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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 October 2012 |
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Main ID: |
EUCTR2010-022558-18-IT |
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Date of registration:
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28/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A pilot trial with clenbuterol in spinal and bulbar muscular atrophy (SBMA).
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Scientific title:
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A pilot trial with clenbuterol in spinal and bulbar muscular atrophy (SBMA). |
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Date of first enrolment:
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11/10/2010 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022558-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
Number of treatment arms in the trial: 1
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
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Health Condition(s) or Problem(s) studied
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spinal and bulbar muscular atrophy (SBMA)
MedDRA version: 15.0
Level: HLGT
Classification code 10029317
Term: Neuromuscular disorders
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 15.0
Level: SOC
Classification code 10029205
Term: Nervous system disorders
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 15.0
Level: LLT
Classification code 10047868
Term: Weakness of limbs
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0
Level: PT
Classification code 10013969
Term: Dyspnoea at rest
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Trade Name: MONORES*30CPR 20MCG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Clenbuterol
Concentration unit: µg microgram(s)
Concentration number: 20-
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Primary Outcome(s)
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Main Objective: The main objective of the study is to investigate the safety and tolerability of clenbuterol of the SBMA
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Primary end point(s): change from the baseline of the walk distance (mt) in six minutes (6-min walk test) at 12 months.
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Secondary Objective: NA
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Secondary ID(s)
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2010-022558-18
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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