Study Purpose:
The study will assess the safety of the drug enoxacin at specific dose levels in adults with ALS.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Enoxacin, Placebo
Placebo:
Yes
Phase:
Phase 1/Phase 2
Study Chair(s)/Principal Investigator(s):
Angela Genge, MD, FRCP, McGill University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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 dose, participants will be assessed for safety measures and blood will be collected to assist with the determination of enoxacin pharmacokinetics (PK) and pharmacodynamics (PD). On day 1 and day 30 of dosing, participants will only take one dose of study medication (the morning dose) to assist with determination of enoxacin single dose PK over a 24-hour period. A lumbar puncture (LP) to collect cerebrospinal fluid (CSF) for PD assessments will occur on day 1 and day 30.
Study Sponsor:
McGill University
Estimated Enrollment:
36
Estimated Study Start Date:
03 / 26 / 2021
Estimated Study Completion Date:
05 / 01 / 2023
Posting Last Modified Date:
03 / 23 / 2023
Date Study Added to neals.org:
04 / 12 / 2021
Minimum Age:
18 Years
Maximum Age:
85 Years
Inclusion Criteria:- 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 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
Montreal Neurological Institute-Hospital
Montreal, Quebec
H3A 2B4
Canada