Q10 Ubiquinol in Autism Spectrum Disorder and in Phelan-McDermid Syndrome. (Q10ASD)
Autism Spectrum Disorder, Phelan-McDermid Syndrome
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Ubiquinol-10, Coenzyme Q10, Autism, Mitochondria, Oxidative stress, Cognitive symptoms, Chromosome 22q13 3 deletion syndrome
Eligibility Criteria
Inclusion Criteria:
- Both parents or a legally authorized patient representative (LAR) must provide written informed consent. The parents and guardian must be able to understand and comply with the experimental protocol;
- Subjects of both sexes, aged between 2 and 40 years old, may be included in the study;
- The subject must meet DSM-5 criteria for a primary diagnosis of Autism Spectrum Disorder (idiopathic autism) or carry a documented deletion of human chromosome 22q13.33 or mutation in the SHANK3 gene (Phelan-McDermid Syndrome);
- Subjects with idiopathic autism must pass the threshold score for Autism of the Autism Diagnostic Observation Schedule;
- Baseline Children's Global Assessment Scale score must be between 45 and 59;
- Patients treated with psychoactive drugs (neuroleptics, antiepileptics, etc.) are enrolled only if the treatment and dosage of these drugs has been constant for at least 3 months prior to enrollment in the trial and is kept constant throughout the 8-month duration of the trial;
- Patients undergoing any kind of behavioral intervention must have must have started the intervention at least 3 months prior to enrollment and the intervention must remain unchanged throughout the 8-month duration of the trial;
- The patient is able to swallow the capsule or his/her parents are available to open it and administer immediately its content in a small quantity of juice or soft-drink.
Exclusion Criteria:
Patients who meet any of the following criteria will not be recruited in the study:
- Patients with autism secondary to known genetic syndromes other than Phelan-McDermid syndrome (for example, Rett syndrome, fragile-X syndrome, etc.);
- Presence of brain malformations or major structural anomalies visible by magnetic resonance imaging;
- Patients with autism secondary to epileptic encephalopathy or with idiopathic autism comorbid with seizures more frequent than one episode every 6 months despite ongoing antiepileptic drug therapy;
- Patients with autism accompanied by marked facial dysmorphism and/or congenital malformations;
- Patients treated with anticoagulants;
- Patients with serious medical illnesses (chronic renal disease, severe liver disease, cardiovascular disorders, uncontrolled hypertension with systolic pressure values> 170 and diastolic pressure> 100 mm Hg, malignant tumors, HIV infection);
- Patients with a history of acute cerebrovascular episodes;
- Patients with a history of stomach bleeding or active peptic ulcer;
- Patients with documented allergy, hypersensitivity or intolerance to one of the excipients of the experimental or comparative product.
Trial interruption criteria:
- Patients whose medical conditions require starting treatment with anticoagulants.
- Patients with severe medical conditions starting during the 8-month duration of the trial.
- Patients who undergo a change in psychopharmacological or behavioral treatment during the 8-month duration of the trial.
Sites / Locations
- Interdipartimental Program "Autismo 0-90" at "G. Martino" Universitary Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Experimental
PMS Placebo
ASD Placebo
PMS Active compound
ASD Active compound
If body weight is up to 20 kg: Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (1.05 mg), Vit. B2 (1.2 mg), Niacin (9 mg), Pantothenic acid (4.5 mg), Vit. B6 (1.5 mg), Vit. B12 (4.5 mcg), Folic acid (0.1 mg), Biotin (0.1125 mg) If body weight is above 20 kg: Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (2.1 mg), Vit. B2 (2.4 mg), Niacin (18 mg), Pantothenic acid (9 mg), Vit. B6 (3 mg), Vit. B12 (9 mcg), Folic acid (0.2 mg), Biotin (0.225 mg)
If body weight is up to 20 kg: Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (1.05 mg), Vit. B2 (1.2 mg), Niacin (9 mg), Pantothenic acid (4.5 mg), Vit. B6 (1.5 mg), Vit. B12 (4.5 mcg), Folic acid (0.1 mg), Biotin (0.1125 mg) If body weight is above 20 kg: Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (2.1 mg), Vit. B2 (2.4 mg), Niacin (18 mg), Pantothenic acid (9 mg), Vit. B6 (3 mg), Vit. B12 (9 mcg), Folic acid (0.2 mg), Biotin (0.225 mg)
If body weight is up to 20 kg: Q10 ubiquinol, 50 mg b.i.d. Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (1.05 mg), Vit. B2 (1.2 mg), Niacin (9 mg), Pantothenic acid (4.5 mg), Vit. B6 (1.5 mg), Vit. B12 (4.5 mcg), Folic acid (0.1 mg), Biotin (0.1125 mg) If body weight is above 20 kg: Q10 ubiquinol, 100 mg b.i.d. Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (2.1 mg), Vit. B2 (2.4 mg), Niacin (18 mg), Pantothenic acid (9 mg), Vit. B6 (3 mg), Vit. B12 (9 mcg), Folic acid (0.2 mg), Biotin (0.225 mg)
If body weight is up to 20 kg: Q10 ubiquinol, 50 mg b.i.d. Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (1.05 mg), Vit. B2 (1.2 mg), Niacin (9 mg), Pantothenic acid (4.5 mg), Vit. B6 (1.5 mg), Vit. B12 (4.5 mcg), Folic acid (0.1 mg), Biotin (0.1125 mg) If body weight is above 20 kg: Q10 ubiquinol, 100 mg b.i.d. Vitamin E 30 mg b.i.d. Multivitamin B complex b.i.d., including Vit. B1 (2.1 mg), Vit. B2 (2.4 mg), Niacin (18 mg), Pantothenic acid (9 mg), Vit. B6 (3 mg), Vit. B12 (9 mcg), Folic acid (0.2 mg), Biotin (0.225 mg)