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Trial record 58 of 677 for:    amyotrophic lateral sclerosis

Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis (TUDCA-ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00877604
Recruitment Status : Completed
First Posted : April 8, 2009
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Collaborators:
University of Palermo
Federico II University
Information provided by (Responsible Party):
Alberto Albanese, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis
Interventions Drug: tauroursodeoxycholic acid (TUDCA)
Drug: Placebo
Enrollment 34
Recruitment Details Recruitment is started on eightth of october 2009, in medical clinics (Besta Institute in Milan, University II department of Neurology of Naples, University of Palermo department of Neurology).
Pre-assignment Details 34 patients enrolled, 5 of whom dropped out during the lead in phase.
Arm/Group Title TUDCA Placebo
Hide Arm/Group Description

tauroursodeoxycholic acid di-hydrate

tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year

excipient lactose

Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose

Period Title: Overall Study
Started 17 17
Completed 15 14
Not Completed 2 3
Arm/Group Title TUDCA Placebo Total
Hide Arm/Group Description

tauroursodeoxycholic acid di-hydrate

tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year

excipient lactose

Placebo: identical placebo by oral route at the same dosing schedule

Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
54.0  (12.2) 58.2  (12.9) 56.1  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
6
  35.3%
7
  41.2%
13
  38.2%
Male
11
  64.7%
10
  58.8%
21
  61.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 17 participants 17 participants 34 participants
17 17 34
1.Primary Outcome
Title The Proportion of Responder Patients in the Two Treatment Groups According the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)-R Slope.
Hide Description Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R slope during the treatment period as compared to the lead-in period.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TUDCA Placebo
Hide Arm/Group Description:

tauroursodeoxycholic acid di-hydrate

tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year

excipient lactose

Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose

Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: participants
13 6
2.Secondary Outcome
Title Forced Vital Capacity (FVC) %
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title SF-36 Quality of Life Rating Scale
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Tracheostomy From Starting of Study Medication Dosing (if Appropriate)
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Survival Time From Starting of Study Medication Dosing (if Appropriate)
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
6.Secondary Outcome
Title ALSFRS-R at Study End
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Incidence and Severity of Adverse Events, and Their Relationship to Treatment
Hide Description laboratory tests, patients’ reports and the investigator’s judgments
Time Frame 1 year
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Medical Research Council Scores for Right and Left Muscle Groups
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TUDCA Placebo
Hide Arm/Group Description

tauroursodeoxycholic acid di-hydrate

tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year

excipient lactose

Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose

All-Cause Mortality
TUDCA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TUDCA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TUDCA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alberto Albanese
Organization: Fondazione Istituto Neurologico Carlo Besta
Phone: +39 02 2392 4552
EMail: alberto.albanese@unicatt.it
Publications:
Layout table for additonal information
Responsible Party: Alberto Albanese, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT00877604     History of Changes
Other Study ID Numbers: TUDCA200701
EudraCT No.: 2007-001592-10
First Submitted: April 7, 2009
First Posted: April 8, 2009
Results First Submitted: October 31, 2014
Results First Posted: November 26, 2014
Last Update Posted: November 26, 2014