Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)
- Registry ID
- EUCTR2011-002379-40
- Source registry
- EUCTR
- Status
- Prematurely Ended
- Phase
- PHASE2
- Sponsor
- Novartis Pharma Services AG
- Start date
- 2012-01-09
- Last update
- 2026-08-16
Conditions
Summary
To evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with FXS as assessed by:
• Incidence and severity of adverse events and serious adverse events
• Changes in vital signs, laboratory assessments, and ECGs
• Monitoring the hypothalamic-pituitary-adrenal/thyroid axis function and childhood developmental milestones
Locations
- , , Germany
- , , Spain
- , , Netherlands
- , , France
- , , Denmark
- , , Sweden
- , , Italy
- , , Belgium
- , , UK
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