A pilot trial with clenbuterol in spinal and bulbar muscular atrophy (SBMA).

• Conditions: spinal and bulbar muscular atrophy (SBMA); MedDRA version: 15.0Level: HLGTClassification code 10029317Term: Neuromuscular disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 15.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 15.0Level: LLTClassification code 10047868Term: Weakness of limbsSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 15.0Level: PTClassification code 10013969Term: Dyspnoea at restSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-022558-18-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI PADOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-28
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1) Genetically confirmed SBMA male patients with more than one of the following symptoms: muscle weakness, muscle atrophy, bulbar palsy or hand tremor. 2) Patients able to walk independently along a flat corridor with or without the of a cane or similar equipment. 3) Patients who were 30 to 70 years old at the time of informed consent 4) Patients who gave written informed consent.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) documented cardiac disease. 2) documented hypersensibility to beta2 agonists.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified