Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis

Launched by FONDAZIONE I.R.C.C.S. ISTITUTO NEUROLOGICO CARLO BESTA · Apr 7, 2009

Keywords

ClinConnect Summary

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 spinal cord. The terms ALS and MND are often used inter-changeably to cover the different clinical syndromes, which include upper and lower motor neuron disorder, progressive bulbar palsy, and pseudo-polyneuritic form.

Degeneration of lower motor neurons (LMN) in the anterior horns of spinal cord and brainstem leads to progressive muscular atrophy and eventually to death within a few years due...

Gender

ALL

Eligibility criteria

• 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);
• • 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 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;
• • 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.