E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
autism spectrum disorders Trastornos del Espectro Autista |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063844 |
E.1.2 | Term | Autism spectrum disorder |
|
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 |
To assess oxidative metabolism status and levels of Poli-Unsaturated Fatty Acids (PUFAS) in Autism Spectrum Disorder (ASD) patients before and after an 8 week treatment with essential fatty acids omega-3 (EFA-3) or placebo (PLO). |
|
E.2.2 | Secondary objectives of the trial |
-To assess Global Cinical Impression before and after treatment with EFA-3 or PLO -To assess disruptive behaviours and other related symptoms, measured by ABC, CBCL and SRS before and after treatment with EFA-3 or PLO -To assess the presence of symtoms or signs of fatty acids deficiency before and after a treatment with EFA-3 or PLO. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Diagnosis of an Autism Spectrum Disorder. Diagnosed made by fulfilling 2 of the following 3: DSM-IV criteria for any of the Pervasive Developmental Disorders (except for Asperger Syndrome in which case Gillberg criteria substitute DSM-IV criteria), ADOS interview and clinical judgement. -Age at recruitment between 5 and 17 -Written consent form signed by a parent or legal representative and minor (if over 12 and capable to give consent) |
|
E.4 | Principal exclusion criteria |
-Other pscyhiatric diagnosis of Axis I -Drug abuse/dependence -Medical contraindication for the ingestion of fatty acids or vitamin E -Treatment with anticoagulants -Treatment with nutritional supplements -Treatment with antipsychotics -Concomitant structured psychotherapeutic treatment -Medical conditions that affect oxidative metabolism or for which the patients are taking drugs that affect oxidative metabolism |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Niveles de estrés oxidativo tras el tratamiento, medido como niveles de PUFAS en membrana de eritrocitos, TAOS y niveles de glutatión en plasma. |
|
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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |