What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) with immunomodulatory effects include interferon beta, glatiramer acetate, fingolimod, and dimethyl fumarate. Interferon beta can cause flu-like symptoms, injection site reactions, and elevated liver enzymes. Glatiramer acetate may lead to injection site reactions and, rarely, lipoatrophy. Fingolimod is associated with headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased risk of infections. Dimethyl fumarate commonly causes flushing, gastrointestinal issues, and may also elevate liver enzymes. These treatments aim to modulate the immune response to reduce MS activity.

What prior FDA approvals exist?

Several FDA-approved treatments for Multiple Sclerosis (MS) focus on anti-inflammatory and immunomodulatory effects. Interferon beta-1a and beta-1b are commonly used and have shown efficacy in reducing relapse rates and MRI lesion volumes. Glatiramer acetate, another immunomodulatory drug, is also approved and works by modifying immune processes. Dimethyl fumarate (BG-12) has anti-inflammatory properties and has been effective in reducing relapse rates and disability progression. While diuretics like Indapamide are not typically used in MS treatment, the focus remains on immunomodulation and inflammation control.

What other types of research exist?

Promising novel alternatives for Multiple Sclerosis treatment in 2024 include: 1) Laquinimod, a synthetic immunomodulatory compound that has shown modest efficacy in reducing relapse rates and disability progression in MS patients. 2) Lenvatinib plus Pembrolizumab, which has demonstrated improved progression-free survival and overall response rates in clinical trials. 3) Interferon beta-1a, available in various formulations, has been effective in reducing relapse rates and MRI lesion volumes. These alternatives offer immunomodulatory and anti-inflammatory benefits, potentially providing superior outcomes for MS patients.

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Antimalarial Drug

Hydroxychloroquine + Indapamide for Secondary Progressive Multiple Sclerosis

Phase 2

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Screening timed 25-foot walk (average of two trials) of 9 seconds or more

Men and women aged 18 and 60 years inclusive

Must not have

Individuals with cardiac arrhythmia

Individuals with retinopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial tests if two medications, Hydroxychloroquine (HCQ) and Indapamide (IND), can help people with secondary progressive multiple sclerosis (SPMS). HCQ calms down certain brain cells that can harm nerves, while IND protects nerve cells from damage. The goal is to see if these drugs can slow down the worsening of disability in SPMS patients.

Who is the study for?

This trial is for adults aged 18-60 with secondary progressive multiple sclerosis (SPMS), who can walk at least 25 feet in 9 seconds or more, and have a certain level of disability. People with eye, kidney, liver problems, heart issues like arrhythmia or prolonged QT interval, those on specific medications like Fampridine or using Botulinum toxin in leg muscles during the trial are excluded.

What is being tested?

The study tests if Hydroxychloroquine (400mg daily) and Indapamide (2.5mg daily) can slow down SPMS disability progression. It involves up to 42 participants and does not have pharmaceutical industry sponsorship; it's funded by the University of Calgary.

What are the potential side effects?

Potential side effects may include vision changes due to retinopathy risk, possible kidney or liver function impairment, heart-related issues such as arrhythmias or prolonged QT interval which could be serious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It takes me 9 seconds or more to walk 25 feet.

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I am between 18 and 60 years old.

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My condition is diagnosed as Secondary Progressive Multiple Sclerosis.

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My disability level is moderate to severe but I can still walk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an irregular heartbeat.

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I have a condition affecting my retina.

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I will receive Botulinum toxin treatment in my leg muscles during the trial.

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I have severe liver problems.

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I will start taking Baclofen or Tizanidine during the trial.

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I will start taking Fampridine or 4-aminopyridine during the trial.

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I will not change my Baclofen or Tizanidine dose during the trial.

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I am currently taking siponimod, amiodarone, dapsone, digoxin, or antimalarial drugs.

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I have or might develop kidney problems during the trial.

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I am currently using Fampridine or 4-aminopyridine.

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My heart's electrical cycle length is within the safe range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Timed 25-Foot Walk (T25FW)

Secondary study objectives

9-Hole Peg Test

Functional Systems and Expanded Disability Status Scale (EDSS)

Modified Fatigue Impact Scale (MFIS)

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hydroxychloroquine and IndapamideExperimental Treatment2 Interventions

Oral Hydroxychloroquine, 200mg BID Oral Indapamide, 2.5 mg OD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydroxychloroquine

FDA approved

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) often target the immune system to reduce inflammation and prevent neurodegeneration. Disease-modifying therapies (DMTs) like interferon beta and glatiramer acetate work by modulating the immune response to decrease the frequency and severity of relapses. Anti-inflammatory and immunomodulatory agents, such as those being studied in the trial with hydroxychloroquine (HCQ), aim to reduce the underlying inflammation that contributes to MS progression. Diuretics and vasodilators, like Indapamide, may help manage symptoms by improving blood flow and reducing fluid retention, which can alleviate some neurological symptoms. These mechanisms are crucial for MS patients as they help slow disease progression, reduce disability, and improve quality of life.

Construction of miRNA-regulated drug-pathway network to screen drug repurposing candidates for multiple sclerosis.Mode of action and clinical studies with alemtuzumab.Disease-modifying treatments for progressive multiple sclerosis.