Enoxacin for Amyotrophic Lateral Sclerosis (ALS)

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the safety of the drug enoxacin at specific dose levels in adults with ALS.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University
• Collaborators: Apotex Inc.; Weizmann Institute of Science
• Treatments: Enoxacin

Criteria

Inclusion Criteria:

• Diagnosis of familial or sporadic ALS

• Disease duration less than 36 months from symptom onset

• FVC of ≥ 50 percent predicted

• If female, is not breastfeeding and is not pregnant

• Has been on a stable dose of riluzole, or has not taken riluzole, for at least 30 days prior to screening

• If taking concomitant edaravone at study entry, must have completed at least one cycle of edaravone therapy prior to screening

• Not currently taking and has not taken for at least 30 days prior to screening any Theophylline containing medications, clozapine, or duloxetine

• No active infection in the 30 days prior to randomization

• Has not taken any fluoroquinolone antibiotics for at least 30 days prior to screening

Exclusion Criteria:

• Hypersensitivity/allergy to fluoroquinolones

• Diagnosed with another neurodegenerative disease

• Significant pulmonary disorder not attributed to ALS, central nervous system disorder associated with seizures, myasthenia gravis, active rheumatologic disease, tendinopathy, or any severe uncontrolled medical condition (other than ALS)

• Severe renal impairment or impaired liver function

• Baseline prolongation of QT interval/corrected QT interval (QTc) at screening, treatment with any agent that may prolong Qt/QTc interval, or history of any other at-risk other cardiac condition

• Currently enrolled in another clinical trial involving an experimental drug or device