Multiple sclerosis (MS)
Conditions
Interventions
The intervention group will receive 4 mg of clemastine fumarate twice daily (8
mg/day) for 6 months, the control group will receive an equivalent amount of
placebo. At baseline all participants will
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. A clinically definite diagnosis of multiple sclerosis. 2. Diagnosis of internuclear ophthalmoplegia determined by the first infrared oculography at screening with either cut-off of 1.174 of the versional dysconjugacy index area under the curve (VDI-AUC) of 15° saccades or 1.180 of the versional dysconjugacy index peak velocity/saccadic amplitude (VDI-PV/Am) of 15° saccades. 3. Age 18-70 (inclusive) 4. Use of disease modifying therapies is not a contraindication. 5. Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
Exclusion criteria
Exclusion criteria: MS-related exclusion criteria: 1. Changes in immunomodulatory therapy for multiple sclerosis in the 6 months before inclusion into the study. 2. Clinical relapse of MS or high dosage corticosteroid use within 30 days before inclusion into the study. IMP and medication related exclusion criteria: 3. Contraindications to clemastine use, such as known porphyria or hypersensitivity to clemastine, other antihistamines with a similar chemical structure or any of the excipients. 4. Contraindications to fampridine use, such as hypersensitivity to fampridine or any of the excipients, history of epilepsy, kidney disease (GFR 3 times the upper limit of normal. 11. Any ophthalmological disease which may prevent accurate infrared oculography assessment. 12. Suicidal ideation or behaviour in 6 months prior to baseline. 13. History of drug or alcohol abuse within the past year. 14. Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal or other major diseases that in the PI*s judgement may affect interpretation of study results or patient safety. 15. History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study. General exclusion criteria: 16. Pregnancy at the time of inclusion into the study or planning on breastfeeding within the first 7 months after inclusion in the study. 17. Involvement in other study protocol simultaneously without prior approval. 18. Insufficient proficiency in reading Dutch or English. 19. Unable or unwilling to suspend driving for a duration of 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the change in versional dysconjugacy index (VDI) of area under the curve (AUC) measured by infrared oculography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include changes in other VDI measures (peak velocity per amplitude (PV/Am) and peak velocity (PV)), changes in VDI after single fampridine dose, other oculography parameters (e.g. saccadic latency, anti-saccades), (peripheral) retinal nerve fibre layer (pRNFL) and (macular) ganglion cell inner plexiform layer (mGCIPL) thickness measured by Optical Coherence Tomography (OCT), Symbol Digit Modalities Test (SDMT), Expanded Disability Status Scale (EDSS), high and low contrast visual acuity, subjective visual functioning (NEI-VFQ-25 and NOV-AU questionnaire), quality of life (EQ5D-5L) and fatigue (CIS20R and NFI-MS questionnaire). | — |
Countries
Netherlands
Outcome results
None listed