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EXPLAIN -FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes

NCT01711606 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2016-03-03

No results posted yet for this study

Summary

This prospective observational study (registry) on Fragile X syndrome (FXS) is designed to evaluate characteristics, management and patient and caregiver-related outcomes the quality of life of Families and patients with FXS and to collect epidemiological and health economic data.

* EXPLAIN will report current and comprehensive data onEpidemiology data on fragile X syndrome
* Characterisation of the phenotype of FXS patients
* Description of patient characteristics (demographics, family history, comorbidity, education, working situations, care situations, insurance status)
* Documentation of therapeutic interventions
* Recording and assessment of psychosocial parameters (possibly also inclusion of family members, carers)
* quality of life of the carer and if possible the patient
* Health economic parameters and consumption of resources

Conditions

  • Fragile-X Syndrome

Sponsors & Collaborators

Principal Investigators

  • Frank Hässler, MD · Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter, Gehlsheimer Straße 20, D- 18147 Rostock

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01711606 on ClinicalTrials.gov