INCLUSION BODY MYOSITIS MedDRA version: 6.1 Level: PT Classification code 10028289
Conditions
Interventions
Trade Name: SIVASTIN
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical Form: Powder a
Sponsors
ISTITUTO NEUROLOGICO "CARLO BESTA"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients affected by inclusion body myositis (diagnosis based on clinical, radiological and pathological data); males and females; aged between 18 and 80 years; patients able to give an informed consensus 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: Patients affected by a severe form of inclusion body myositis (disease duration > 10 years, severe dysphagia requiring an invasive nutritional support) or already treated with immunosuppressive drugs; patients in whom IVIG administration is not indicated (IgA deficiency, renal insufficiency, etc.); patients at high risk to develop rhabdomyolysis (patients with severe systemic diseases such as hepatopathies or thyroid dysfunction, patients in treatment with drugs that increase the risk of muscle toxicity, patients with CK basal levels five times higher than normal value); fertile women who intend to be pregnant or they are already pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of safety and tolerability of simvastatin, administered orally to patients with IBM;Secondary Objective: Evaluation of clinical efficacy of simvastatin, administered orally to patients with IBM;Primary end point(s): Improvement of functional indexes (IMACS definition: increase of at least 20% in three of core set measures; worsening of maximum 25% in no more than two core set measures is accepted, excluding the manual evaluation of muscle strength) | — |
Countries
Italy
Outcome results
None listed