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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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19 March 2012 |
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Main ID: |
EUCTR2010-020257-13-IT |
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Date of registration:
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05/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS
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Scientific title:
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A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS |
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Date of first enrolment:
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30/07/2010 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020257-13 |
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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: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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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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Key inclusion & exclusion criteria
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Inclusion criteria:
In order to be included in this study, patients must meet all of the following criteria: 1. Can provide signed/dated Informed Consent; 2. Are a male or female patient 18-75 years of age; 3. Diagnosis of Amyotrophic Lateral Sclerosis according to EI Escorial Revised Criteria 4. Life expectancy of at least 6 months
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 are excluded from this study if they meet any of the following criteria: 1. Are unable or unwilling to understand study assessment or to cooperate with the study procedures as determined by the investigator 2. any contraindication to the use of eperisone 3. diagnosis of other neurological disease in addition to ALS 4. female subjects pregnant or lactating or plan to become pregnant during the course of the study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1
Level: SOC
Classification code 10029205
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Intervention(s)
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Trade Name: MYONAL*30CPR RIV 100MG
Pharmaceutical Form: Tablet
INN or Proposed INN: EPERISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: LIORESAL*50CPR 10MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Baclofen
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
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Primary Outcome(s)
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Secondary Objective: to assess the efficacy of eperisone for treatment of spasticity in ALS patients
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Primary end point(s): The primary outcome measure are: 1) the number of therapeutic failures (treatment stops for ineffectiveness and/or AEs); 2) improvement of spasticity at three months or greater as measured by Ashworth spasticity score.
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Main Objective: The two main objectives of the project to assess safety and tolerability of eperisone administration in ALS patients;
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Source(s) of Monetary Support
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Results
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Results available:
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