Status:
COMPLETED
Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborating Sponsors:
University of Palermo
Federico II University
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant, antiapoptotic and neuropr...
Detailed Description
Amyotrophic lateral sclerosis (ALS), or motor neuron disease (MND), is a rapidly progressive, fatal neurodegenerative condition characterized by loss of upper and lower motor neurons in the brain and ...
Eligibility Criteria
Inclusion
- 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);
- first symptoms of ALS by no more than 1.5 years;
- in treatment with steady regimen of riluzole 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.
Exclusion
- 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;
- subjects with bulbar onset;
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00877604
Start Date
June 1 2008
End Date
April 1 2012
Last Update
November 26 2014
Active Locations (1)
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1
Fondazione IRCCS Istituto neurologico Carlo Besta
Milan, Milan, Italy, 20133