Phase 4
N=64
A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS
Secondary Progressive Multiple Sclerosis · Primary Progressive Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02208050 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) — 4; 3; 58; 59 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fampridine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University College Dublin
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) |
4; 3; 58; 59; 2; 1 | — |
| SECONDARY Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) |
3; 0; 60; 61; 3; 0 | — |
| SECONDARY The Number of Mobility Responders to Fampridine as Measured by an Improvement in the 25 Foot Timed Walk (T25FW) |
59; 59; 2; 2 | — |
| SECONDARY Mean Scores in DASH - Fampridine and Placebo. |
35.4; 38.3 | — |
| SECONDARY Mean Scores in Multiple Sclerosis Walking Scale (MSWS-12) - Fampridine and Placebo. |
64.5; 65 | — |
| SECONDARY Mean Scores in the Disabilities in Arm Function in Multiple Sclerosis Questionnaire (AMSQ) Score Between Fampridine and Placebo. |
35.4; 38.4 | — |
| SECONDARY Mean Scores of MSIS-29 - Fampridine and Placebo |
42.4; 43.3; 30.5; 29.4 | — |
Summary
The purpose of this study is to examine the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT).
Fampridine has been shown to be effective in improving motor function, specifically walking ability in prior studies in this patient population and is currently licensed for this use in Europe and the United States. Upper limb dysfunction is common in SPMS and PPMS and often underestimated. Fampridine effects action potential conduction in demyelinated nerve fibres and we would hypothesise that the improvement previously reported in walking ability would be similar to that on upper limb dysfunction. Our study aims to address this question using both independent and patient reported outcomes in the context of a randomised placebo controlled crossover trial.
Eligibility Criteria
Inclusion Criteria
- Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
- Subjects must be diagnosed with clinically definite SPMS or PPMS and be judged to be in generally good health by the investigator based upon the results of the medical history, laboratory tests (liver and renal function), physical examination, 12-lead electrocardiogram performed during Screening
- Subjects must be Male or female aged 18-70 at baseline
- Kurtzke EDSS scores in the range 4.0 to 7.0 inclusive
- Evidence of significant upper limb dysfunction as defined by a 9HPT of 15 - 90 seconds (dominant or non-dominant hand)
- Female subjects with reproductive capabilities must have a negative serum pregnancy test at baseline and agree to using an acceptable form of contraception for the duration of the study (barrier, coil or oral contraceptives only).
Exclusion Criteria
- Allergy/sensitivity to study medications or their ingredients
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- Subjects unable to provide written informed consent
- Subjects with a history of epilepsy or previous seizures (including provoked seizures).
- Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Subjects with an AST or ALT ≥ 3 x ULN on liver function tests
- Subjects have clinically significant ECG findings as judged by the investigator, in particular evidence of a cardiac conduction defect.
- Significant upper or lower limb arthritis as considered by the investigator to interfere with study assessments.
- Significant cognitive impairment as considered by the investigator to interfere with study assessments
- Subjects with clinically significant upper limb ataxia considered by the investigator to interfere with ability to complete study outcome measures.
- Patients with mild, moderate or severe renal impairment (creatinine clearance<80ml/min) measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula
- Subjects concomitantly using medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example cimetidine
- Concurrent treatment with other medicinal products containing fampridine (4- aminopyridine)
Data sourced from ClinicalTrials.gov (NCT02208050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.