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Minocycline in Angelman Syndrome
NCT02056665Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2014
- Primary completion
- Sep 2014
- Countries
- 1
- Sponsor
- Hospital Universitario Puerta de Hierro Majadahonda
- Modality
- Small Molecules
- Drugs
- minocycline
- Conditions
- Angelman syndrome (AS)
01
Overview
Phase 2, randomised, double-blind trial of minocycline in Angelman syndrome (AS) (3 arms), sponsored by Hospital Universitario Puerta de Hierro Majadahonda. Primary endpoint: Increased on the equivalent age of development at 24 weeks. Started Jan 2014; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Minocycline Sequence
Minocycline for 8 weeks then Placebo for 8 weeks (Crossover)
Placebo Sequence
Placebo for 8 weeks then Minocycline for 8 weeks (Crossover)
Minocycline Continuous
Minocycline for 16 weeks
03
Who it enrols
Patients aged 6-30 years with a clinical and molecular diagnosis of Angelman Syndrome, excluding those with hypersensitivity to tetracyclines or impaired hepatic/renal function.
04
Endpoints
Primary
Increased on the equivalent age of development
Secondary
Improved specific cognitive, language and communication, motor development, social-emotional and adaptive behavior
Improvement of EEG
Safety and tolerability
Clinical Global impression
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