ClinicalTrials.gg
Not yet recruitingNCT07765212INDAMSUpdated Aug 14, 2026

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

A Phase 2 interventional study of Indapamide in Multiple Sclerosis, sponsored by Eva M.M. Strijbis. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Primary conditionMultiple Sclerosis, Chronic ProgressiveRegistry: Multiple SclerosisReclassifiedWhy we changed it
Registry
Multiple Sclerosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Sclerosis, Chronic Progressive
Why
  1. The study's title name Multiple Sclerosis, Chronic Progressive, a narrower term within Multiple Sclerosis.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Eva M.M. Strijbis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Indapamide
  • Futility trial
  • Progressive Multiple Sclerosis
  • PMS
  • PPMS
  • SPMS
  • Primary Progressive Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Timed 25 foot walk
  • T25FW
03

In context

Multiple Sclerosis, Chronic Progressive Reclassified

244 studies on the registry are indexed under Multiple Sclerosis, Chronic Progressive; 53 are open to participants now.

This study's planned enrollment of 75 is above the median of 54 across 189 interventional studies indexed under Multiple Sclerosis, Chronic Progressive.

Browse Multiple Sclerosis, Chronic Progressive studies →

Lead sponsor

This is the only study on the registry with Eva M.M. Strijbis as lead sponsor.

Compared within Multiple Sclerosis, Chronic Progressive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Multiple Sclerosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written 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 for women of .

Exclusion criteria

Exclusion Criteria:

  • Individuals with renal insufficiency and an 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 abnormal screening labs
  • Individuals with cardiac arrhythmia
  • Individuals with a prolonged : 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 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
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Indapamide

    Once daily oral 2.5mg indapamide

    Drug: Indapamide

Interventions

  • No study has previously investigated the effect of indapamide in persons with MS.

06

What researchers measure

Primary outcomes

  1. Number of participants with 20% or more worsening in timed 25 foot walk between the Baseline and the 12 Months follow-up study visit.

    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.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 25 phase 2 interventional studies under Multiple Sclerosis, Chronic Progressive, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 14, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2028
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07765212
Lead sponsor
Eva M.M. Strijbis
Responsible party
Eva M.M. Strijbis (Dr. E.M.M. Strijbis, Neurologist, Amsterdam University Medical Center) — Sponsor-investigator
First posted
Aug 14, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Aug 14, 2026

Study contacts

Wouter C Meijer, MD
Contact
w.c.meijer@amsterdamumc.nl
+31 0625716262

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Indapamide

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