Simvastatin treatment in inclusion body myositis (IBM) - ND

Conditions: INCLUSION BODY MYOSITIS
MedDRA version: 6.1Level: PTClassification code 10028289

Registration Number: EUCTR2007-004359-12-IT

Lead Sponsor: ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures