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

Brief Title

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

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 Description

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

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Increased on the equivalent age of development

Secondary Outcome

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

Condition

Angelman Syndrome

Intervention

MINOCYCLINE

Study Arms / Comparison Groups

 MINOCYCLINE 8 weeks
Description:  Duration of treatment: 8 weeks
Patients <35 kg. 100 mg / day. Administered at a dose of one capsule of 50 mg breakfast and dinner.
Patients 35 - 50 kg. 150 mg / day. Administered at a dose of 2 capsules of 50 mg breakfast and 1 capsule of 50mg dinner.
Patients > 50 kg. 200 mg / day. Administered at a dose of two capsules of 50 mg of breakfast and dinner.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

32

Start Date

January 2014

Completion Date

November 2014

Primary Completion Date

September 2014

Eligibility 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
      

Gender

All

Ages

6 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Belen Ruiz-Antorán, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT02056665

Organization ID

A-MANECE


Responsible Party

Principal Investigator

Study Sponsor

Puerta de Hierro University Hospital


Study Sponsor

Belen Ruiz-Antorán, Principal Investigator, Clinical Pharmacology. Puerta de Hierro University Hospital


Verification Date

October 2014