by a 9HPT of 15 – 90 seconds (dominant or non-dominant hand), will be recruited.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Patients with a history of seizures, significant liver dysfunction, significant renal dysfunction, significant upper or lower limb arthritis or any other disorder including cognitive dysfunction which would affect the ability to accurately complete questionnaires and give full informed consent.
2) Patients with clinically significant upper limb ataxia or upper limb proprioceptive sensory loss, which in the opinion of the Clinician affect upper limb functional assessment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified