AMANTADINE AND TRANSCRANIAL MAGNETIC STIMULATION FOR TREATING FATIGUE IN MULTIPLE SCLEROSIS

Phase 1

• Conditions: Fatigue in multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-004868-95-ES
• Lead Sponsor: Fundación para la Inv. Biomédica Hospital Clínico San Carlos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-22
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Expanded Disability Status Scale mark 1.5 - 4.5
2. Fatigue Severity Scale > 4
3. Beck Depression Inventory < 19
4. Drug washout period = 4 weeks for any fatigue aimed drug
5. No relapse for, at least, a month prior to screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 144

Exclusion Criteria

1. Fatigue causing disease other than multiple sclerosis
2. Sleep apnea treated with CPAP devices
3. Other autoimmune disease which might cause fatigue
4. Cronic Fatigue Syndrome
5. Secondary Epilepsy or neuropathic cronic pain which requires continuous treatment.
6. High blood pressure out of control or cardiac condition.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the fatigue severity in patients with multiple sclerosis treated with amantadine, TMS or their combination in combination with placebo.;Secondary Objective: To assess the congnitive, depresion conditions and quality of live, a validated scale will be used for each aims. Thefore, it will be carried out a cost-effectivity and safety assement.;Primary end point(s): Compare clinical response to amantadine, TMS or the combination;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Cognitive recovery measured by SDMT test<br>2. Depression measured with Beck's scale<br>3. Life quality measured with SF-12 scale.<br>4. Safety<br>5. Cost-effectiviness;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment