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Clinical trial

A Randomized, Double-blind, Parallel Group, Single Centre, Phase 1b/2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Orally Administered Doses of Enoxacin (200mg Twice Daily, 400mg Twice Daily and 600mg Twice Daily) in Adults With Amyotrophic Lateral Sclerosis

ID
Name
REALS-1
Description
The study will assess the safety of the drug enoxacin at specific dose levels in adults with ALS.
Trial arms
Trial start
2021-03-26
Estimated PCD
2023-11-15
Trial end
2023-11-15
Status
Completed
Phase
Early phase I
Treatment
Enoxacin
Oral 200mg tablet
Arms:
Enoxacin 200mg twice daily, Enoxacin 400mg twice daily, Enoxacin 600mg twice daily
Placebo
Oral tablet
Arms:
Enoxacin 200mg twice daily, Enoxacin 400mg twice daily
Size
8
Primary endpoint
Incidence of adverse events (AEs) and serious adverse events (SAEs)
From baseline (prior to dosing on day 1 of dosing) to 14 day +/- 2 day follow up visit
Incidence of abnormalities in clinical laboratory assessments
From baseline (prior to dosing on day 1 of dosing) to 14 day +/- 2 day follow up visit
Incidence of abnormalities in vital signs
From baseline (prior to dosing on day 1 of dosing) to 14 day +/- 2 day follow up visit
Incidence of abnormalities in physical and neurological examinations
From baseline (prior to dosing on day 1 of dosing) to 14 day +/- 2 day follow up visit
Incidence of abnormalities in electrocardiograms (ECGs)
From baseline (prior to dosing on day 1 of dosing) to 14 day +/- 2 day follow up visit
Ability of participants to remain on their assigned dose for the full 30 day treatment period
From the beginning (day 1) to the end (day 30) of the 30 day treatment period
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}
Updated at
2024-01-26

1 organization

2 products

1 indication

Organization
McGill University
Product
Enoxacin
Indication
Amyotrophic lateral sclerosis
Product
Placebo