ALSPhase 1NCT02525471
A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)
A Phase 1 study testing RNS60 in people with ALS, run by Sabrina Paganoni, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of RNS60 in patients with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60 on several markers of neuro-inflammation, measured by blood biomarkers and positron emission tomography (PET) imaging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ALS
- What is being tested?
- RNS60
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 18 Oct 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Amyotrophic Lateral Sclerosis (ALS) volunteers must be diagnosed as having possible, probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to modified El Escorial criteria.
- Age 18-80, able to provide informed consent, and comply with study procedures.
- Participants must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to screening (riluzole-naïve participants are permitted in the study).
- Women must not be able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control) for the duration of the study and 3 months after study completion.
- Males should practice contraception for the duration of the study and 3 months after completion.
- Ability to safely lie flat for 90 min for Positron Emission Tomography (PET) procedures in the opinion of the study physician.
- High or mixed affinity to bind translocator (TSPO) protein (Ala/Ala or Ala/Thr)
Who cannot join
- Abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine transaminase (ALT) > 3 times the upper limit of the normal.
- Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent, according to PI judgment.
- Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant if they were to participate in the study.
- History of HIV, clinically significant chronic hepatitis, or other active infection.
- Females must not be lactating or pregnant.
Show all 16Show fewer
- Active participation in another ALS clinical trial within 30 days of the Screening Visit
- Exposure to immunomodulatory medications within 30 days of the Screening Visit.
- Any contraindication to undergo MRI studies such as
- History of a cardiac pacemaker or pacemaker wires
- Metallic particles in the body
- Vascular clips in the head
- Prosthetic heart valves
- Claustrophobia
- Radiation exposure that exceeds the site's current guidelines
- Current use of tobacco products including cigarettes, cigars, snuff and chewing tobacco, or nicotine replacement products such as gum or patch
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine the safety and tolerability of RNS60 in patients with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60 on several markers of neuro-inflammation, measured by blood biomarkers and positron emission tomography (PET) imaging.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a fatal, neurodegenerative disease for which there is no cure. A substantial body of evidence implicates the neuroimmune system in ALS pathophysiology. Of relevance to this study, microglia activation in the brain has been found to correlate positively with faster rate of disease progression. In addition, studies of blood cells in people with ALS have shown an increased activation of two of the major inflammatory cell types in the body, monocytes and T cells. Among T cells, regulatory T cells (Tregs) have been recently proposed to play a role in ALS progression.
RNS60 is an electrokinetically altered aqueous fluid. Chemically, RNS60 is composed of saline and oxygen. The electrokinetic processing of RNS60 in Revalesio's patented Revalesio Pump (RP) produces charge-stabilized nanostructures (CSNs) that exhibit electrical fields. RNS60 is available for intravenous administration and inhalation. RNS60 has been extensively tested in preclinical toxicological studies and has shown very little to no side effects. In addition, RNS60 was well tolerated in three phase I human safety studies, one after intravenous administration and two after inhalation.
Preclinical in vitro and in vivo studies in multiple disease models have demonstrated that RNS60 has broad anti-inflammatory effects. These effects include reduction of microglia activation, increase of the Tregs subpopulation of lymphocytes, and neuroprotection in several disease models.
- Conditions
- ALS
- Being tested
- RNS60
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS60Drug
Also called Electrokinetically Processed Fluid, saline and oxygen
RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 23 weeks.
In addition, subjects will be given the option to continue to receive drug for approximately an additional 24 weeks, for a total of approximately 48 weeks on study drug. Study drug will be given by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) during the extension phase.
| Study group | Role | What they receive |
|---|---|---|
| RNS60 | Experimental | Following screening visit to determine eligibility, enrolled subjects will undergo the baseline visit within 6 weeks where the first intravenous (IV) infusion of study medication, RNS60, will be administered. Study medication for inhalation use will be dispensed at this time, and again at weeks 7 and 15. Subjects will continue once a week follow ups to receive RNS60 by IV infusion, continuing inhalation use the remaining 6 days per week, for 23 weeks total. Additionally, eligible subjects will undergo PET imaging at baseline and again between weeks 18 and 23.
In addition, upon nearing completion of the core study, subjects will be given the option to continue to receive drug for approximately an additional 24 weeks, for a total of approximately 48 weeks on study drug, following the optional extension phase schedule of activities. Receives: Drug: RNS60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Measured by the Number of Participants Experiencing Adverse Events
Safety will be assessed by the occurrence of adverse events over the course of 24 weeks of treatment plus the 4 week off-drug follow-up period (total of 28 weeks). Per the protocol, the first treatment was administered at Baseline (Day 0) and the 24th treatment was administered at Week 23 (Day 161), and a safety phone call performed at Week 28 (Day 196).
Measured: 28 weeks
Tolerability to Complete the Entire 24 Week Study on Study Drug
Tolerability will be defined as the ability of subjects to complete the entire 24-week study on study drug. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered at Week 23.
Measured: 24 weeks
Blood Biomarkers of Inflammation.
Selected biomarkers of inflammation were measured at Baseline and Week 23 on a sub-set of subjects. Biomarkers included IL-17 plasma levels and FOXP3 mRNA expression in whole blood, a marker of Treg function. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Measured: 24 Weeks
Change From Baseline in Standardized Uptake Value (SUV) Normalized to Whole Brain Mean (SUVR) at Approximately 60-90 Minutes Post Injection
Glial activation was estimated in a subset of participants by magnetic resonance positron emission tomography (MR-PET) using the [11C]-PBR28 ligand. The subset excludes individuals homozygous for the T/T allele of the Ala147Thr TSPO polymorphism (rs6971) associated with low affinity for [11C]-PBR28. Glial activation was quantified as a mean standardized uptake value (SUV) using PET images acquired 60 to 90 minutes post-injection of approximately 430 MBq [11C]-PBR28. FreeSurfer v6.0 (https://surfer.nmr.mgh.harvard.edu) was employed to circumscribe a region of interest (ROI) defined anatomically as the precentral gyrus and the anterior portion of the paracentral lobule, bilaterally. SUV of the ROI was normalized to the SUV of the whole brain and expressed as a SUV ratio (SUVR) to control for inter-individual variability in the global [11C]-PBR28 PET signal. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (
Measured: 24 Weeks
Clinical Outcome: Change in Pulmonary Function From Baseline to Week 23, Measured by Slow Vital Capacity (SVC)
The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as the Week 23 minus the Baseline of percent of predicted normal.Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Measured: 24 Weeks
Clinical Outcome: Change in Strength From Baseline to Week 23, Measured by Accurate Test of Limb Isometric Strength (ATLIS)
Accurate Test of Limb Isometric Strength (ATLIS) is a non-invasive device that allows measurements of isometric strength in 12 muscle groups of the arms and legs using a standard protocol (elbow and knee flexion and extension, grip, and dorsiflexion). Results are presented as Week 23 minus Baseline of percentages of predicted normal strength based on age, gender, height, and weight using normative data. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Measured: 24 Weeks
Clinical Outcome: Change in Functional Status Between Baseline and Week 23, Measured by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
The ALSFRS-R is a quickly administered (5 minute) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects change from Baseline to Week 23 in speech and swallowing, fine motor skills, large motor skills, and breathing. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startOct 2015
- Primary completion21 Jun 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ALSStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabrina Paganoni, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sabrina Paganoni, M.D., Massachusetts General Hospital
- Investigators
- Sabrina Paganoni, MD, Principal investigator, Massachusetts General HospitalNazem Atassi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525471
- Sponsor's protocol ID
- RNS60-01
- Status last verified
- May 2021
- First submitted
- 12 Aug 2015
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT02525471
- Acronym / sponsor ID
- RNS60-01
- Conditions
- ALS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sabrina Paganoni, M.D.University, hospital or other
- Study start
- Oct 2015
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of RNS60 in patients with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60 on several markers of neuro-inflammation, measured by blood biomarkers and positron emission tomography (PET) imaging.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a fatal, neurodegenerative disease for which there is no cure. A substantial body of evidence implicates the neuroimmune system in ALS pathophysiology. Of relevance to this study, microglia activation in the brain has been found to correlate positively with faster rate of disease progression. In addition, studies of blood cells in people with ALS have shown an increased activation of two of the major inflammatory cell types in the body, monocytes and T cells. Among T cells, regulatory T cells (Tregs) have been recently proposed to play a role in ALS progression.
RNS60 is an electrokinetically altered aqueous fluid. Chemically, RNS60 is composed of saline and oxygen. The electrokinetic processing of RNS60 in Revalesio's patented Revalesio Pump (RP) produces charge-stabilized nanostructures (CSNs) that exhibit electrical fields. RNS60 is available for intravenous administration and inhalation. RNS60 has been extensively tested in preclinical toxicological studies and has shown very little to no side effects. In addition, RNS60 was well tolerated in three phase I human safety studies, one after intravenous administration and two after inhalation.
Preclinical in vitro and in vivo studies in multiple disease models have demonstrated that RNS60 has broad anti-inflammatory effects. These effects include reduction of microglia activation, increase of the Tregs subpopulation of lymphocytes, and neuroprotection in several disease models.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RNS60 | Experimental | Drug: RNS60Following screening visit to determine eligibility, enrolled subjects will undergo the baseline visit within 6 weeks where the first intravenous (IV) infusion of study medication, RNS60, will be administered. Study medication for inhalation use will be dispensed at this time, and again at weeks 7 and 15. Subjects will continue once a week follow ups to receive RNS60 by IV infusion, continuing inhalation use the remaining 6 days per week, for 23 weeks total. Additionally, eligible subjects will undergo PET imaging at baseline and again between weeks 18 and 23. In addition, upon nearing completion of the core study, subjects will be given the option to continue to receive drug for approximately an additional 24 weeks, for a total of approximately 48 weeks on study drug, following the optional extension phase schedule of activities. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Amyotrophic Lateral Sclerosis (ALS) volunteers must be diagnosed as having possible, probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to modified El Escorial criteria.
- Age 18-80, able to provide informed consent, and comply with study procedures.
- Participants must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to screening (riluzole-naïve participants are permitted in the study).
- Women must not be able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control) for the duration of the study and 3 months after study completion.
- Males should practice contraception for the duration of the study and 3 months after completion.
Key exclusion criteria (16 listed)
- Abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine transaminase (ALT) > 3 times the upper limit of the normal.
- Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent, according to PI judgment.
- Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant if they were to participate in the study.
- History of HIV, clinically significant chronic hepatitis, or other active infection.
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 |
|---|---|---|
| RNS60Also: Electrokinetically Processed Fluid, saline and oxygenRNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 23 weeks. In addition, subjects will be given the option to continue to receive drug for approximately an additional 24 weeks, for a total of approximately 48 weeks on study drug. Study drug will be given by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) during the extension phase. | Drug | RNS60 |
Primary outcome
Safety as Measured by the Number of Participants Experiencing Adverse Events
Time frame: 28 weeks
Safety will be assessed by the occurrence of adverse events over the course of 24 weeks of treatment plus the 4 week off-drug follow-up period (total of 28 weeks). Per the protocol, the first treatment was administered at Baseline (Day 0) and the 24th treatment was administered at Week 23 (Day 161), and a safety phone call performed at Week 28 (Day 196).
Tolerability to Complete the Entire 24 Week Study on Study Drug
Time frame: 24 weeks
Tolerability will be defined as the ability of subjects to complete the entire 24-week study on study drug. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered at Week 23.
Blood Biomarkers of Inflammation.
Time frame: 24 Weeks
Selected biomarkers of inflammation were measured at Baseline and Week 23 on a sub-set of subjects. Biomarkers included IL-17 plasma levels and FOXP3 mRNA expression in whole blood, a marker of Treg function. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Change From Baseline in Standardized Uptake Value (SUV) Normalized to Whole Brain Mean (SUVR) at Approximately 60-90 Minutes Post Injection
Time frame: 24 Weeks
Glial activation was estimated in a subset of participants by magnetic resonance positron emission tomography (MR-PET) using the [11C]-PBR28 ligand. The subset excludes individuals homozygous for the T/T allele of the Ala147Thr TSPO polymorphism (rs6971) associated with low affinity for [11C]-PBR28. Glial activation was quantified as a mean standardized uptake value (SUV) using PET images acquired 60 to 90 minutes post-injection of approximately 430 MBq [11C]-PBR28. FreeSurfer v6.0 (https://surfer.nmr.mgh.harvard.edu) was employed to circumscribe a region of interest (ROI) defined anatomically as the precentral gyrus and the anterior portion of the paracentral lobule, bilaterally. SUV of the ROI was normalized to the SUV of the whole brain and expressed as a SUV ratio (SUVR) to control for inter-individual variability in the global [11C]-PBR28 PET signal. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (
Clinical Outcome: Change in Pulmonary Function From Baseline to Week 23, Measured by Slow Vital Capacity (SVC)
Time frame: 24 Weeks
The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as the Week 23 minus the Baseline of percent of predicted normal.Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Clinical Outcome: Change in Strength From Baseline to Week 23, Measured by Accurate Test of Limb Isometric Strength (ATLIS)
Time frame: 24 Weeks
Accurate Test of Limb Isometric Strength (ATLIS) is a non-invasive device that allows measurements of isometric strength in 12 muscle groups of the arms and legs using a standard protocol (elbow and knee flexion and extension, grip, and dorsiflexion). Results are presented as Week 23 minus Baseline of percentages of predicted normal strength based on age, gender, height, and weight using normative data. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Clinical Outcome: Change in Functional Status Between Baseline and Week 23, Measured by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Time frame: 24 Weeks
The ALSFRS-R is a quickly administered (5 minute) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects change from Baseline to Week 23 in speech and swallowing, fine motor skills, large motor skills, and breathing. Per the protocol, the first treatment was administered on Day 0 (Baseline) and the 24th treatment was administered on Day 161 (Week 23).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sabrina Paganoni, MD principal investigator
Massachusetts General Hospital
Nazem Atassi, MD principal investigator
Massachusetts General Hospital
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 RNS60 in people with ALS, run by Sabrina Paganoni, M.D. 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 7 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 28 May 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 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?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety as Measured by the Number of Participants Experiencing Adverse Events (time frame: 28 weeks). The study lists 7 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 28 May 2021.