Multiple Sclerosis Relapsing RemittingPhase 2IN-DXM-EMRRNCT06223074
Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration
A Phase 2 study testing IV Methylprednisolone administration and Nasal Methylprednisolone (MT) in people with Multiple Sclerosis Relapsing Remitting and Treatment, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis Relapsing Remitting, Treatment
- What is being tested?
- IV Methylprednisolone administration and Nasal Methylprednisolone (MT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 9 Jan 2023to 5 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Diagnosis of RRMS with an evolution from diagnosis of 3 months to 10 years.
- Kurtzke Expanded Disability Status Scale (EDSS) from 1 to 6 (grade 6 includes patients with unilateral aid to ambulate)
- No contraindication for the administration of MP.
- Agree to participate in the study by means of a signed informed consent
Who cannot join
- Intake of anti-inflammatory steroids in the last 3 days.
- Patients with active bacterial, viral or fungal infections or undergoing treatment.
- Patients with hypertension.
- Patients with diabetes mellitus.
- Patients with hypo or hyperthyroidism.
- Patients with glaucoma.
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- Patients with neoplasms.
- Diagnosis of systemic diseases such as: cardiovascular, pulmonary, hepatic, endocrine, gastrointestinal, etc.
- Patients with suspected or confirmed pregnancy by means of serum or urinary laboratory tests.
- Breastfeeding patients.
- Patients with a history of resistance to glucocorticoids.
- Patients with a history of severe adverse reactions to glucocorticoids.
- Patients with a history of hyposmia or anosmia.
- Patients diagnosed with active sinusitis.
- Patients with allergic rhinitis.
- Patients with upper respiratory tract infections.
- deviated septum
- History of nasal surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Nacional de Neurología y Neurocirugía
Mexico City, 14269
About this study
Official title: Towards the Improvement of the Treatment of Acute Relapses in Multiple Sclerosis: A Randomized Double-blind, Non-inferiority Controlled Trial Comparing Intranasal Versus Intravenous Methylprednisolone
This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis
Read the detailed description
This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat.
- Conditions
- Multiple Sclerosis Relapsing Remitting, Treatment
- Being tested
- IV Methylprednisolone administration, Nasal Methylprednisolone (MT)
- Keywords
- methylprednisolone, intranasal administration, Multiple Sclerosis Relapsing Remitting
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Methylprednisolone administrationOther
Also called ST
Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse
Nasal Methylprednisolone (MT)Drug
Also called Nasal MT
Group 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse
| Study group | Role | What they receive |
|---|---|---|
| Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis | Active comparator | Intravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse. Thus, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intravenous methylprednisolone, 1000 mg, once a day for 3 days for moderate relapses or 5 days for severe ones.
A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent. Receives: Other: IV Methylprednisolone administration |
| Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis | Experimental | Nasal Methylprednisolone Administration For this group, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intranasal methylprednisolone administration (1000 mg once a day for 3 days for moderate relapses or 5 days for severe ones) using a Mucosal Atomization Device (MAD Nasal).
A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent Receives: Drug: Nasal Methylprednisolone (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments
- The Expanded Disability Status Scale has a minimum score of 0, when the patient has no MS-related disability or abnormalities, and a maximum score of 10, when death is caused by MS.
- Patients will be assessed with the EDSS prior to treatment and 30 days after the treatment ends
Measured: Days 0 and 30 after treatment
Secondary outcomes (1)
Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment
Enzyme-Linked Immunosorbent Assay (ELISA) to detect inflammatory molecules will be performed in plasma derived from blood samples taken from patients prior to treatment, on day 5 of treatment and 30 days after treatment
Measured: Days 0, 5 and 30 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start9 Jan 2023
- Primary completion25 Feb 2026 (estimated)
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis Relapsing RemittingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, comparative, randomized, controlled study in adult patients with confirmed Relapsing-Remitting Multiple Sclerosis that assits to the hospital with an acute relapse.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Neurología y Neurocirugía
- Responsible party
- Principal investigator, Edda Sciutto Conde, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223074
- Sponsor's protocol ID
- BD2012-34CEC
- Acronym
- IN-DXM-EMRR
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information exchange for research purposes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards the Improvement of the Treatment of Acute Relapses in Multiple Sclerosis: A Randomized Double-blind, Non-inferiority Controlled Trial Comparing Intranasal Versus Intravenous Methylprednisolone
- ClinicalTrials.gov ID
- NCT06223074
- Acronym / sponsor ID
- IN-DXM-EMRR / BD2012-34CEC
- Conditions
- Multiple Sclerosis Relapsing Remitting, Treatment
- Keywords
- methylprednisolone, intranasal administration, Multiple Sclerosis Relapsing Remitting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- Instituto Nacional de Neurología y Neurocirugía
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 25 Jan 2024 (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 Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis
Detailed description
This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A prospective, comparative, randomized, controlled study in adult patients with confirmed Relapsing-Remitting Multiple Sclerosis that assits to the hospital with an acute relapse.
| Arm | Type | Receives |
|---|---|---|
| Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis | Active comparator | Other: IV Methylprednisolone administrationIntravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse. Thus, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intravenous methylprednisolone, 1000 mg, once a day for 3 days for moderate relapses or 5 days for severe ones. A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent. |
| Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis | Experimental | Drug: Nasal Methylprednisolone (MT)Nasal Methylprednisolone Administration For this group, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intranasal methylprednisolone administration (1000 mg once a day for 3 days for moderate relapses or 5 days for severe ones) using a Mucosal Atomization Device (MAD Nasal). A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Diagnosis of RRMS with an evolution from diagnosis of 3 months to 10 years.
- Kurtzke Expanded Disability Status Scale (EDSS) from 1 to 6 (grade 6 includes patients with unilateral aid to ambulate)
- No contraindication for the administration of MP.
- Agree to participate in the study by means of a signed informed consent
Key exclusion criteria (18 listed)
- Intake of anti-inflammatory steroids in the last 3 days.
- Patients with active bacterial, viral or fungal infections or undergoing treatment.
- Patients with hypertension.
- Patients with diabetes mellitus.
- Patients with hypo or hyperthyroidism.
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 |
|---|---|---|
| IV Methylprednisolone administrationAlso: STGroup 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse | Other | Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis |
| Nasal Methylprednisolone (MT)Also: Nasal MTGroup 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse | Drug | Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis |
Primary outcome
Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments
Time frame: Days 0 and 30 after treatment
* The Expanded Disability Status Scale has a minimum score of 0, when the patient has no MS-related disability or abnormalities, and a maximum score of 10, when death is caused by MS. * Patients will be assessed with the EDSS prior to treatment and 30 days after the treatment ends
1 secondary outcome
Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment
Time frame: Days 0, 5 and 30 after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. Information exchange for research purposes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IV Methylprednisolone administration and Nasal Methylprednisolone (MT) in people with Multiple Sclerosis Relapsing Remitting and Treatment, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 18 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: enrolling by invitation, as of the sponsor's last update on 3 Apr 2025. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments (time frame: Days 0 and 30 after treatment). 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 Apr 2025.