Clemastine fumarate as remyelinating treatment in internuclear ophthalmoparesis and multiple sclerosis (RESTORE)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513099-17-00

Enrollment

Registered

2024-08-14

Start date

2022-08-30

Completion date

2025-08-15

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internuclear ophthalmoparesis, Multiple sclerosis

Brief summary

The relative change in Versional Dysconjugacy Index (VDI) of Area under the Curve (AUC) from baseline will be compared between the treatment and control group at the end of treatment (6 months) and multiple follow-up periods (12, 24 and 36 months)

Interventions

DRUGCapsules for oral use otherwise identical to IMP clemastine

DRUGClemastine Milstein 1 mg

DRUGtabletten

DRUGFampyra 10 mg prolonged-release tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The relative change in Versional Dysconjugacy Index (VDI) of Area under the Curve (AUC) from baseline will be compared between the treatment and control group at the end of treatment (6 months) and multiple follow-up periods (12, 24 and 36 months)	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026