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Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)

A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)

NCT04776213•Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT)
•Received at least a single dose of cladribine tablets in the CLARIFY MS study
•Completed the Final Study Visit (M24) of the CLARIFY MS study
•Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol

Exclusion Criteria

•Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
•Participation in other studies.

Locations (60)

Eva Maida

Vienna, Austria

FN u sv. Anny Brno

Brno, Czechia

FN Hradec Králové

Hradec Králové, Czechia

Nemocnice Jihlava, p.o.

Jihlava, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Faculty Hospital Kralovske Vinohrady

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Nemocnice Teplice

Teplice, Czechia

Glostrup Sygehus

Glostrup Municipality, Denmark

Key Dates

Start Date

February 23, 2021

Primary Completion Date

June 20, 2023

Completion Date

June 20, 2023

Last Updated

May 28, 2024

Enrollment

280

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

Mavenclad®

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis