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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Expanded Disability Status Scale mark 1.5 - 4.5
- Fatigue Severity Scale > 4
- Beck Depression Inventory < 30
- No relapse for, at least, three month prior to screening
- Drug washout period = 4 weeks for any fatigue aimed drug
- Patient capable to sign the informed consent
Exclusion
Exclusion Criteria:
- Fatigue causing disease other than multiple sclerosis:
- sleep apnea
- other autoimmune disease that could be explain the fatigue.
- endocrine autoimmune disease if the blood test is not in range in the last 6month.
- patient with diagnosis of chronic fatigue
- Patient with high blood pressure out of range or decompensated heart failure orNew York Heart Association (NYHA) 3-4.
- Secondary Epilepsy or neuropathic chronic pain which requires continuous treatment.
- Contraindication for trial treatment:
- Some kind of magnetic metal.
- Epilepsy antecedents.
- Any drugs that could decrease the seizure threshold
- Amantadine sensitivity
- Cardiopathy disease, severe kidney failure, Angle-closure glaucoma
- Breastfeeding, pregnancy, or pregnancy planning phase in the next year. Ofchildbearing potential and willing to use an acceptable method of contraception duringthe study period.
- Patient with a terminal disease with no more than one year life expectancy.
- Patient has been treated for a maligned disease in the past three years.
- A scheduled surgery in the course of the trials.
- Any condition that a member of research team consider could affect toparticipation/follow up patient.
- Alcoholic o toxics condition in the last year.
- Major mental disorders
- Poor communication skills or poor cognitive condition.
- Other trial participation in the previous 4 month.
- 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
Connect with a study center
Hospital Puerta del Mar
Cadiz, 11009
SpainActive - Recruiting
Hospital Clínico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital General Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Hospitalario Universitario Nuestra Señora de la Candelaria
Santa Cruz De Tenerife, 38010
SpainActive - Recruiting
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