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AMANTADINE AND TRANSCRANIAL MAGNETIC TRANSCRANIAL MAGNETIC STIMULATION FOR FATIGUE IN MULTIPLE SCLEROSIS: A PHASE III, CONTROLLED, RANDOMISED, DOUBLE-BLIND, CROSSOVER TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516732-97-00
Acronym
FETEM
Enrollment
144
Registered
2024-09-11
Start date
2022-11-28
Completion date
Unknown
Last updated
2024-09-11

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

Conditions

multiple sclerosis (MS)

Brief summary

The change in the values of the MFIS questionnaire is considered as the main study variable for the evaluation of effectiveness.

Detailed description

- Patient-perceived quality of life. The change in the mean score of the patient-perceived quality of life scale (SF-12) between the time of inclusion in the study and at the beginning and end of each phase will be assessed. - Beck Depression Inventory-II to assess depressive symptomatology. The assessment will be made at inclusion, and at the beginning and end of each phase. - Total costs per patient. Total costs of hospitalisation and treatment as well as other health care will be measured. -

Interventions

DRUGAmantadine Level 100 mg cápsulas duras

Sponsors

Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The change in the values of the MFIS questionnaire is considered as the main study variable for the evaluation of effectiveness.

Secondary

MeasureTime frame
- Patient-perceived quality of life. The change in the mean score of the patient-perceived quality of life scale (SF-12) between the time of inclusion in the study and at the beginning and end of each phase will be assessed. - Beck Depression Inventory-II to assess depressive symptomatology. The assessment will be made at inclusion, and at the beginning and end of each phase. - Total costs per patient. Total costs of hospitalisation and treatment as well as other health care will be measured. -

Countries

Spain

Outcome results

None listed

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