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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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

Conditions

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Angelman Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MINOCYCLINE 8 weeks

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.

Group Type EXPERIMENTAL

MINOCYCLINE

Intervention Type DRUG

Pill Minocycline 50 mg capsule

PLACEBO (for Minocycline)

Intervention Type DRUG

Pill manufactured to mimic Minocycline 50 mg capsule

PLACEBO 8 weeks

Pill manufactured to mimic Minocycline 50 mg capsule

Group Type PLACEBO_COMPARATOR

MINOCYCLINE

Intervention Type DRUG

Pill Minocycline 50 mg capsule

PLACEBO (for Minocycline)

Intervention Type DRUG

Pill manufactured to mimic Minocycline 50 mg capsule

MINOCYCLINE 16 weeks

Duration of treatment: 16 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.

Group Type EXPERIMENTAL

MINOCYCLINE

Intervention Type DRUG

Pill Minocycline 50 mg capsule

Interventions

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MINOCYCLINE

Pill Minocycline 50 mg capsule

Intervention Type DRUG

PLACEBO (for Minocycline)

Pill manufactured to mimic Minocycline 50 mg capsule

Intervention Type DRUG

Other Intervention Names

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Commercial name: Aknemin 50 Active substance: MINOCYCLINE Administration routes: Oral use Commercial name: NA Non Active substance: Administration routes: Oral use

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No