Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis
NCT ID: NCT05809414
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
144 participants
INTERVENTIONAL
2022-11-28
2025-02-28
Brief Summary
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Detailed Description
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The main objective of the study is to evaluate the change in the severity of fatigue in MS patients undergoing treatment with amantadine, TMS and both in combination, compared to placebo. A randomized, placebo-controlled, crossover, double-blind clinical trial will be conducted. As secondary objectives, changes in cognition, depression and quality of life will be evaluated. For all this, the reference scales adequately validated for each of the objectives will be used.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Amantadine
Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule
It will be used at a dose of 100 mg, 1 capsule a day for 1 week, followed by 2 daily doses of 100 mg until completing 6 weeks in total. After completing the treatment phase, the dose will be de-escalated (1 capsule a day for 5 days and discontinued).
In the case of placebo amantadine capsules, they will have the same organoleptic characteristics as amantadine. The start, maintenance and de-escalation pattern will be identical.
Placebo
Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule
It will be used at a dose of 100 mg, 1 capsule a day for 1 week, followed by 2 daily doses of 100 mg until completing 6 weeks in total. After completing the treatment phase, the dose will be de-escalated (1 capsule a day for 5 days and discontinued).
In the case of placebo amantadine capsules, they will have the same organoleptic characteristics as amantadine. The start, maintenance and de-escalation pattern will be identical.
TMS
Transcranial Magnetic Stimulation
TMS is a technique for electrical stimulation of brain tissue by generating a magnetic field, which modulates neural activity at the stimulation site and in interconnected neural networks.
The treatment will be applied to the left dorsolateral prefrontal region. Each patient will receive 3 sessions per week of approximately 10 minutes for 6 weeks.
In the case of TMS sham, a placebo coil will be used, which is indistinguishable from the therapeutic one. In addition, the sessions will be carried out with the same frequency, so the patient will be unaware of the treatment they are receiving.
TMS sham
Transcranial Magnetic Stimulation
TMS is a technique for electrical stimulation of brain tissue by generating a magnetic field, which modulates neural activity at the stimulation site and in interconnected neural networks.
The treatment will be applied to the left dorsolateral prefrontal region. Each patient will receive 3 sessions per week of approximately 10 minutes for 6 weeks.
In the case of TMS sham, a placebo coil will be used, which is indistinguishable from the therapeutic one. In addition, the sessions will be carried out with the same frequency, so the patient will be unaware of the treatment they are receiving.
Interventions
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Transcranial Magnetic Stimulation
TMS is a technique for electrical stimulation of brain tissue by generating a magnetic field, which modulates neural activity at the stimulation site and in interconnected neural networks.
The treatment will be applied to the left dorsolateral prefrontal region. Each patient will receive 3 sessions per week of approximately 10 minutes for 6 weeks.
In the case of TMS sham, a placebo coil will be used, which is indistinguishable from the therapeutic one. In addition, the sessions will be carried out with the same frequency, so the patient will be unaware of the treatment they are receiving.
Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule
It will be used at a dose of 100 mg, 1 capsule a day for 1 week, followed by 2 daily doses of 100 mg until completing 6 weeks in total. After completing the treatment phase, the dose will be de-escalated (1 capsule a day for 5 days and discontinued).
In the case of placebo amantadine capsules, they will have the same organoleptic characteristics as amantadine. The start, maintenance and de-escalation pattern will be identical.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Fatigue Severity Scale \> 4
3. Beck Depression Inventory \< 30
4. No relapse for, at least, three month prior to screening
5. Drug washout period = 4 weeks for any fatigue aimed drug
6. Patient capable to sign the informed consent
Exclusion Criteria
1. sleep apnea
2. other autoimmune disease that could be explain the fatigue.
3. endocrine autoimmune disease if the blood test is not in range in the last 6 month.
4. patient with diagnosis of chronic fatigue
5. Patient with high blood pressure out of range or decompensated heart failure or New York Heart Association (NYHA) 3-4.
2. Secondary Epilepsy or neuropathic chronic pain which requires continuous treatment.
3. Contraindication for trial treatment:
1. Some kind of magnetic metal.
2. Epilepsy antecedents.
3. Any drugs that could decrease the seizure threshold
4. Amantadine sensitivity
5. Cardiopathy disease, severe kidney failure, Angle-closure glaucoma
4. Breastfeeding, pregnancy, or pregnancy planning phase in the next year. Of childbearing potential and willing to use an acceptable method of contraception during the study period.
5. Patient with a terminal disease with no more than one year life expectancy.
6. Patient has been treated for a maligned disease in the past three years.
7. A scheduled surgery in the course of the trials.
8. Any condition that a member of research team consider could affect to participation/follow up patient.
9. Alcoholic o toxics condition in the last year.
10. Major mental disorders
11. Poor communication skills or poor cognitive condition.
12. Other trial participation in the previous 4 month.
13. Use a chronic drug that could interfere in the clinical outcome.
18 Years
ALL
No
Sponsors
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Hospital San Carlos, Madrid
OTHER
Responsible Party
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Jorge Matías-Guiu
Principal Investigator
Principal Investigators
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Jorge Matias-Guiu Guia, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital San Carlos, Madrid
Locations
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Hospital Puerta del Mar
Cadiz, , Spain
Hospital General Gregorio Marañon
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospitalario Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, , Spain
Countries
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Central Contacts
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Facility Contacts
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Lucía Forero Díaz, MD PhD
Role: primary
María Luisa Martínez Ginés, MD PhD
Role: primary
Jorge Matias-Guiu Guia, MD PhD
Role: primary
Miguel Ángel Hernández Pérez, MD PhD
Role: primary
References
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Matias-Guiu JA, Gonzalez-Rosa J, Hernandez MA, Martinez-Gines ML, Portoles A, Perez-Macias N, Benito-Leon J, Padron I, Prieto J, Matias-Guiu J. Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial. BMJ Open. 2024 Jan 4;14(1):e078661. doi: 10.1136/bmjopen-2023-078661.
Other Identifiers
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FETEM
Identifier Type: -
Identifier Source: org_study_id