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Antimalarial Drug
Hydroxychloroquine + Indapamide for Secondary Progressive Multiple Sclerosis
Phase 2
Recruiting
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
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
Study Summary
This trial is to test if a combination of two drugs can help reduce disability in people with secondary progressive multiple sclerosis.
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.Check my eligibility
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.See study design
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 belowSelect...
It takes me 9 seconds or more to walk 25 feet.
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I am between 18 and 60 years old.
Select...
My condition is diagnosed as Secondary Progressive Multiple Sclerosis.
Select...
My disability level is moderate to severe but I can still walk.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Timed 25-Foot Walk (T25FW)
Secondary outcome measures
9-Hole Peg Test
Functional Systems and Expanded Disability Status Scale (EDSS)
Modified Fatigue Impact Scale (MFIS)
+2 moreTrial 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
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,119 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
381 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an irregular heartbeat.I have a condition affecting my retina.You have a condition in your eyes called retinopathy.You have porphyria.People with unusual test results during the initial check-up.You are allergic or can't tolerate hydroxychloroquine or indomethacin.I will receive Botulinum toxin treatment in my leg muscles during the trial.I have severe liver problems.I will start taking Baclofen or Tizanidine during the trial.I will start taking Fampridine or 4-aminopyridine during the trial.I will not change my Baclofen or Tizanidine dose during the trial.I am currently taking siponimod, amiodarone, dapsone, digoxin, or antimalarial drugs.It takes me 9 seconds or more to walk 25 feet.I am between 18 and 60 years old.My condition is diagnosed as Secondary Progressive Multiple Sclerosis.I have or might develop kidney problems during the trial.I am currently using Fampridine or 4-aminopyridine.My disability level is moderate to severe but I can still walk.My heart's electrical cycle length is within the safe range.
Awards:
This trial has 3 awards, including:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Hydroxychloroquine and Indapamide
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include young people in their twenties?
"The minimum age that a patient can be to enroll in this study is 18 and the maximum age is 60."
Answered by AI
Are there any patients who have not yet been enrolled in this research?
"The website clinicaltrials.gov provides evidence that this study is still looking for patients to enroll. This research was first posted on October 1st, 2021 and the most recent update was on May 16th, 2022. They are recruiting from just 1 site but need a total of 35 individuals."
Answered by AI
How many individuals are included in this research project?
"That is correct, the trial is still actively recruiting patients. The listing on clinicaltrials.gov shows that the study was posted on October 1st 2021 and updated most recently on May 16th 2022. They are hoping to enroll 35 patients from a single site."
Answered by AI
If I meet the requirements, may I join this clinical trial?
"Those suffering from multiple sclerosis and between the ages of 18-60 may be eligible for this trial. So far, 35 patients have been enrolled."
Answered by AI
Has the Hydroxychloroquine Pill undergone FDA approval?
"While Phase 2 trials have not yet provided data to support efficacy, there is enough information indicating Hydroxychloroquine Pill's safety to merit a score of 2."
Answered by AI
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