A study of plasminogen in patients with amyotrophic lateral sclerosis and Parkinson’s disease

Not Applicable

Completed

• Conditions: Amyotrophic lateral sclerosis and Parkinson’s disease; Nervous System Diseases

• Registration Number: ISRCTN13974483
• Lead Sponsor: Talengen Institute of Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-01
• Study Start: 2023-01-27
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male and female patients =18 years of age with sporadic or familial ALS or PD
2. If taking riluzole and/or edaravone, must be on a stable dose prior to screening

Exclusion Criteria

1. History of a clinically significant non-ALS or PD neurologic disorder
2. Inability to swallow capsules.
3. Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus
4. Women who are pregnant, planning to become pregnant, or are breastfeeding.
5. Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or any form of oxygen supplementation.
6. Current or anticipated need for a diaphragm pacing system (DPS).
7. Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.
8. Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.

Study & Design

• Study Type: Interventional
• Study Design: Not specified