multiple sclerosis nerve disease
Conditions
Interventions
Fampridine 20 mg, once during the study.
Internuclear Ophthalmoplegia
Multiple Sclerosis
nerve conduction
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients 18 years or more of age; 2. Diagnosis of multiple sclerosis according to the revised McDonald (2005) criteria; 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 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.
Exclusion criteria
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 Cockroft-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eye movements at each day and time point. Variables will include (but not limit to): - eye position and velocity at the abducting/adducting eye -Versional disconjugacy index: the inter-ocular ratio of the peak velocity and peak acceleration of the abducting and adducting eye. -first-pass amplitude: the ratio of the position of the abducting eye to the adducting eye when both eyes reached their final position of ocular displacement with respect to the target position. - peak velocity ratio for each saccade - saccade pulse in the 2 eyes | — |
Secondary
| Measure | Time frame |
|---|---|
| A MRI-scan brain: - signal intensity MLF - length of MLF Nerve conduction speed as determined by lag time of the adducting eye divided by the length of the MLF Cognitive function test items from NeuroCart: - Adaptive tracking (motor-coordination) - Body sway (postural stability) - Rapid visual information processing (RVIP) - Simple reaction time task - Symbol Digit Substitution Test (SDST, cognitive processing speed) - Pharmaco-EEG Pharmacokinetic endpoints: Tmax, Cmax, AUCinf, t1/2, Vd/f, CL/F Safety endpoints: Pulse, diastolic blood pressure, systolic blood pressure. | — |
Countries
The Netherlands
Outcome results
None listed