Stroke in Young Fabry Patients (sifap2): Characterization of the Stroke Rehabilitation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00413595
• Date of registration: 19/12/2006
• Primary sponsor: University of Rostock
• Public title: Stroke in Young Fabry Patients (sifap2): Characterization of the Stroke Rehabilitation sifap2
• Scientific title: Stroke in Young Fabry Patients (sifap2): Characterization of the Stroke Rehabilitation in Young Patients With Fabry Disease: An Epidemiological, International, Multicenter Prognosis Study
• Date of first enrolment: April 2007
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00413595
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

Austria, Belgium, Croatia, Denmark, Finland, France, Georgia, Germany, Ireland, Italy, Poland, Portugal, Spain, United Kingdom

Contacts

• Name: Arndt Rolfs, Prof., MD

• Name: Arndt Rolfs, Prof., MD
• Affiliation: University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients (18 - 55 years of age) with an acute cerebrovascular event (CVE) of
any etiology defined as patients having an ischemic stroke or transient ischemic
attack

- Genetic diagnosis (a-galactosidase defect)of Fabry disease

- Written informed consent from patient

Exclusion Criteria:

- No proven Fabry disease

- Participating in an other clinical trial with any investigational new drug or medical
device

- Contraindication to any of the diagnostic procedures like e.g. MRI investigation

- Patient has been pretreated with Enzyme Replacement Therapy at the date of informed
consent of sifap2



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cerebrovascular Accident

Fabry Disease

Intervention(s)

Other: No intervention

Primary Outcome(s)

Determination of the relapse rate of acute cerebrovascular events with clinical relevance in patients with different prophylactic approaches [Time Frame: 54 months study duration]

Secondary Outcome(s)

Beck Depression Inventory II (BDI II) [Time Frame: 54 months study duration]

Brief Pain Inventory (BPI) [Time Frame: 54 months study duration]

Functional neurological deficits measured by the Mini Mental State Examination (MMSE) [Time Frame: 54 months study duration]

Habi test (only in Austrian and German centers) [Time Frame: 54 months study duration]

Number of acute CVEs without clinical significance but with obvious signs in MRI diagnosis [Time Frame: 54 months study duration]

Quality of Life measured with the SF-36 [Time Frame: 54 months study duration]

Rostocker Kopfschmerzfragen-Komplex (RoKoKo) (only in Austria and Germany) [Time Frame: 54 months study period]

Trail Making Test (TMT) [Time Frame: 54 months study duration]

Secondary ID(s)

II PV04/2006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shire Human Genetic Therapies, Inc.