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

Information source: Puerta de Hierro University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Angelman Syndrome

Intervention: MINOCYCLINE (Drug); PLACEBO (for Minocycline) (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Puerta de Hierro University Hospital

Official(s) and/or principal investigator(s):
Belen Ruiz-AntorĂ¡n, Principal Investigator, Affiliation: Clinical Pharmacology. Puerta de Hierro University Hospital

Summary

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

Clinical Details

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

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

Primary outcome: Increased on the equivalent age of development

Secondary outcome:

Improved specific cognitive, language and communication, motor development, social-emotional and adaptive behavior

Improvement of EEG.

Safety and tolerability

Clinical Global impression (CGI)

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

Eligibility

Minimum age: 6 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

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 and Contacts

Puerta de Hierro University Hospital, Madrid 28222, Spain
Additional Information

Starting date: January 2014
Last updated: October 28, 2014

Page last updated: August 23, 2015

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