Evaluating the Use of Oral Indapamide to Reduce Disabiltiy Progression in Progressive Multiple Sclerosis (MS) (INDAMS)

August 10, 2026 updated by: Eva M.M. Strijbis

Open-Label, Single-Center, Single-Arm Phase 2 Futility Trial Evaluating the Use of Oral Indapamide for Reducing Pprogression of Disability in People With Primary and Secondary Progressive Multiple Sclerosis (MS)

The goal of this clinical trial is to determine whether treatment with indapamide can slow the rate of progression in patients with progressive forms of multiple sclerosis (MS). The main question it aims to answer is whether this treatment can reduce the speed at which the walking speed of patients with progressive MS (PMS) worsens. Participants will take an indapamide tablet once daily for 12 months. During this time, among others, their walking speed will be assessed several times.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Finding an effective treatment for progressive multiple sclerosis (PMS) is one of the greatest challenges and unmet needs in MS research. Despite the many anti-inflammatory therapies currently available, about 2-3 percent of people with relapsing-remitting MS (RRMS) convert to secondary progressive MS (SPMS) per year. Around 10 to 15 percent of people with MS suffer from primary progressive MS (PPMS). In both forms of PMS, disability worsening occurs steadily, unrelentingly, and independent of relapses.

Comparative pathological studies show that PMS differs from RRMS in several important aspects: active demyelinating lesions are frequent in RRMS but infrequent in PMS, while neurodegeneration, cortical lesions, and slowly expanding white matter lesions all are more prominent in PMS compared to RRMS. Underlying this, in PMS there is more oxidative tissue injury, mitochondrial dysfunction, and diffuse neurodegeneration. Oxidative tissue injury is a key pathophysiological factor implicated in PMS, and other chronically progressive neurological diseases. Reactive oxygen and nitrogen species are elevated, and cause oxidative damage to organelles such as mitochondria in MS. In-vitro experiments have found that the generic antihypertensive drug indapamide (IND) has a very powerful antioxidant, as well as neuroprotective effect in in-vitro experiments. We hypothesize that treating people with PMS with IND can reduce the worsening of disability in PMS.

This study is a phase 2 futility trial with a single intervention arm using a Simon Two-Stage futility design. We will include up to 42 participants with PPMS and up to 42 participants with SPMS who will be followed for 12 months.

We will include people with PPMS and SPMS aged 18 to 65 years, with a screening EDSS score of 4.0 to 6.5 inclusive. We will include participants with a screening T25FW of 5 seconds or more if they have PPMS, and with 9 seconds or more if they have SPMS, based on slightly different progression speeds. Exclusion criteria are known contra-indications to indapamide, pregnancy and breast-feeding in women, and specific co-medications.

The primary outcome will be disability worsening, defined as a >=20% worsening on the timed 25 foot walk (T25FW) at month 12 compared to the baseline measurement (without confirmation). The primary outcome measure will be assessed at screening, at baseline, and at 1, 6, and 12 months of follow-up. Secondary outcome measures include the Expanded Disability Status Scale, Symbol Digit Modalities Test, and patient reported outcomes of fatiguiability and quality of life.

Trial participants will be treated with 2.5mg IND once daily day for 12 months, with study visits at baseline, 2 weeks, 1 month, and 3, 6, 9, and 12 months. An interim futility analysis will determine whether the trial will continue or stop prematurely. Once 13 patients with PPMS and 13 patients with SPMS have completed the full 12 month follow up with sufficient adherence to medication. If 5 out of the 13 in each group have experienced a significant worsening of the T25FW indapamide treatment in PMS will be deemed futile, and the trial will be stopped, as the rate of progression is then sufficiently similar to historical data of untreated PMS patients.

During the trial safetly labs will be drawn and ECGs will be made to ensure the safety of the trial participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent obtained
  • Aged between 18 and 65 years
  • Diagnosed with PPMS or SPMS, according to current diagnostic criteria
  • Screening Expanded Disability Status Scale score between 4.0 and 6.5 inclusive.
  • Screening T25FW (average of two trials) of 5 seconds or more for people with PPMS, or of 9 seconds or more for people with SPMS
  • Use of effective methods of contraception for women of childbearing potential.

Exclusion Criteria:

  • Individuals with renal insufficiency and an eGFR below 30ml/min per 1.73 m2
  • Individuals with a blood pressure below 110 mmHg systolic or 70 mmHg diastolic
  • Individuals with significant hepatic impairment (pre-existing or developing during the trial)
  • Individuals with clinically significant abnormal screening labs
  • Individuals with cardiac arrhythmia
  • Individuals with a prolonged QT interval: individuals with frequency corrected QT (QTc) intervals of more than 450ms (men) or 470ms (women) at the screening examination will not be included in the study, and participants with QTc intervals of greater than 500ms on any of the other ECG examinations throughout the study will be excluded from the study.
  • Individuals who are pregnant or currently breast-feeding
  • Individuals with an allergy or other intolerability to IND
  • Individuals who use Fampridine or 4-aminopyridine
  • Individuals who start Fampridine or 4-aminopyridine during the trial
  • Individuals who start Baclofen or Tizanidine during the trial
  • Individuals who increase the dose of Baclofen or Tizanidine during the trial
  • Individuals who receive treatment with Botulinum toxin in the leg muscles during the trial
  • Individuals who use siponimod, ocrelizumab, natalizumab or other disease-modifying treatment for RRMS
  • Individuals with recent gadolinium enhancement or new T2 lesions on brain/spinal cord MRI in the 6 months prior to inclusion
  • Concomitant use of corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Indapamide
Once daily oral 2.5mg indapamide
Drug: Indapamide
No study has previously investigated the effect of indapamide in persons with MS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with 20% or more worsening in timed 25 foot walk between the Baseline and the 12 Months follow-up study visit.
Time Frame: 12 months
The T25FW is the time it takes for the participant to walk 25 feet, averaged over two trials. Significant worsening is defined as a more than or equal to 20 percent increase in the T25FW.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eva M.M. Strijbis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-525260-18-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pseudonymized participant data will only be shared if a sufficiently qualified researcher requests the data with a valid reason, if the participant has separately given permission for this in their informed consent form, and if the receiving country has adequate data protection (adequacy decision according to article 45 of the GDPR). It is voluntary for patients to give consent for data transfer outside of the EU.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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