A low molecular weight dextran sulphate, ILB®, for the treatment of amyotrophic lateral sclerosis (ALS): An open-label, single-arm, single-centre, phase II trial.
Venkataramanan SrinivasanVictoria HomerDarren BartonAbigail Clutterbuck-JamesSiân JenkinsClaire PotterKristian BrockAnn LoganDonna SmithLars BruceZsuzsanna NagySimon P BachPublished in: PloS one (2024)
EudraCT: 2018-000668-28. clinicaltrials.gov: NCT03705390. This trial adheres to the principles of GCP in the design, conduct, recording and reporting of clinical trials as listed in part 2, "Conditions and Principles which apply to all Clinical Trials" under the header "Principles based on Articles 2 to 5 of the EU GCP Directive" in the Medicines for Human Use Clinical Trials Regulations (as amended in SI 2006/1928). For clarity, the study did not conform to all aspects of the International Conference on Harmonisation (ICH) E6 R2 Guidelines for GCP (also known as 'ICH GCP'). Of note, we did not use an external database, perform 100% source data verification, and only primary outcome data were analysed in parallel by a second, independent statistician.
Keyphrases
- clinical trial
- amyotrophic lateral sclerosis
- phase ii
- open label
- phase iii
- electronic health record
- study protocol
- endothelial cells
- big data
- double blind
- clinical practice
- emergency department
- data analysis
- placebo controlled
- combination therapy
- room temperature
- machine learning
- artificial intelligence
- sewage sludge