STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)

Conditions: Angelman Syndrome
MedDRA version: 16.0Level: PTClassification code 10049004Term: Angelman's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-002154-67-ES

Lead Sponsor: Dra. Cristina Avendaño Solá

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) Male or female between 6 and 30 years old.
(2) Clinical diagnosis of Angelman Syndrome and molecular confirmation of diagnosis.
(3) The participant has an acceptable guardian can give consent on behalf of the participant.
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
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) Patients with hypersensitivity to tetracyclines.
(2) Patients with impaired hepatic or renal function and in those with mainly drug allergy history.
(3) Any other condition that in the opinion of the investigator is considered clinically relevant and that administration of minocycline contraindicated ..

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the efficacy of Mynocicline in the treatment of patients affected of Angelman Syndrome, in terms of increase in the age of development;Secondary Objective: 1) To compare mynocicline efficay vs placebo in terms of: <br>-specific improvement of cognitive development, language and comunication, motor development, social-emotional development and adaptative conduct.<br>- improvement of adaptive behaviour, , the ability to adapt to changes in their environment, learn new skills everyday and the level of independence<br>2) To evaluate the safety of mynociclne;Primary end point(s): Increased on the equivalent age of development, obtained through Development Scale R Merrill-Palmer (MP-R);Timepoint(s) of evaluation of this end point: 8, 16 and 24 weeks

Secondary Outcome Measures