Study to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome

Phase 2CompletedNCT02056665

Puerta de Hierro University Hospital32 enrolled

Overview

RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)

STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Angelman Syndrome

Interventions

MINOCYCLINEDRUG

Pill Minocycline 50 mg capsule

PLACEBO (for Minocycline)DRUG

Pill manufactured to mimic Minocycline 50 mg capsule

Eligibility

Sex: ALLMin age: 6 YearsMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female between 6 and 30 years old. * Clinical diagnosis of Angelman Syndrome and molecular confirmation of diagnosis. * The participant has an acceptable guardian can give consent on behalf of the participant. Exclusion Criteria: * Patients with hypersensitivity to tetracyclines. * Patients with impaired hepatic or renal function and in those with mainly drug allergy history. * Any other condition that in the opinion of the investigator is considered clinically relevant and that administration of minocycline contraindicated

Locations (1)

Puerta de Hierro University Hospital

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Increased on the equivalent age of development

Increased on the equivalent age of development, obtained through Development Scale R Merrill-Palmer (MP-R)