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

Angelman Syndrome Clinical Trial

— A-MANECE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056665
• Other study ID #: A-MANECE
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2014
• Last updated: October 19, 2015
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angelman Syndrome
• Syndrome

Intervention

Drug:
• MINOCYCLINE
Pill Minocycline 50 mg capsule
• PLACEBO (for Minocycline)
Pill manufactured to mimic Minocycline 50 mg capsule

Locations

Country	Name	City	State
Spain	Puerta de Hierro University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased on the equivalent age of development	Increased on the equivalent age of development, obtained through Development Scale R Merrill-Palmer (MP-R)	8, 16 and 24 weeks	No
Secondary	Improved specific cognitive, language and communication, motor development, social-emotional and adaptive behavior	Improved specific cognitive, language and communication, motor development, social-emotional and adaptive behavior obtained through Development Scale R Merrill-Palmer (MP-R)	8, 16 and 24 weeks	No
Secondary	Improvement of EEG.	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	8, 16 and 24 weeks	No
Secondary	Safety and tolerability	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.	8, 16 and 24 weeks	Yes
Secondary	Clinical Global impression (CGI)	Improvement of CGI. . Measure based on changes in the Clinical Global Impression through the perception of parents or guardians, you neurologists and therapist	8, 16 and 24 weeks	No