ALS (Amyotrophic Lateral Sclerosis)Phase 1NCT04090684
Ciprofloxacin/Celecoxib Combination in Patients With ALS
A Phase 1 study testing Fixed dose combination Ciprofloxacin/Celecoxib in people with ALS (Amyotrophic Lateral Sclerosis), run by NeuroSense Therapeutics Ltd. at 1 site in United States.
Trial summary
This is an open label, off label study, to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability, routine disease progression measures (ALSFRS-R and Vital Capacity). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- Fixed dose combination Ciprofloxacin/Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 20 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
- Males or females between the ages of 18 and 75 years of age, inclusive
- Diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria) less than 5 years prior to baseline
- Patients may be on Riluzole and/or Edaravone; 30 days of stable use is required to make safety assessments more reliable
- Upright Forced Vital Capacity (FVC) ≥ 50% of predicted for age, height and sex at screening
- Patient is able to swallow tablets/ capsules
- A caregiver (if one is needed)
- Female patients must be post-menopausal (≥ 1 year) OR sterilized, OR if of childbearing potential (i.e., females who have had their first period unless they are anatomically and physiologically incapable to become pregnant), must have a negative pregnancy test, and agree to use contraceptive drugs or devices (e.g., diaphragm plus spermicide, or oral contraceptives) for the duration of the study and 10 weeks after the last treatment dose AND require male partners to use a condom during sexual intercourse
Who cannot join
- A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
- Any known clinically significant abnormal gastric mucosal initial gastroscopic of an erosion, ulcer or tumor or/and GI disorder
- Known history of impaired renal function.
- Known or suspected congestive heart and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
- Known history of QT/QTc prolongation, Torsade de pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome) and the use of concomitant medications that prolong the QT/QTc interval.
- Known or suspected diagnosis or family history of epilepsy
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- Presence at screening of any medically significant cardiac, pulmonary, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety data, including, but not limited to:
- Mean systolic blood pressure >180 mm Hg; mean diastolic blood pressure >100 mm Hg (measurements taken after few min rest) that persist on 3 successive measurements taken at least 2 minutes apart
- NYHA Class II or greater congestive heart failure
- Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
- Poorly controlled or brittle diabetes mellitus
- Cognitive impairment, related to ALS or otherwise, sufficient to impair the patient's ability to understand and/or comply with study procedures and provide informed consent
- Female who is pregnant or breastfeeding or with intention of becoming pregnant during the course of the study
- Any impairment or social circumstance that, in the opinion of the Investigator, would render the patient not suitable to participate in the study
- Patient, patient's parent(s), or patient's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study
- Patient is participating in (or plans to participate in) any other investigational drug trial, or plans to be exposed to any other investigational agent, device and/or procedure, from 30 days prior to Screening through study completion
Trial locations and contacts
1 site in 1 country.
United States1 site
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS
This is an open label, off label study, to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability, routine disease progression measures (ALSFRS-R and Vital Capacity).
Read the detailed description
Patients will be prescribed a fixed dose combination of Ciprofloxacin and Celecoxib to be taken twice daily, and will be monitored for safety and tolerability. Additionally, routine progression measures will be assessed.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Being tested
- Fixed dose combination Ciprofloxacin/Celecoxib
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed dose combination Ciprofloxacin/CelecoxibDrug
Also called PrimeC
Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day
| Study group | Role | What they receive |
|---|---|---|
| Fixed dose Ciprofloxacin and Celecoxib | Experimental | Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day Receives: Drug: Fixed dose combination Ciprofloxacin/Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with one or more treatment-emergent adverse events
Treatment emergent adverse event is any medical event associated with the drug
Measured: 15 months
Number of patients who discontinued treatment prematurely
Number of patients whose treatment is stopped prematurely for any reason
Measured: 15 months
Number of patients who discontinued treatment prematurely due to adverse events
Number of patients whose treatment is stopped prematurely specifically due to adverse events
Measured: 15 months
Number of patients with significant abnormal laboratory values
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start9 Dec 2019
- Primary completion27 Sep 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroSense Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Shefner, MD, PhD, Principal investigator, Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090684
- Sponsor's protocol ID
- NST001
- Status last verified
- Jan 2022
- First submitted
- 29 Aug 2019
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS
- ClinicalTrials.gov ID
- NCT04090684
- Acronym / sponsor ID
- NST001
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NeuroSense Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, off label study, to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability, routine disease progression measures (ALSFRS-R and Vital Capacity).
Detailed description
Patients will be prescribed a fixed dose combination of Ciprofloxacin and Celecoxib to be taken twice daily, and will be monitored for safety and tolerability. Additionally, routine progression measures will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fixed dose Ciprofloxacin and Celecoxib | Experimental | Drug: Fixed dose combination Ciprofloxacin/CelecoxibFixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
- Males or females between the ages of 18 and 75 years of age, inclusive
- Diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria) less than 5 years prior to baseline
- Patients may be on Riluzole and/or Edaravone; 30 days of stable use is required to make safety assessments more reliable
- Upright Forced Vital Capacity (FVC) ≥ 50% of predicted for age, height and sex at screening
Key exclusion criteria (16 listed)
- A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
- Any known clinically significant abnormal gastric mucosal initial gastroscopic of an erosion, ulcer or tumor or/and GI disorder
- Known history of impaired renal function.
- Known or suspected congestive heart and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
- Known history of QT/QTc prolongation, Torsade de pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome) and the use of concomitant medications that prolong the QT/QTc interval.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed dose combination Ciprofloxacin/CelecoxibAlso: PrimeCFixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day | Drug | Fixed dose Ciprofloxacin and Celecoxib |
Primary outcome
Number of participants with one or more treatment-emergent adverse events
Time frame: 15 months
Treatment emergent adverse event is any medical event associated with the drug
Number of patients who discontinued treatment prematurely
Time frame: 15 months
Number of patients whose treatment is stopped prematurely for any reason
Number of patients who discontinued treatment prematurely due to adverse events
Time frame: 15 months
Number of patients whose treatment is stopped prematurely specifically due to adverse events
Number of patients with significant abnormal laboratory values
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Shefner, MD, PhD principal investigator
Barrow Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fixed dose combination Ciprofloxacin/Celecoxib in people with ALS (Amyotrophic Lateral Sclerosis), run by NeuroSense Therapeutics Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with one or more treatment-emergent adverse events (time frame: 15 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.