Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS

Summary

This is a Phase III, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS).

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

Tauroursodeoxycholic Acid

* Tauroursodeoxycholic acid (TUDCA) 250 mg capsules * Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal * Mode of administration: orally * Duration: 18 months

DRUG

Placebo

* Placebo 250 mg capsules * Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal * Mode of administration: orally * Duration: 18 months

Sponsors & Collaborators

• University of Ulm

  collaborator OTHER

• University of Sheffield

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• University of Dublin, Trinity College

  collaborator OTHER

• Bruschettini S.r.l.

  collaborator UNKNOWN

• Istituto Superiore di Sanità

  collaborator OTHER

• Motor Neurone Disease Association

  collaborator UNKNOWN

• European Commission

  collaborator OTHER

• Humanitas Mirasole SpA

  lead OTHER

Principal Investigators

• Alberto Albanese, MD · Humanitas Mirasole SpA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-22

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Belgium
• France
• Germany
• Ireland
• Italy
• Netherlands
• United Kingdom

Study Locations