Study to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome (A-MANECE)
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ClinicalTrials.gov Identifier: NCT02056665 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Last Update Posted : October 21, 2015
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Condition or disease | Intervention/treatment | Phase |
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Angelman Syndrome | Drug: MINOCYCLINE Drug: PLACEBO (for Minocycline) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Trial, Placebo Compared to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: MINOCYCLINE 8 weeks
Duration of treatment: 8 weeks
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Drug: MINOCYCLINE
Pill Minocycline 50 mg capsule
Other Names:
Drug: PLACEBO (for Minocycline) Pill manufactured to mimic Minocycline 50 mg capsule
Other Names:
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Placebo Comparator: PLACEBO 8 weeks
Pill manufactured to mimic Minocycline 50 mg capsule
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Drug: MINOCYCLINE
Pill Minocycline 50 mg capsule
Other Names:
Drug: PLACEBO (for Minocycline) Pill manufactured to mimic Minocycline 50 mg capsule
Other Names:
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Experimental: 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. |
Drug: MINOCYCLINE
Pill Minocycline 50 mg capsule
Other Names:
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- 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)
- 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)
- 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
- 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.
- 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

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Ages Eligible for Study: | 6 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056665
Spain | |
Puerta de Hierro University Hospital | |
Madrid, Spain, 28222 |
Principal Investigator: | Belen Ruiz-Antorán | Clinical Pharmacology. Puerta de Hierro University Hospital |
Responsible Party: | BELEN RUIZ-ANTORAN, DR, Puerta de Hierro University Hospital |
ClinicalTrials.gov Identifier: | NCT02056665 |
Other Study ID Numbers: |
A-MANECE |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | October 21, 2015 |
Last Verified: | October 2014 |
Angelman Syndrome EFFICACY SAFETY |
MINOCYCLINE Pediatrics population Rare diseases |
Angelman Syndrome Syndrome Disease Pathologic Processes Movement Disorders Central Nervous System Diseases Nervous System Diseases |
Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Minocycline Anti-Bacterial Agents Anti-Infective Agents |