A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2021
• Main ID: NCT02208050
• Date of registration: 19/05/2014
• Prospective Registration: No
• Primary sponsor: University College Dublin
• Public title: A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS
• Scientific title: A Phase IV Double Blind, Randomized, Placebo Controlled, Crossover Study of the Effectiveness of Oral Fampridine in Improving Upper Limb Function in Progressive Multiple Sclerosis
• Date of first enrolment: February 21, 2014
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02208050
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Ireland

Contacts

• Name: Christopher McGuigan, MD
• Affiliation: University College Dublin, St Vincent's University Hospital

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: Fampridine

Primary Outcome(s)

Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) [Time Frame: 20 weeks. Baseline assessments 1,2,3: weeks 0-2. Assessment 4 - midway through first treatment period; assessment 5: end of first treatment period. Assessment 7: midway through second treatment period, assessment 8: end of second treatment period.]

Secondary Outcome(s)

Mean Scores in Multiple Sclerosis Walking Scale (MSWS-12) - Fampridine and Placebo. [Time Frame: 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period.]

The Number of Mobility Responders to Fampridine as Measured by an Improvement in the 25 Foot Timed Walk (T25FW) [Time Frame: 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8]

Mean Scores of MSIS-29 - Fampridine and Placebo [Time Frame: 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period.]

Mean Scores in DASH - Fampridine and Placebo. [Time Frame: 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period.]

Mean Scores in the Disabilities in Arm Function in Multiple Sclerosis Questionnaire (AMSQ) Score Between Fampridine and Placebo. [Time Frame: 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period.]

Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) [Time Frame: 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8]

Secondary ID(s)

SVUHneuro002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/07/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02208050