Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis: Phase III Study, Controlled, Randomized, Crossed Over and Double Blind.
Overview
- Phase
- Phase 3
- Intervention
- Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule
- Conditions
- Multiple Sclerosis
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 144
- Locations
- 4
- Primary Endpoint
- To assess the fatigue severity
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Jorge Matías-Guiu
Principal Investigator
Hospital San Carlos, Madrid
Eligibility Criteria
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 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 6 month.
- •patient with diagnosis of chronic fatigue
- •Patient with high blood pressure out of range or decompensated heart failure or New York Heart Association (NYHA) 3-
- •Secondary Epilepsy or neuropathic chronic pain which requires continuous treatment.
- •Contraindication for trial treatment:
- •Some kind of magnetic metal.
- •Epilepsy antecedents.
Arms & Interventions
Amantadine
Intervention: Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule
Placebo
Intervention: Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule
TMS
Intervention: Transcranial Magnetic Stimulation
TMS sham
Intervention: Transcranial Magnetic Stimulation
Outcomes
Primary Outcomes
To assess the fatigue severity
Time Frame: 6 weeks after starting treatment
To compare the effect of TMS and amantadine alone or in combination therapy compared with placebo on fatigue determined using the Modified Fatigue Impact Scale (Total MFIS score: Range from 0 to 84, from minimal to severe fatigue).
Secondary Outcomes
- To assess the depression condition(6 weeks after starting treatment)
- Cost-effectivity assessment(6 weeks after starting treatment)
- To assess the cognitive condition(6 weeks after starting treatment)
- Safety assessment(6 months after randomization)
- To assess the quality of life(6 weeks after starting treatment)