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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: |
EUCTR2007-001592-10-IT |
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Date of registration:
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15/01/2008 |
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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 randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholic
acid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALS
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Scientific title:
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A randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholic
acid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALS |
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Date of first enrolment:
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15/02/2008 |
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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:2007-001592-10 |
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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: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
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:
Caucasian male or female out-patients;
aged 18 to 75 years inclusive;
diagnosis of ?probable? or ?definite? amyotrophic lateral sclerosis according to the El Escorial revised criteria (1);
experiencing disease progression in the last 3 months;
first symptoms of ALS by no more than 1.5 years;
in treatment with steady regimen of riluzole and vitamin E for a minimum of 3 months before study entry, and desiring its continuation;
FVC ≥ 75% of predicted;
no conditions known to be contraindications to the use of TUDCA;
written informed consent.
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:
subjects who underwent tracheostomy;
subjects who underwent resection of gall bladder;
subjects with signs of conduction blocks of motor nerves, sensory nerves or both on nerve conduction study;
subjects with clinical signs of dementia;
subjects with active peptic ulcer;
subjects with active malignancy;
female subjects who are pregnant or lactating
subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening
employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of
that investigator or study centre.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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AMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1
Level: LLT
Classification code 10002026
Term: Amyotrophic lateral sclerosis
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Intervention(s)
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Product Name: Tauroursodeoxycholic acid
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: Tauroursodeoxycholic acid
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Prolonged-release capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Primary evaluation parameter will be the ALSFRS-R (2) according to the consensus conference on designing and implementing clinical
trials in ALS (3).
Primary endpoint will be the ALSFRS-R slope during the treatment period as compared to the lead-in period
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Secondary Objective: Secondary parameters will include FVC%, the SF-36 quality of life rating scale, Time to Tracheostomy from starting of study medication
dosing (if appropriate), Survival Time from starting of study medication dosing (if appropriate) and the number of patients
showing an improvement ≥ 15% in ALSFRS-R slope as compared to the lead-in period (responders).
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Main Objective: To assess if the addition of TUDCA to the conventional therapy can improve the therapeutic outcome in patients affected by ALS (ALSFRS-R).
Safety will be assessed for all subjects, for the entire duration of the study.
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Secondary ID(s)
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TUDCA 20071
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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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