Safety and tolerability of Trimetazidine in amyotrophic lateral sclerosis (ALS)

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12620000945921
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-22
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Signed informed consent prior to the initiation of any study-specific procedures
2.Familial or sporadic ALS/MND, defined as clinically possible, probable, or definite as per the El Escorial criteria
3.Relative TRICALS risk profile between -6.0 to -2.0 (75% of patients with ALS/MND)
4.Metabolic index (defined as measured resting energy expenditure as a % of predicted resting energy expenditure) equal to or greater than 110%.
5.The use of riluzole will be permitted during the study. Participants taking riluzole must be on a stable dose for at least 30 days prior to the baseline visit, or stopped taking riluzole at least 30 days prior to the baseline visit.
6.Ability to swallow tablets
7.Able to lie with torso elevated at a 35 degree angle for 30 minutes without respiratory support
8.Aged over 18 years
9.Able to give informed consent (as judged by the investigator) and able to comply with all study visits and all study procedures

Exclusion Criteria

1.Unable to provide informed consent
2.History of, or current diagnosis of diabetes or medical condition that impacts whole body energy expenditure (e.g. Hashimoto’s, heart disease)
3.Tracheostomy or non-invasive ventilation (NIV) use > 22 hours per day
4.Inability to swallow tablets
5.Contraindication therapy
6.Evidence of malignant disease
7.Significant neuromuscular disease other than ALS/MND
8.Ongoing disease that may cause neuropathy
9.Pregnancy or breastfeeding
10.Deprivation of freedom by administrative or court order

Study & Design

• Study Type: Interventional
• Study Design: Not specified