A randomised, controlled phase 1 study to investigate the safety and efficacy of orally administered squalamine in subjects with Motor Neuron Disease

Phase 1

Completed

• Conditions: Motor Neuron Disease; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12619000375156
• Lead Sponsor: Wesley Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-11
• Study Completion: 2019-11-19
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Clinically definite or clinically probable MND defined according to the revised El Escorial criteria
-Age >18 years
-Provision of informed consent from the patient
-Willingness to give written informed consent and willingness to comply with the study

Exclusion Criteria

-Inability of patient to provide consent
-Inability to swallow capsules
-Participation in another/other clinical trials
-Prohibited concomitant medications: antibiotics, probiotics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ew adverse events (AEs), e.g. diarrhea and the status of existing AEs to assess safety. The Investigator may elicit symptoms using an open-ended question, followed by appropriate questions that clarify the patient’s verbatim description of AEs or change in concomitant medications. [Adverse events will be assessed every month for 12 months after commencement.];Physical examination will be conducted to assess safety and will include assessments of the participant’s general appearance, skin and lymphatics, EENT, cardiovascular system, respiratory system, abdomen/gastrointestinal system, and musculoskeletal system.[Physical examination will be assessed at screening, 3 months, 6 months, 9 months and 12 months after commencement.]