Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis

Last updated: December 4, 2023
Sponsor: Hospital San Carlos, Madrid
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Pain (Pediatric)

Memory Loss

Treatment

Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule

Transcranial Magnetic Stimulation

Clinical Study ID

NCT05809414
FETEM
  • Ages > 18
  • All Genders

Study Summary

Multiple Sclerosis (MS) is the most frequent cause of non-traumatic disability in people under 55 years of age. Fatigue is the most frequent and disabling symptom in the disease, and for which there is no effective treatment. Among the proposed drugs, amantadine is the one that could be most useful, although up to now it has not been adequately demonstrated due to a lack of sufficiently powerful and methodologically appropriate clinical trials. Transcranial magnetic stimulation (TMS) has recently been proposed as a useful treatment for fatigue in MS in preliminary studies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Expanded Disability Status Scale mark 1.5 - 4.5
  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

Exclusion Criteria:

  1. Fatigue causing disease other than multiple sclerosis:
  2. sleep apnea
  3. other autoimmune disease that could be explain the fatigue.
  4. endocrine autoimmune disease if the blood test is not in range in the last 6month.
  5. patient with diagnosis of chronic fatigue
  6. Patient with high blood pressure out of range or decompensated heart failure orNew York Heart Association (NYHA) 3-4.
  7. Secondary Epilepsy or neuropathic chronic pain which requires continuous treatment.
  8. Contraindication for trial treatment:
  9. Some kind of magnetic metal.
  10. Epilepsy antecedents.
  11. Any drugs that could decrease the seizure threshold
  12. Amantadine sensitivity
  13. Cardiopathy disease, severe kidney failure, Angle-closure glaucoma
  14. Breastfeeding, pregnancy, or pregnancy planning phase in the next year. Ofchildbearing potential and willing to use an acceptable method of contraception duringthe study period.
  15. Patient with a terminal disease with no more than one year life expectancy.
  16. Patient has been treated for a maligned disease in the past three years.
  17. A scheduled surgery in the course of the trials.
  18. Any condition that a member of research team consider could affect toparticipation/follow up patient.
  19. Alcoholic o toxics condition in the last year.
  20. Major mental disorders
  21. Poor communication skills or poor cognitive condition.
  22. Other trial participation in the previous 4 month.
  23. Use a chronic drug that could interfere in the clinical outcome.

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule
Phase: 3
Study Start date:
November 28, 2022
Estimated Completion Date:
February 28, 2025

Study Description

Multiple Sclerosis (MS) is the most frequent cause of non-traumatic disability in people under 55 years of age. Fatigue is the most frequent and disabling symptom in the disease, and for which there is no effective treatment. Among the proposed drugs, amantadine is the one that could be most useful, although up to now it has not been adequately demonstrated due to a lack of sufficiently powerful and methodologically appropriate clinical trials. Transcranial magnetic stimulation (TMS) has recently been proposed as a useful treatment for fatigue in MS in preliminary studies.

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.

Connect with a study center

  • Hospital Puerta del Mar

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital General Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospitalario Universitario Nuestra Señora de la Candelaria

    Santa Cruz De Tenerife, 38010
    Spain

    Active - Recruiting

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