E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fibromialgia |
Fibromialgia |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic pain in bones and muscles |
Dolor crónico en huesos y músculos |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048439 |
E.1.2 | Term | Fibromyalgia |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the efficacy of memantine in the reduction of glutamate brain levels in patients with fibromialgia |
Evaluar la eficacia de memantina en la reducción de los niveles cerebrales de glutamato en pacientes con fibromialgia |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of memantine in the treatnebt of the pain and other symptoms in fibromialgia |
Evaluar la eficacia de la memantina en el tratamiento del dolor y de otros síntomas en la fibromialgia |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Edad entre 18 y 65 años. - Capacidad para comprender el español. - Diagnóstico de fibromialgia según American College of Rheumatology, realizado por reumatólogo. - Discontinuación del tratamiento farmacológico una semana antes de empezar el estudio. Se incluyen antidepresivos (duloxetina, venlafaxina, mirtazapina, bupropion, ISRS, tricíclicos, etc.), analgésicos (pregabalina, gabapentina, opiáceos, etc.) y otros fármacos utilizados en el tratamiento de la fibromialgia (hipnóticos, ansiolíticos, etc). Durante esa semana, los pacientes podrán tomar, en caso de que sea necesario y de forma puntual, analgésicos como tramadol o paracetamol, para minimizar la influencia de la medicación en imágenes cerebrales. Este período de lavado es el que habitualmente se emplea en estudios de neuroimagen similares |
|
E.4 | Principal exclusion criteria |
-Pacientes que tengan otra enfermedad psiquiátrica del eje I utilizando SCID-I que puedan dificultar el seguimiento del protocolo (ej: demencia, abuso/dependencia de alcohol y/o sustancias, trastorno esquizofrénico, trastorno delirante crónico). - Pacientes embarazadas o en el período de lactancia materna. - Hipersensibilidad al principio activo o a los excipientes. - Enfermedades que requieren precauciones especiales cuando se administra memantina según ficha técnica: 1.- Epilepsia. 2.- Circunstancias que puedan producir elevación del PH urinario (ej: infecciones urinarias por Proteus, acidosis tubular renal, dieta vegetariana), infarto de miocardio reciente, enfermedad cardiaca congestiva e hipertensión arterial no controlada. - Ingesta de fármacos que puedan producir interacciones relevantes con memantina según ficha técnica: agonistas del NMDA (amantadina, ketamina, dextrometorfano), L-Dopa, agonistas dopaminérgicos y agonistas colinérgicos. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reducción de los niveles cerebrales de glutamato |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Basal, 1 month, 3 months |
Basal, 1 mes, 3 meses |
|
E.5.2 | Secondary end point(s) |
Variables clínicas: -Datos sociodemográficos -Umbral del dolor, valorado mediante esfigmomanómetro -Dolor percibido, mediante una escala visual analógica (EVA) -Estado cognitivo, evaluado mediante el Mini-Examen Cognoscitivo (MEC) -Estado de salud en fibromialgia evaluado por el Fibromyalgia Impact Questionnaire (FIQ) -Estado de ansiedad y depresión, valorado mediante la Hospital Anxiety Depression Scale (HADS) -Calidad de vida, evaluada mediante el cuestionario EuroQol 5D (EQ5D |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Basal, 1 month, 3 months |
Basal, 1 mes, 3 meses |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last patient last visit |
Última visita del último paciente en marcha |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |