Seguridad, tolerabilidad y eficacia a largo plazo de AFQ056 en pacientes adultos con síndrome X frágil

Phase 1

Active, not recruiting

• Conditions: Fragile X Syndrome; MedDRA version: 14.1Level: PTClassification code 10017324Term: Fragile X syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001952-12-ES
• Lead Sponsor: ovartis Farmacéutica S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Study Completion: 2014-09-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

- Must have been enrolled in Studies CAFQ056A2204 or CAFQ056A2212
- Has a caregiver who spends, on average, at least 6 hours per day with
the patient , who is willing to and capable of supervising treatment,
providing input into efficacy and safety assessments, and accompanying
the patient to study visits.
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any advanced, severe or unstable disease
- History of severe self-injurious behavior
- History of uncontrolled seizure disorder or resistant to therapy within
the past 2 years (Patients who are clinically stable under anti-convulsant
therapy for the past 2 years are not excluded)
- History of clinically significant allergies requiring hospitalization or
non-inhaled corticosteroid therapy (asthma, anaphylaxis, etc.)
- Any treatment regimen, including psychotropic and/or anticonvulsant
therapy that has not been stable for ? 6 weeks prior to randomization
- Current treatment with more than two psychoactive medications,
excluding medication used specifically for seizure control
- Using (or used within 6 weeks before randomization) concomitant
medications that are potent inhibitors or inducers of CYP3A4
- Using glutamatergic agents (riluzole, memantine, etc.) or lithium
within 6 weeks of randomization
- Planning to initiate or change pharmacologic or non-pharmacologic
interventions during the course of the study
Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified