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

Not Yet RecruitingPhase 2

Sponsor: Eva M.M. Strijbis

Conditions: Multiple Sclerosis

Interventions: Indapamide

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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