Progressive external ophthalmoplegia. MedDRA version: 9.1 Level: LLT Classification code 10036802 Term: Progressive external ophthalmoplegia
Conditions
Interventions
Trade Name: AMBRAMICINA*16CPS 250MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tetracycline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharma
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy assessment of tetracycline in patients with progressive external ophthalmoplegia (PEO).;Secondary Objective: Safety assessment of tetracycline in patients with progressive external ophthalmoplegia (PEO).;Primary end point(s): Anaerobic lattacidemic threshold determined during the aerobic test on cycloergometer. | — |
Countries
Italy
Outcome results
None listed