Status:
COMPLETED
Enoxacin for Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
McGill University
Collaborating Sponsors:
Weizmann Institute of Science
Apotex Inc.
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
The study will assess the safety of the drug enoxacin at specific dose levels in adults with ALS.
Detailed Description
Participants will be randomized to one of three doses of enoxacin (200, 400, or 600mg twice daily) for 30 days. On day 1, 7, 14, 21, and 30 of treatment and at a follow-up visit 14 days after the last...
Eligibility Criteria
Inclusion
- Diagnosis of familial or sporadic ALS
- 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
- 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
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04840823
Start Date
March 26 2021
End Date
November 15 2023
Last Update
January 26 2024
Active Locations (1)
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1
Montreal Neurological Institute-Hospital
Montreal, Quebec, Canada, H3A 2B4