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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

75

Phase

  • 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

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

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
Intervention / Treatment
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

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

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)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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