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Old allergy drug may help repair nerves in MS patients

NCT ID NCT05338450

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether clemastine fumarate, an allergy medication, could improve eye movement problems in people with multiple sclerosis (MS). The trial planned to enroll 80 MS patients with a specific eye condition called internuclear ophthalmoparesis, but was terminated early with 47 participants. Participants took either clemastine or a placebo for 6 months, and researchers measured eye movements using infrared technology.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
clemastine fumarate (antihistamine)
What this could lead to
If it works, this could point toward a treatment that repairs nerve insulation in multiple sclerosis, potentially improving eye coordination and other symptoms.
What could go wrong
The trial was terminated early with only 47 of 80 planned participants, so results may be inconclusive. Clemastine is an older antihistamine, and its effect on nerve repair is still unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

47 people

The number who actually took part.

Started

Aug 2022

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * A clinically definite diagnosis of multiple sclerosis. * Diagnosis of internuclear ophthalmoparesis 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. * Age 18-70 (inclusive) * Use of disease modifying therapies is not a contraindication. * Ability to understand the purpose and risks of the study and provide signed and dated informed consent. Exclusion criteria: MS-related exclusion criteria: * Changes in immunomodulatory therapy for multiple sclerosis in the 6 months before inclusion into the study. * Clinical relapse of MS or high dosage corticosteroid use within 30 days before inclusion into the study. IMP and medication related exclusion criteria: * Contraindications to clemastine use, such as known porphyria or hypersensitivity to clemastine, other antihistamines with a similar chemical structure or any of the excipients. * Contraindications to fampridine use, such as hypersensitivity to fampridine or any of the excipients, history of epilepsy, kidney disease (GFR \<50 ml/min absolute contraindication; GFR = 50-80 ml/min relative contraindication), use of Organic Cation Transporter 2 (OCT2) inhibitors or history of significant cardiac arrhythmias or conduction block. * Concomitant use of Fampridine or any other formulation of 4-aminopyridine (4AP) or diamino4ap that cannot be temporarily suspended prior to each study visit. * Changes in the use of medication currently being investigated in remyelination trials within 6 months before screening, including but not limited to domperidone, liothyronine, quetiapine, testosterone and bazedoxifene. * Non-incidental use of central nervous system depressants including but not limited to hypnotics, anxiolytics, monoamine-oxidase inhibitors (MAOI'S), tricyclic antidepressants, opioid analgesics and other antihistamines with sedating properties (e.g. promethazine). Other medical history and concomitant disease exclusion criteria: * History of significant cardiac conduction block. * History of malignancy of any organ system (other than localized squamous or basal cell carcinoma of the skin or adequately treated cervical cancer), treated or untreated, within the past 3 years, regardless of whether there is evidence of local recurrence or metastases. * Estimated glomerular filtration rate (eGFR) \< 50 ml/min/1.73 m2; AST, ALT, or alkaline phosphatase \> 2 times the upper limit of normal. * Any ophthalmological disease which may prevent accurate infrared oculography assessment. * Suicidal ideation or behaviour in 6 months prior to baseline. * History of drug or alcohol abuse within the past year. * 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. * 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: * Pregnancy at the time of inclusion into the study or planning on breastfeeding within the first 7 months after inclusion in the study. * Involvement in other study protocol simultaneously without prior approval. * Insufficient proficiency in reading Dutch. * Unable or unwilling to suspend driving for a duration of 6 months.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Amsterdam UMC, location VUmc

    Amsterdam, 1081 HV, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.