Multiple SclerosisPhase 3RESTORENCT05338450
Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis
A Phase 3 study testing Clemastine Fumarate in people with Multiple Sclerosis and Internuclear Ophthalmoplegia, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Rationale: Clemastine fumarate has been identified as potential remyelinating therapy for multiple sclerosis (MS). The (long-term) effects of clemastine need to be confirmed in clinical models for MS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Internuclear Ophthalmoplegia
- What is being tested?
- Clemastine Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Aug 2022to 15 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Clemastine fumarate has been identified as potential remyelinating therapy for multiple sclerosis (MS). The (long-term) effects of clemastine need to be confirmed in clinical models for MS. Internuclear ophthalmoparesis (INO) may be used as a clinical model for investigating remyelinating therapies by measuring horizontal eye movements with infrared oculography. Furthermore, infrared oculography combined with a single dose of fampridine may be used to identify individuals with MS that are most likely to benefit from remyelinating therapy.
Objective: To assess the (long-term) efficacy of clemastine fumarate in improving dysconjugacy of eye movements in patients with internuclear ophthalmoparesis and multiple sclerosis. Secondly, to assess whether a response to a single dose of fampridine can predict the effects of clemastine treatment.
Read more
Study design: A single-centre double-blind randomized placebo-controlled trial consisting of a 6 months (180 days) treatment period followed by a 30 months follow-up period.
Study population: 80 MS patients, age 18-70 years, with INO.
Intervention: The intervention group will receive 4 mg of clemastine fumarate twice daily (8 mg/day) for 6 months (180 days), the control group will receive an equivalent amount of placebo. At baseline all participants will receive a single 10 mg dose of fampridine.
Main study parameters/endpoints: The primary outcome measure is the change in versional dysconjugacy index (VDI) of area under the curve (AUC) measured by infrared oculography. 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 OCT, SDMT, 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).
Nature and extent of the burden and risks: Participation in the study will consist of a total of 7 study visits. Study visits will include physical/neurological examination, infrared oculography, OCT, visual acuity tests, a cognition test (SDMT), 5 questionnaires and blood samples for safety laboratory tests. Considering both clemastine and fampridine are registered and well-established drugs and have been used in clinical practice, the estimated risk of unexpected adverse reactions is low.
- Conditions
- Multiple Sclerosis, Internuclear Ophthalmoplegia
- Being tested
- Clemastine Fumarate, Placebo
- Keywords
- clemastine, fampridine, remyelination, eye-tracking, infrared oculography
- Medical subject headings
- Multiple Sclerosis, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clemastine FumarateDrug
Also called clemastine, Tavegyl
4 mg of Clemastine Fumarate twice daily (8mg/day) orally for 6 months (180 days)
PlaceboDrug
Placebo equivalent to experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Clemastine Fumarate | Experimental | Not described Receives: Drug: Clemastine Fumarate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Versional Dysconjugacy Index (VDI) - Area Under the Curve (VDI-AUC) (6 months)
Our main study parameter is the versional dysconjugacy index (VDI) measured by infrared oculography. The relative change in VDI from baseline will be compared between the treatment and control group at the end of treatment (6 months). The VDI of Area Under the Curve (AUC) will be our primary study parameter. This describes the area under the saccadic trajectory of the horizontal eye position.
Measured: 6 months
Versional Dysconjugacy Index (VDI) - Area Under the Curve (VDI-AUC) (36 months)
The relative change in VDI from baseline will be compared between the treatment and control group at the end of follow-up (36 months).
Measured: 36 months
Secondary outcomes (14)
Other Versional Dysconjugacy Index (VDI) measures - Peak Velocity (VDI-pV + VDI-pV/Am)
Changes in other VDI measures (peak velocity (PV) and peak velocity divided by amplitude (PV/Am)).
Measured: 6 and 36 months
Versional Dysconjugacy Index (VDI) - Response to Fampridine
Changes in VDI in response to single dose of Fampridine.
Measured: Baseline
Other infrared oculography parameters - Saccadic Latency
Changes in saccadic latency measured by infrared oculography.
Measured: 6 months and 36 months
Other infrared oculography parameters - Proportion of errors in an anti-saccadic task
Changes in proportion of errors in an anti-saccadic task measured by infrared oculography.
Measured: 6 months and 36 months
Other infrared oculography parameters - Proportion of correct double-step saccades
Changes in the proportion of correct double-step saccades measured by infrared oculography.
Measured: 6 months and 36 months
Other infrared oculography parameters - Error of the final eye position in double-step saccades
Changes in the error of the final eye position in double-step saccades measured by infrared oculography.
Measured: 6 months and 36 months
Symbol Digit Modalities Test (SDMT)
Measured: 6 months and 36 months
Expanded Disability Status Scale (EDSS)
Changes in the Expanded Disability Status Scale (EDSS), which ranges from 0 (normal neurological exam, no disability) to 10.0 (death due to MS).
Measured: 6 months and 36 months
High and Low Contrast Visual Acuity (HCVA and LCVA)
Measured: 6 months and 36 months
Subjective visual functioning (NEI-VFQ-25)
Changes in subjective visual functioning measured by the National Eye Institute Visual Functioning Questionnaire - 25 (NEI-VFQ-25) questionnaire.
Measured: 6 months and 36 months
Visual complaints (NOV-AU)
Changes in visual complaints measured by the Neuro-Ophthalmology Questionnaire Amsterdam UMC (NOV-AU) questionnaire.
Measured: 6 months and 36 months
Quality of life (EQ5D-5L)
Changes in quality of life measured by EuroQol 5-Dimension 5-Level (EQ5D-5L) questionnaire.
Measured: 6 months and 36 months
Fatigue - CIS20R
Prevalence and changes in fatigue measured by the Checklist Individual Strength (CIS20R) questionnaire.
Measured: 6 months and 36 months
Fatigue - NFI-MS
Prevalence and changes in fatigue measured by the Neurological Fatigue Index MS (NFI-MS) questionnaire.
Measured: 6 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start30 Aug 2022
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Why it stopped: In line with the study protocol, due to slow recruitment, a futility analysis has been performed in the first quarter of 2025 by an independent statistician. The result of the analysis was restricted to a "no-go".
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Hof, Amsterdam UMC, location VUmc
- Investigators
- Axel Petzold, Dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338450
- Sponsor's protocol ID
- NL78363.029.21
- Other IDs
- 2024-513099-17-00, 2021-003677-66
- Acronym
- RESTORE
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hof S, van Rijn LJ, Uitdehaag BMJ, Nij Bijvank JA, Petzold A. Measuring and predicting the effect of remyelinating therapy in multiple sclerosis: a randomised controlled trial protocol (RESTORE). BMJ Open. 2024 Jan 30;14(1):e076651. doi: 10.1136/bmjopen-2023-076651.
PubMed 38296293
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05338450
- Acronym / sponsor ID
- RESTORE / NL78363.029.21
- Conditions
- Multiple Sclerosis, Internuclear Ophthalmoplegia
- Keywords
- clemastine, fampridine, remyelination, eye-tracking, infrared oculography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In line with the study protocol, due to slow recruitment, a futility analysis has been performed in the first quarter of 2025 by an independent statistician. The result of the analysis was restricted to a "no-go".
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Clemastine fumarate has been identified as potential remyelinating therapy for multiple sclerosis (MS). The (long-term) effects of clemastine need to be confirmed in clinical models for MS. Internuclear ophthalmoparesis (INO) may be used as a clinical model for investigating remyelinating therapies by measuring horizontal eye movements with infrared oculography. Furthermore, infrared oculography combined with a single dose of fampridine may be used to identify individuals with MS that are most likely to benefit from remyelinating therapy.
Objective: To assess the (long-term) efficacy of clemastine fumarate in improving dysconjugacy of eye movements in patients with internuclear ophthalmoparesis and multiple sclerosis. Secondly, to assess whether a response to a single dose of fampridine can predict the effects of clemastine treatment.
Study design: A single-centre double-blind randomized placebo-controlled trial consisting of a 6 months (180 days) treatment period followed by a 30 months follow-up period.
Study population: 80 MS patients, age 18-70 years, with INO.
Intervention: The intervention group will receive 4 mg of clemastine fumarate twice daily (8 mg/day) for 6 months (180 days), the control group will receive an equivalent amount of placebo. At baseline all participants will receive a single 10 mg dose of fampridine.
Main study parameters/endpoints: The primary outcome measure is the change in versional dysconjugacy index (VDI) of area under the curve (AUC) measured by infrared oculography. 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 OCT, SDMT, 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).
Nature and extent of the burden and risks: Participation in the study will consist of a total of 7 study visits. Study visits will include physical/neurological examination, infrared oculography, OCT, visual acuity tests, a cognition test (SDMT), 5 questionnaires and blood samples for safety laboratory tests. Considering both clemastine and fampridine are registered and well-established drugs and have been used in clinical practice, the estimated risk of unexpected adverse reactions is low.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clemastine Fumarate | Experimental | Drug: Clemastine Fumarate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clemastine FumarateAlso: clemastine, Tavegyl4 mg of Clemastine Fumarate twice daily (8mg/day) orally for 6 months (180 days) | Drug | Clemastine Fumarate |
| PlaceboPlacebo equivalent to experimental arm | Drug | Placebo |
Primary outcome
Versional Dysconjugacy Index (VDI) - Area Under the Curve (VDI-AUC) (6 months)
Time frame: 6 months
Our main study parameter is the versional dysconjugacy index (VDI) measured by infrared oculography. The relative change in VDI from baseline will be compared between the treatment and control group at the end of treatment (6 months). The VDI of Area Under the Curve (AUC) will be our primary study parameter. This describes the area under the saccadic trajectory of the horizontal eye position.
Versional Dysconjugacy Index (VDI) - Area Under the Curve (VDI-AUC) (36 months)
Time frame: 36 months
The relative change in VDI from baseline will be compared between the treatment and control group at the end of follow-up (36 months).
14 secondary outcomes
Other Versional Dysconjugacy Index (VDI) measures - Peak Velocity (VDI-pV + VDI-pV/Am)
Time frame: 6 and 36 months
Versional Dysconjugacy Index (VDI) - Response to Fampridine
Time frame: Baseline
Other infrared oculography parameters - Saccadic Latency
Time frame: 6 months and 36 months
Other infrared oculography parameters - Proportion of errors in an anti-saccadic task
Time frame: 6 months and 36 months
Other infrared oculography parameters - Proportion of correct double-step saccades
Time frame: 6 months and 36 months
Other infrared oculography parameters - Error of the final eye position in double-step saccades
Time frame: 6 months and 36 months
Symbol Digit Modalities Test (SDMT)
Time frame: 6 months and 36 months
Expanded Disability Status Scale (EDSS)
Time frame: 6 months and 36 months
High and Low Contrast Visual Acuity (HCVA and LCVA)
Time frame: 6 months and 36 months
Subjective visual functioning (NEI-VFQ-25)
Time frame: 6 months and 36 months
Visual complaints (NOV-AU)
Time frame: 6 months and 36 months
Quality of life (EQ5D-5L)
Time frame: 6 months and 36 months
Fatigue - CIS20R
Time frame: 6 months and 36 months
Fatigue - NFI-MS
Time frame: 6 months and 36 months
Results and safety
The study was stopped early (reason given: In line with the study protocol, due to slow recruitment, a futility analysis has been performed in the first quarter of 2025 by an independent statistician. The result of the analysis was restricted to a "no-go".). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 38296293Hof S, van Rijn LJ, Uitdehaag BMJ, Nij Bijvank JA, Petzold A. Measuring and predicting the effect of remyelinating therapy in multiple sclerosis: a randomised controlled trial protocol (RESTORE). BMJ Open. 2024 Jan 30;14(1):e076651. doi: 10.1136/bmjopen-2023-076651.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Petzold, Dr. principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clemastine Fumarate in people with Multiple Sclerosis and Internuclear Ophthalmoplegia, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: In line with the study protocol, due to slow recruitment, a futility analysis has been performed in the first quarter of 2025 by an independent statistician. The result of the analysis was restricted to a "no-go".). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Versional Dysconjugacy Index (VDI) - Area Under the Curve (VDI-AUC) (6 months) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05338450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.