Study to evaluate the effects of fampridine in patients with multiple sclerosis and eye movement abnormality

• Conditions: Multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-000182-31-NL
• Lead Sponsor: CHDR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-26
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male and female patients 18 years or more of age;
2. Diagnosis of multiple sclerosis according to the revised McDonald criteria (Appendix A);
3. A disease duration > 1 year as defined by a diagnosis of MS at least one year prior to inclusion in the study;
4. Clinically stable disease > 30 days;
5. Subject shows evidence of INO for at least 30 days by quantitative neuro-ophthalmological criteria;
6. Subject is able to understand the demands of the protocol, has had any questions answered and has voluntarily signed the informed consent prior to any study procedures; and
7. Subject is otherwise in good health, based on complete medical history and physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Subject is a pregnant female (as determined by a urine pregnancy test), a lactating female, or a female of child-bearing potential, not sterilized and not using one of the following methods of birth control: oral or injectable contraceptive agent, implantable contraceptive device, or barrier method;
2. The neuro-ophthalmological examination demonstrates significant impairment of eye-movements due to cerebellar or other pathology which may infer with reliable testing of an INO;
3. Inability of a subject to maintain good visual fixation;
4. Subject has a prior history or current presentation of seizure;
5. Subject has a creatinine clearance less than 80 mL/min, calculated by Cocroft-Gault equation;
6. Subject has known allergy to fampridine;
7. Subject has any contraindication of MRI;
8. The subject has any medical condition, including psychiatric disease that might interfere with the interpretation of the results or with the conduct of the study;
9. Subject has a history of drug or ethanol abuse within the past year;
10. A positive urine drug screen;
11. Subject has a history of ischemic heart disease;
12. Concomitant use of fampridine with medicinal products that are inhibitors or substrates of organic cation transporter 2 (OCT2) such as cimetidine, carvedilol, propanolol and metformin;
13. Treatment with another investigational drug within 3 months prior to screening or having participated in more than 4 investigational drug studies within 1 year prior to screening; and/or
14. The subject has abnormal clinical laboratory values or an abnormal ECG, without approval of the study investigator.

Study & Design

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