Status:
UNKNOWN
Q10 Ubiquinol in Autism Spectrum Disorder and in Phelan-McDermid Syndrome.
Lead Sponsor:
Antonio Persico
Collaborating Sponsors:
Associazione Italiana Sindrome di Phelan-McDermid (AISPHEM)
University of Bari
Conditions:
Autism Spectrum Disorder
Phelan-McDermid Syndrome
Eligibility:
All Genders
2-40 years
Phase:
NA
Brief Summary
This double-blind, cross-over, randomized, controlled trial (RCT) has the aim of evaluating the effectiveness of a metabolic support therapy in two cohorts of patients with idiopathic Autism Spectrum ...
Detailed Description
Autism Spectrum Disorder (ASD) is a clinically and genetically heterogeneous collection of different conditions, sharing socio-communicative deficits, repetitive behaviors, restricted interests, and d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04312152
Start Date
March 9 2019
End Date
August 31 2023
Last Update
March 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Interdipartimental Program "Autismo 0-90" at "G. Martino" Universitary Hospital
Messina, ME, Italy, I-98125