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Amyotrophic Lateral SclerosisPhase 2RNS60NCT03456882

The Effect of RNS60 on ALS Biomarkers

A Phase 2 study testing RNS60 in people with Amyotrophic Lateral Sclerosis, run by Mario Negri Institute for Pharmacological Research at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This prompts new treatments of ALS. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
RNS60
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
147 participants
Where
23 sitesin 2 countries
Study dates
30 May 2017to 30 May 2021
Phase
Phase 2
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

  • Age 18 through 80 years inclusive;
  • Geographically accessible to the site and able to come to the site once a week for 24 weeks;
  • Definite, probable, probable laboratory supported ALS diagnosis according to the revised El Escorial criteria; 4) Disease duration 6 to 24 months from symptom onset;
  • 5) Self sufficiency: Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking); 6) Satisfactory respiratory function (FVC ≥80% of predicted); 7) Documented progression of symptoms in the last three months, as measured by the ALSFRS-R scale; 8) Ability to understand and comply with the study requirements and to give written informed consent personally or via a legally authorized representative; 9) Treatment with riluzole 50 mg twice/day for at least 1 month prior to screening visit.
  • Self sufficiency: this term reflect independence in daily living activities. It is an intuitive parameter to indicate preservation of key functional activities, and - not least - it has shown to be a valid and reliable measure

Who cannot join

  • History of HIV, clinically significant chronic hepatitis, antecedent polio infection, or other active infection;
  • Motor neuron disease (MND) other than ALS;
  • Involvement of systems other than motor possibly determining a functional impairment (as measured by the end-points) for the entire duration of the study;
  • Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with impact on survival or functional disability in the next 12 months;
  • Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal;
  • Poor compliance with previous treatments;
Show all 10Show fewer
  • Other experimental treatments in the preceding 3 months;
  • Women who are lactating or able to become pregnant (e.g. who are not post menopausal, surgically sterile, or using inadequate birth control) and men unable to practice contraception for the duration of the treatment and 3 months after its completion;
  • Unwillingness or inability to take riluzole; 10) Poor capability to use an inhalation device;
  • Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of the normal.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

Italy22 sites

  • Azienda Opsedaliera Universitaria Consorziale Policlinico- Università degli studi di Bari

    Bari

  • Spedali civili di Brescia

    Brescia

  • IRCCS Azienda Ospedaliera Universitaria San Martino IST

    Genova

  • Azienda Ospedaliera Universitaria POLICLINICO "G. MARTINO"

    Messina

  • Ospedale San Raffaele

    Miano

  • Centro Clinico NEMO - Fondazione Serena Onlus

    Milan

  • Presidio Ospedaliero Provinciale - Nuovo Ospedale Civile "S. Agostino Estense"

    Modena

  • Azienda Ospedaliera Universitaria della Seconda Univ. Degli Studi di Napoli (AOU-SUN)

    Naples

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara

  • Ospedale San Francesco ASSL Nuoro

    Nuoro

  • Azienda Ospedaliera di Padova-Università degli studi di Padova

    Padova

  • Azienda Ospedaliera Universitaria Policlinico "P Giaccone"

    Palermo

  • Istituto Neurologico Nazionale "C. Mondino"

    Pavia

  • Azienda Ospedaliero-Universitaria Pisana,

    Pisa

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa

  • Centro Clinico Nemo- Policlinico Gemelli

    Roma

  • POLICLINICO UMBERTO I - Università di Roma "La Sapienza"

    Roma

  • IRCCS Casa sollievo della Sofferenza

    San Giovanni Rotondo

  • Azienda Ospedaliera Universitaria Senese (AOUS)

    Siena

  • Azienda Ospedaliera "Santa Maria" di Terni

    Terni

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino.

    Torino

  • Azienda Ospedaliera "Card. G. Panico"

    Tricase

Other trials in Italy

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This prompts new treatments of ALS. RNS60 is an experimental drug with favorable effects in preclinical studies of neuroinflammation and neurodegeneration. Based on significant efficacy demonstrated in preclinical studies and its excellent clinical safety profile, RNS60 is a promising candidate for a drug to treat ALS. Developing a pharmacodynamic marker will be a first and important step for dose finding and exploration of the mechanism of action in human, and pave the way to trials measuring drug efficacy.

The Investigator propose a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase II trial. The study centers will be located in Italy and at Massachusetts General Hospital (MGH) in Boston. A total of 142 ALS patients will be randomly assigned to RNS60 or placebo (administered by intravenous infusion once/week and inhaled via nebulization every morning for 24 weeks). All participants will also take riluzole (50-mg tablet twice/day). Blood samples for biomarker analysis (protein, RNA) will be collected in the screening period, on day 1, week 4,12 and 24. Both safety and potential therapeutic effects of RNS60 will be also assessed.

Read the detailed description

ALS is a rare neurodegenerative disease that affects motor neurons in the spinal cord, brainstem and motor cortex. The only drug showing to improve survival in patients with ALS is riluzole. However, the benefits of riluzole only consist in a three-month delay of death while disability and other outcome measures are virtually unaffected. This highlights the need to test novel approaches with documented activity on markers of disease mechanisms and, at the same time, able to slow the progression of the disease.

The major determinants of motor neuron death in ALS remain to be established. Emerging evidence points to an involvement of the adaptive immune response in disease progression. RNS60 is a novel agent with immunomodulatory properties. Adding to previous reports of anti-inflammatory and neuroprotective activities of RNS601,2,3,4, our group showed a protective effect of RNS60 on motor neurons in both in vitro and in vivo models of familial ALS carrying the SOD1G93A mutation (unpublished data). Therefore, RNS60 presents itself as a promising candidate for the treatment of ALS patients. Its exceptional safety profile, demonstrated both in preclinical toxicology studies and FDA-approved clinical phase I studies upon inhaled and IV administration, supports testing of RNS60 in clinical phase II studies in ALS.

The investigators have identified six candidate pharmacodynamic markers of RNS60 that have previously been associated with ALS: 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

The investigators have measured and reported the effects on T-reg and IL172 in experimental allergic encephalitis. The investigators also have preliminary unpublished data on MCP1 in allergic asthma.

This background provides the sound rationale for a phase II, biomarker-driven, placebo-controlled, randomized clinical trial.

Primary Objective:

  1. To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

Secondary Objectives:

  1. The preliminary efficacy of RNS60 on functional disability, as measured by the ALSFRS-R scale;
  2. The preliminary efficacy of RNS60 in prolonging survival (or time to tracheostomy, whichever comes first);
  3. The preliminary efficacy of RNS60 in slowing the decline of forced vital capacity (FVC) from baseline;
  4. The tolerability and safety of RNS60 through the identification of unexpected adverse events;
  5. The impact of RNS60 on quality of life as measured by ALSAQ-40 scale.

RNS60 has been tested in three Phase I safety studies in the USA (NCT01264783, NCT01057498, and NCT01511302), and a recently completed Phase IIa (NCT02422121) study in UK. Two additional investigator initiated Phase IIa trials are currently ongoing, one at Mass General Hospital (NCT02525471), and one at the University of Zurich (with University of Innsbruck as a second site). The choice of measuring both biological and clinical markers of disease in the same study reflects the attempt to accurately capture the complete clinical impact of RNS60 treatment. If both the biomarker results and clinical measures of the study support the purported efficacy of the drug, a follow-up study (or studies) will be designed to confirm the efficacy of RNS60 in a larger patient population. It is also possible that this study may result in promising biomarker findings but null clinical findings. If this were the case, more dose-finding work would be necessary before ruling out a possible clinical effect. Conversely, positive clinical findings accompanied by negative biomarker findings may necessitate the identification of new biomarkers of target engagement to further guide the drug development process.

Being tested
RNS60
Keywords
AMYOTROPHIC LATERAL SCLEROSIS, RNS60, Biomarkers, clinical trial, therapy
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.

  • RNS60Drug

    normal saline plus oxigen in nanobubble

Study groups in NCT03456882
Study groupRoleWhat they receive
RNS60Active comparatorRNS60 for injection, i.e. in the IV bags, is produced using 0.9% Sodium Chloride for injection. RNS60 for inhalation, i.e. in the syringes, is produced using 0.9% Sodium Chloride for irrigation. Syringes and IV bags are to remain refrigerated at 2 to 8°C (36 to 46°F) when not in use. RNS60 meets its stability specification for 12 months.
Receives: Drug: RNS60
NORMAL SALINEPlacebo comparatorNormal saline (NS) for injection, i.e. in the IV bags, is packaged 0.9% Sodium Chloride for injection. NS for inhalation, i.e. in the syringes, is packaged 0.9% Sodium Chloride for irrigation. NS does not require refrigerated storage for use. However, for blinding purposes refrigeration is required before distributing to subjects. NS meets stability specifications for 24 months. RNS60 has been tested in three Phase I safety studies, NCT01264783, NCT01057498, and NCT01511302 in the USA, and a Phase IIa (NCT02422121) study in UK without any safety concern. Two other Investigator initiated Phase IIa trials are currently ongoing, one in Mass General Hospital (NCT02525471), and one in the University of Zurich (with University of Innsbruck as a second site).
Receives: Drug: RNS60

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacodynamic Biomarkers: MCP-1 On-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

  2. Pharmacodynamic Biomarkers: Cyp-A On-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

  3. Pharmacodynamic Biomarkers: Actin-NT On-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

  4. Pharmacodynamic Biomarkers: 3-NT On-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

  5. Pharmacodynamic Biomarkers: IL-17 On-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

  6. Pharmacodynamic Biomarkers: Nfl On-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

  7. Pharmacodynamic Biomarkers: FOXP3 mRNA On-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

  8. Pharmacodynamic Biomarkers: CD25 mRNA On-treatment Period Variation

    1. To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 0 - week 24)

Secondary outcomes (13)

  1. ALSFRS-R On-treatment and Off-treatment Variation

    ALSFRS-R = ALS Functional Rating Scale - Revised The mean change of ALSFRS-R (min score 0 corresponding to maximum functional impairment - max score 48 corresponding to no functional impairment; higher score = better outcome) over the on-treatment period and the off-treatment follow-up period. Measured at weeks 0, 4, 12, 24, 36, 48.

    Measured: 24 weeks on-treatment period (week 0 - week 24) + 24 weeks off-treatment follow-up period (week 24 - week 48)

  2. Survival

    The cumulative survival probability at 4, 12, 24, 36 and 48 weeks in the two treatment arms.

    Measured: 24 weeks on-treatment period (week 0 - week 24) + 24 weeks off-treatment follow-up period (week 24 - week 48)

  3. FVC% On-treatment and Off-treatment Variation

    The mean change of Forced Vital Capacity percent value (FVC%) over the on-treatment period and the off-treatment follow-up period. Measured at weeks 0, 4, 12, 24, 36, 48.

    Measured: 24 weeks on-treatment period (week 0 - week 24) + 24 weeks off-treatment follow-up period (week 24 - week 48)

  4. AE Leading to Treatment Discontinuation

    The total number of subjects in the two treatment arms experiencing at least one adverse event (AE) leading to treatment discontinuation at 4, 12 and 24 weeks

    Measured: 24 weeks on-treatment period

  5. ALSAQ-40 Scale

    ALSAQ-40=ALS Assessment Questionnaire - 40 items The mean change of ALSAQ-40 over the on-treatment period and the off-treatment follow-up period. Measured at weeks 0, 24, 48. The ALSAQ-40 is a 40-item questionnaire measuring health status and health related quality of life in ALS patients. It is divided in 5 domains: the physical mobility (it addresses problems of mobility); the ADL (activities of daily living) and independence (it addresses a variety of limitations in ADL); the eating and drinking (it adresses problems eating solid foods, swallowing and drinking liquids); the communication (it addresses a variety of problems in communicating with others); the emotional reactions (it addresses various emotional problems).

    **

    For each domain the score has the following range:

    Min score =0 corresponding to the better condition - max score =100 corresponding to the worse condition. (A higher score corresponds to a better outcome )

    **

    Measured: 24 weeks on-treatment period (week 0 - week 24) + 24 weeks off-treatment follow-up period (week 24 - week 48)

  6. Pharmacodynamic Biomarkers: MCP-1 Off-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 24 - week 48)

  7. Pharmacodynamic Biomarkers: Cyp-A Off-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 24 - week 48)

  8. Pharmacodynamic Biomarkers: Actin-NT Off-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 24 - week 48)

  9. Pharmacodynamic Biomarkers: 3-NT Off-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 24 - week 48)

  10. Pharmacodynamic Biomarkers: IL-17 Off-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 24 - week 48)

  11. Pharmacodynamic Biomarkers: FOXP3 mRNA Off-treatment Period Variation

    To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 24 - week 48)

  12. Pharmacodynamic Biomarkers: CD25 mRNA Off-treatment Period Variation

    1. To measure the effect of RNS60 treatment on selected pharmacodynamic biomarkers in ALS patients concurrently treated with riluzole. Candidate markers include 1. T-reg (measured via FOXP3 and CD25 mRNA); 2. Cyp-A; 3. 3-NT; 4. Actin-NT; 5. MCP-1; 6. IL-17.

    Measured: 24 weeks (week 24 - week 48)

  13. Mean Number of AE

    The mean number of AEs per treatment arm at 4, 12, 24 and 48 weeks

    Measured: 24 weeks on-treatment period (week 0 - week 24) + 24 weeks off-treatment follow-up period (week 24 - week 48)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start30 May 2017
  3. Primary completion23 Nov 2020
  4. Study completion30 May 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, double-blind, placebo-controlled, parallel group, add-on phase II trial. ALS Patients who meet the study's inclusion/exclusion criteria and sign the Informed Consent Form will be enrolled. A total of 142 subjects will be randomly assigned to receive treatment with either RNS60 or placebo while concomitantly taking riluzole (50 mg tablet t.i.d.). RNS60 or placebo will be administered intravenously once a week as well as inhaled via nebulization every morning in the remaining six days of each week for 24 weeks. Blood samples for biomarker analysis will be collected on day 1, week 4, w12, and w24. Safety and preliminary efficacy will be assessed by way of physical exam, vital signs and AEs. Changes in disability and quality of life will be assessed using the ALSFRS-R scale, FVC and ALSAQ-40 scale. Each patient will be followed up for a maximum period of 48 weeks (24-week treatment + 24-week follow up) or until death or tracheostomy, whichever occurs first.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456882
Sponsor's protocol ID
RNS60
Acronym
RNS60
Status last verified
Mar 2023
First submitted
2 Feb 2018
Last updated
21 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pupillo E, Bianchi E, Bonetto V, Pasetto L, Bendotti C, Paganoni S, Mandrioli J, Mazzini L; RNS60-ALS Study Group. Long-term survival of participants in a phase II randomized trial of RNS60 in amyotrophic lateral sclerosis. Brain Behav Immun. 2024 Nov;122:456-462. doi: 10.1016/j.bbi.2024.08.044. Epub 2024 Aug 28.

    PubMed 39182589

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RNS60 in people with Amyotrophic Lateral Sclerosis, run by Mario Negri Institute for Pharmacological Research at 23 sites in 2 countries.

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 5 inclusion and 10 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Italy, 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 21 Apr 2023). 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?

Pharmacodynamic Biomarkers: MCP-1 On-treatment Period Variation (time frame: 24 weeks (week 0 - week 24)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03456882, which also lists 1 linked publication.

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 21 Apr 2023.

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