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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03826940
Date of registration: 23/01/2019
Prospective Registration: Yes
Primary sponsor: University of Coimbra
Public title: From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1 ASD/NF1inhib
Scientific title: Linking Inhibition From Molecular to Systems and Cognitive Levels: a Preclinical and Clinical Approach in Autism Spectrum Disorders and Neurofibromatosis.
Date of first enrolment: February 19, 2019
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03826940
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Portugal
Contacts
Name:     Miguel Castelo-Branco, MD PhD
Address: 
Telephone:
Email: mcbranco@fmed.uc.pt
Affiliation: 
Name:     Miguel S Castelo-Branco, MD, PhD
Address: 
Telephone: +351 239488510
Email: mcbranco@fmed.uc.pt
Affiliation: 
Name:     Miguel S Castelo-Branco, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  ICNAS - Institute of Nuclear Sciences Applied to Health
Key inclusion & exclusion criteria

Inclusion Criteria:

- Positive diagnostic results for ASD in:

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

- Positive diagnostic results for NF1:

Clinical diagnosis based on the well-established clinical criteria

Exclusion Criteria:

- Global Intelligence Quotient < 80

- Associated medical condition such as epilepsy, neurologic conditions, genetic
syndromes, or other usual comorbidity in ASD and NF1 populations

- Medication capable of interfering with the intervention and/or study results

- Pregnancy

- Drug use and/or alcohol abuse

- Contra-indications to MR and TMS



Age minimum: 16 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Autism Spectrum Disorder
Neurofibromatosis 1
Intervention(s)
Drug: Lovastatin 60 MG
Drug: Placebos
Primary Outcome(s)
Neurochemical response changes to GABAergic stimulation [Time Frame: Through study completion, an average of 1 year]
Secondary Outcome(s)
Brain oscillations changes under sensory stimulation [Time Frame: Through study completion, an average of 1 year]
Cortical excitability changes under motor cortical stimulation [Time Frame: Through study completion, an average of 1 year]
Event-related potentials changes under sensory stimulation [Time Frame: Through study completion, an average of 1 year]
Motor evoked potentials changes under motor cortical stimulation [Time Frame: Through study completion, an average of 1 year]
Secondary ID(s)
CRU2C-ICNAS-001
FLAD Life Science 2020
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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