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Completed

NCT Number: NCT02056665

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

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

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Key information

Conditions

Angelman Syndrome Abnormalities, Multiple Central Nervous System Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Imprinting Disorders Movement Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases cyclopia sequence

Age range

6 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Puerta de Hierro University Hospital

Madrid, 28222, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minocycline

Drug

Pill Minocycline 50 mg capsule

Other names: Commercial name: Aknemin 50, Active substance: MINOCYCLINE, Administration routes: Oral use

PLACEBO (for Minocycline)

Drug

Pill manufactured to mimic Minocycline 50 mg capsule

Other names: Commercial name: NA, Non Active substance:, Administration routes: Oral use

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

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

Acronym: A-MANECE

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2014
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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