Efficacy assessment of tetracycline in patients with progressive external ophthalmoplegia. - TETRA-PEO
- Conditions
- Progressive external ophthalmoplegia.MedDRA version: 9.1Level: LLTClassification code 10036802Term: Progressive external ophthalmoplegia
- Registration Number
- EUCTR2007-005274-31-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA PISANA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
a. PEO or PEO plus, confirmed by histopathologic reports (presence of ragged red fibres in muscular biopsy), biochemical reports (compromising of mitochondrial respiration) and molecular reports (deletions or mutations of mtDNA); b. Age from 18 years to 68 years; c. Negative pregnancy test in fertile women.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
a. Poor compliance with previous treatments; b. Patients that partecipate in other clinical trial; c. Patients with serious organ's diseases (cardiologic, neurologic, neoplastic, pneumologic and endocrinologic disease); d. Patients with history of sensitivity or intolerance of tetracycline and patients with concomitant diseases that contraindicate tetracycline administration (myasthenia gravis, systemic erythematus lupus, renal or hepatic diseases).
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