AMANTADINE AND TRANSCRANIAL MAGNETIC STIMULATION FOR TREATING FATIGUE IN MULTIPLE SCLEROSIS

AMANTADINE AND TRANSCRANIAL MAGNETIC STIMULATION FOR TREATING FATIGUE IN MULTIPLE SCLEROSIS: PHASE III STUDY, CONTROLLED, RANDOMIZED, CROSSED OVER AND DOUBLE BLIND - FETEM

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004868-95-ES

Enrollment

144

Registered

2021-12-22

Start date

2022-05-26

Completion date

Unknown

Last updated

2022-05-30

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

Conditions

Fatigue in multiple sclerosis

Interventions

Trade Name: Amantadine Level Product Name: Amantadine Pharmaceutical Form: Capsule, hard INN or Proposed INN: INN CAS Number: 768-94-5 Current Sponsor code: test1 Other descriptive name: AMANTADINE HY

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Expanded Disability Status Scale mark 1.5 - 4.5 2. Fatigue Severity Scale > 4 3. Beck Depression Inventory =65 years) yes F.1.3.1 Number of subjects for this age range 144

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Spain

Contacts

Public ContactUICEC IdICSC

Fundación para la Investigación Biomédica del Hospital Clínico San Carlos

fibucicec.hcsc@salud.madrid.org+349133030007360

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026