Open-label study to evaluate the efficacy and tolerability of orally administered rosiglitazone in patients with progressive bone Fibrodysplasia (FOP)
- Conditions
- Fibrodysplasia Ossificans Progressive (FOP) is a rare genetically based disability, characterized by progressive heterotopic ossification, usually associated with congenital malformation of the toes.MedDRA version: 14.1Level: HLGTClassification code 10028393Term: Musculoskeletal and connective tissue disorders NECSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-002516-85-IT
- Lead Sponsor
- A.O. UNIVERSITARIA INTEGRATA DI VERONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
·patients of both sexes, older than 18 ·patients affected by FOP genetically confirmed ·patients with a joint mobility limitation > grade 2 (on a scale of 4 points) on at least one joint ·written informed consent signed by the patient or by a legally acceptable representative
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
·Patients affected by Bone Fibrodysplasia other than FOP ·Patients affected by heart failure, ischemic heart disease or with impaired liver function (ALT> 2 times the upper limit of normal) ·Patients under 18 ·Known hypersensitivity to the drug or the excipients 3.Pregnant or lactating women 4.alcoholism 5.drug dependence
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method