Clinical trial to evaluate ascorbic acid (vitamin C) and tocopherol (vitamin E) in combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndrome

Phase 1

• Conditions: Fragile x syndrome; MedDRA version: 19.0Level: PTClassification code 10017324Term: Fragile X syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2015-005460-42-ES
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-20
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of Fragile X syndrome by genetic testing of molecular biology, with full mutation result methylation.

2. Patients older than 2 years and under 9 years.

3. Signed the informed consent document before starting their participation in the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any advanced, severe or unstable disease.

2. Individuals with other psychiatric diagnosed as the first diagnosis.

3. Suffer serious medical problems in the last 12 months.

4. Previous treatment with 100 mg of vitamin E or C a day in the last month.

5. Any physical, mental or sensory impairments that prevent the assessment of effectiveness.

6. Hypersensitivity to any component of the preparation.

7. Liver failure or severe renal or previous history of kidney stones.

8. Any treatment regimen, including treatment with psychotropic drugs and / or anticonvulsant therapy that has not been stable for a period ? 4 weeks prior to randomization.

9. Current treatment with more than two psychoactive drugs, excluding medication used specifically for seizure control.

10. Hypoprothrombinemia secondary to vitamin K deficiency.

11. Sensitivity to any of the compounds of formula treatment.

12. Deficiency of G-6-PD.

13. Use of oral anticoagulants.

14. Suspicion of change the pharmacological or non-pharmacological interventions during the course of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified