Amyotrophic Lateral SclerosisPhase 2NCT04165850
Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALS
A Phase 2 study testing Fixed dose combination Ciprofloxacin/Celecoxib in people with Amyotrophic Lateral Sclerosis and ALS, run by NeuroSense Therapeutics Ltd. at 1 site in Israel.
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 and 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
- Amyotrophic Lateral Sclerosis, ALS
- 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
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Nov 2019to 19 Jan 2021
- Phase
- Phase 2
- 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 laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
- Disease duration after first symptom less than 3 years prior to baseline
- Patients may be treated in parallel with Riluzole and/or Edaravone; 30 days of stable use prior to enrollment is required
- Upright forced vital capacity (FVC) ≥ 50% of predicted for age, height, weight and sex at screening
Show all 9Show fewer
- 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 or 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 erosion, ulcer or tumor or/and GI disorder
- Known history of clinically significant impairment of renal function (creatinine ≥ 1.5)
- 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
Show all 17Show fewer
- 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 patient's ability to understand and/or comply with study procedures and provide informed consent
- Patient who is treated with chronic aspirin or NSAIDs, and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
- 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.
About this study
Official title: Open 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 and 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 thrice daily, and will be monitored for safety and tolerability. Additionally, routine disease progression measures will be assessed.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- 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 thrice daily, total dose 909mg/day
| Study group | Role | What they receive |
|---|---|---|
| Fixed dose Ciprofloxacin and Celecoxib | Experimental | Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/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 posted18 Nov 2019
- Study start25 Nov 2019
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroSense Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivian Drory, MD, Principal investigator, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165850
- Sponsor's protocol ID
- NST002
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS
- ClinicalTrials.gov ID
- NCT04165850
- Acronym / sponsor ID
- NST002
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NeuroSense Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 18 Nov 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 and 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 thrice daily, and will be monitored for safety and tolerability. Additionally, routine disease 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 thrice daily, total dose 909mg/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
- Disease duration after first symptom less than 3 years prior to baseline
- Patients may be treated in parallel with Riluzole and/or Edaravone; 30 days of stable use prior to enrollment is required
Key exclusion criteria (17 listed)
- A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
- Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder
- Known history of clinically significant impairment of renal function (creatinine ≥ 1.5)
- 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 thrice daily, total dose 909mg/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 3 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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.
Vivian Drory, MD principal investigator
Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fixed dose combination Ciprofloxacin/Celecoxib in people with Amyotrophic Lateral Sclerosis and ALS, run by NeuroSense Therapeutics Ltd. at 1 site in Israel.
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 9 inclusion and 17 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 3 Mar 2021. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Mar 2021.