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Fluoroquinolone Antibiotic

Enoxacin for Amyotrophic Lateral Sclerosis (REALS-1 Trial)

Phase 1 & 2
Waitlist Available
Led By Angela Genge, MD, FRCP
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (prior to dosing on day 1 of dosing) and at the 14 day +/- 2 day follow-up visit
Awards & highlights

REALS-1 Trial Summary

This trial will test the safety of a new drug for people with ALS.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

REALS-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the beginning (day 1) to the end (day 30) of the 30 day treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the beginning (day 1) to the end (day 30) of the 30 day treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability of participants to remain on their assigned dose for the full 30 day treatment period
Incidence of abnormalities in clinical laboratory assessments
Incidence of abnormalities in electrocardiograms (ECGs)
+3 more
Secondary outcome measures
Enoxacin
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score at baseline and at the end of the follow-up period
Area under the plasma concentration-time curve extrapolated to infinity (AUC 0-inf) of enoxacin after administration on day 1 and 30
+7 more
Other outcome measures
Ability of enoxacin to modulate the expression of one or more miRNA species in cerebrospinal fluid (CSF) and/or plasma

REALS-1 Trial Design

3Treatment groups
Experimental Treatment
Group I: Enoxacin 600mg twice dailyExperimental Treatment1 Intervention
Enoxacin 600mg twice daily (one dose in the morning and one dose in the evening) for 30 days, except day 1 and day 30 when only the morning dose will be taken. Participants will take 3 active 200mg enoxacin tablets per dose.
Group II: Enoxacin 400mg twice dailyExperimental Treatment2 Interventions
Enoxacin 400mg twice daily (one dose in the morning and one dose in the evening) for 30 days, except day 1 and day 30 when only the morning dose will be taken. Participants will take 2 active 200mg enoxacin tablets and 1 placebo tablet per dose.
Group III: Enoxacin 200mg twice dailyExperimental Treatment2 Interventions
Enoxacin 200mg twice daily (one dose in the morning and one dose in the evening) for 30 days, except day 1 and day 30 when only the morning dose will be taken. Participants will take 1 active 200mg enoxacin tablet and 2 placebo tablets per dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoxacin
2021
Completed Phase 2
~10
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor
394 Previous Clinical Trials
998,373 Total Patients Enrolled
4 Trials studying Amyotrophic Lateral Sclerosis
1,025 Patients Enrolled for Amyotrophic Lateral Sclerosis
Weizmann Institute of ScienceOTHER
56 Previous Clinical Trials
39,382 Total Patients Enrolled
Apotex Inc.Industry Sponsor
8 Previous Clinical Trials
29,012 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current count of participants engaged in this trial?

"Affirmative. Clinicaltrials.gov data reveals that this experimental trial, launched on March 26th 2021, is actively recruiting volunteers. A total of 36 participants are needed from one designated medical facility."

Answered by AI

What prior investigations have been conducted on Enoxacin?

"At the present moment, there is only one running clinical trial investigating Enoxacin. This phase 3 research has yet to be concluded and takes place mainly in Montreal, Quebec with a single additional location."

Answered by AI

Does this experiment constitute a pioneering endeavor?

"Apotex Inc. initiated the research into Enoxacin in 2021, which saw a trial of 36 participants. This led to Phase 1 and 2 drug approval stages being passed successfully. There is currently one active study sponsored by Apotex Inc.."

Answered by AI

Does this trial have any upper age limit for participants?

"This medical experiment requires patients to be between 18 and 85 years old. Separately, there are 44 trials for minors and 395 studies targeting older adults."

Answered by AI

Am I eligible to join this trial?

"This trial is recruiting 36 patients with amyotrophic lateral sclerosis, aged 18 to 85. To be eligible they must have a familial or sporadic ALS diagnosis, FVC of at least 50 percent predicted, not currently breastfeeding/pregnant (if female), been on riluzole for 30 days, completed one cycle of edaravone if applicable, not taking theophylline-containing meds or clozapine and duloxetine in the past month, no active infections recently and abstained from fluoroquinolones for 30 days prior to randomisation."

Answered by AI

Is the enrollment process open for participants in this investigation?

"As recorded on clinicaltrials.gov, this medical research is currently enrolling participants. It was initially announced on March 26th 2021 and has been up to date as recently as August 10th 2022."

Answered by AI
Recent research and studies
~2 spots leftby Apr 2025