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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Clinical Trial, Placebo Compared to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome

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

Detailed Summary: STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME
Sponsor: Puerta de Hierro University Hospital

Current Primary Outcome: Increased on the equivalent age of development [ Time Frame: 8, 16 and 24 weeks ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improved specific cognitive, language and communication, motor development, social-emotional and adaptive behavior [ Time Frame: 8, 16 and 24 weeks ]
    Improved specific cognitive, language and communication, motor development, social-emotional and adaptive behavior obtained through Development Scale R Merrill-Palmer (MP-R)
  • Improvement of EEG. [ Time Frame: 8, 16 and 24 weeks ]
    Improvement of EEG. Measure based on changes in the background activity, type, number and duration of crises, widespread tendency to crises, paroxysmal abnormalities recorded types and the overall evaluation of clinical neurophysiologist
  • Safety and tolerability [ Time Frame: 8, 16 and 24 weeks ]
    a) Physical Examination b) Vital signs c) Laboratory Tests d) Adverse effects (AEs) list for treatment, laboratory values, values outside the reference range and descriptive statistics.
  • Clinical Global impression (CGI) [ Time Frame: 8, 16 and 24 weeks ]
    Improvement of CGI. . Measure based on changes in the Clinical Global Impression through the perception of parents or guardians, you neurologists and therapist


Original Secondary Outcome: Same as current

Information By: Puerta de Hierro University Hospital

Dates:
Date Received: February 5, 2014
Date Started: January 2014
Date Completion:
Last Updated: October 19, 2015
Last Verified: October 2014