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CCR5 Antagonist

Maraviroc + Exercise for Stroke Recovery (CAMAROS Trial)

Phase 2

Recruiting

Led By Sean Dukelow, MD PhD FRCPC

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

- some shoulder abduction with gravity eliminated and visible extension in two or more digits

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke

Awards & highlights

CAMAROS Trial Summary

This trial is testing whether a CCR5 antagonist coupled with exercise can improve upper and lower extremity recovery after a stroke.

Who is the study for?

Adults over 18 with hemiparesis from a recent stroke needing inpatient rehab can join. They must have some arm or leg movement, had an ischemic stroke in the brain's anterior part, and be within 6 weeks post-stroke. Participants need support for daily practice and transport. Exclusions include pre-stroke disability, dementia, certain chronic illnesses including hepatitis or cancer, pregnancy, HIV positivity, specific medication use (e.g., anticonvulsants), and severe kidney issues.Check my eligibility

What is being tested?

The CAMAROS trial is testing if Maraviroc (a drug blocking CCR5) combined with exercise helps recovery of arm and leg functions after a stroke compared to placebo. It's randomized: participants are put into groups by chance to receive either Maraviroc or a dummy pill alongside their exercises.See study design

What are the potential side effects?

Maraviroc may cause liver problems, infections due to weakened immune system response, heart issues like irregular heartbeat, digestive disturbances such as stomach pain or diarrhea; allergic reactions; fever; fatigue; coughing; skin rash.

CAMAROS Trial Eligibility Criteria

Inclusion Criteria

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

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I can move my shoulder slightly and extend fingers without gravity.

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I am 18 years old or older.

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I am receiving inpatient rehab for weakness on one side of my body.

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I can move my shoulder slightly without gravity or can visibly move two or more fingers, or I can visibly move my hip.

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I had a stroke affecting the front part of my brain.

Select...

I can move my shoulder slightly without gravity or can visibly move two or more fingers. Or, I can visibly move my hip.

Select...

I can visibly bend and straighten my hip.

CAMAROS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (between 5 days and 6 weeks after stroke) and 6-months post-stroke

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (between 5 days and 6 weeks after stroke) and 6-months post-stroke

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (between 5 days and 6 weeks after stroke) and 6-months post-stroke for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in 10-Meter Walk Test Score

Change in Fugl-Meyer Upper Extremity Assessment Score

Secondary outcome measures

6 Minute Walk Test

Upper arm

Other outcome measures

European Quality of Life Across 5 Domains (EQ-5D)

Fugl-Meyer Lower Extremity Assessment Score

Montreal Cognitive Assessment (MoCA)

+4 more

Side effects data

From 2008 Phase 4 trial • 18 Patients • NCT00666705

Folliculitis

Constipation

Peripheral neurophathy

Somnolence

100%

80%

60%

40%

20%

Study treatment Arm

Maraviroc

Maraviroc + Raltegravir

Raltegravir

CAMAROS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Maraviroc (Celsentri)Experimental Treatment4 Interventions

Maraviroc (Celsentri) will be administered to this group. Participants will be administered a dose of 300mg to be taken twice per day for the duration of the exercise intervention (8 weeks).

Group II: PlaceboPlacebo Group4 Interventions

An over-encapsulated placebo, or "sugar pill" (so it appears identical to the trial drug) will be administered to this group. Participants will be administered the placebo identical to the 300mg maraviroc tablet for the duration of the exercise intervention (8 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Program

2016

Completed Phase 3

~4930

Motor Learning

2001

N/A

~40

Maraviroc

2014

Completed Phase 4

~1770

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Parkwood Hospital, London, OntarioOTHER

6 Previous Clinical Trials

568 Total Patients Enrolled

3 Trials studying Stroke

463 Patients Enrolled for Stroke

Riverview Health Centre FoundationOTHER

5 Previous Clinical Trials

245 Total Patients Enrolled

1 Trials studying Stroke

52 Patients Enrolled for Stroke

Memorial University of NewfoundlandOTHER

68 Previous Clinical Trials

1,831,902 Total Patients Enrolled

1 Trials studying Stroke

52 Patients Enrolled for Stroke

Media Library

Maraviroc (CCR5 Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04789616 — Phase 2

Stroke Research Study Groups: Maraviroc (Celsentri), Placebo

Stroke Clinical Trial 2023: Maraviroc Highlights & Side Effects. Trial Name: NCT04789616 — Phase 2

Maraviroc (CCR5 Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789616 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Maraviroc's standing with the FDA?

"Maraviroc's safety is only supported by Phase 2 trial data, which means that while there is some evidence of its safety, there is none for its efficacy. Thus, we've given it a score of 2."

Answered by AI

What other research studies have included Maraviroc as a treatment?

"Maraviroc was first studied in 2009 at IRCCS Ospedale Pediatrico Bambino Gesu. To date, 18399 trials have been completed while 5 studies are still recruiting patients. These clinical trials tend to be based in Vancouver, Canada."

Answered by AI

How many test subjects are required for this experiment?

"This particular study has completed recruitment for patients. The trial was posted on May 1st, 2022 and updated two days later. However, there are presently 1085 clinical trials actively searching for patients with stroke and 5 trials for Maraviroc that still require participants."

Answered by AI

Are participants still being signed up for this experiment?

"This study is not currently looking for more patients. It was originally posted on May 1st, 2022 and last updated on the second of the same month. There are 1085 other trials related to stroke that are still recruiting patients, as well as 5 studies centred around Maraviroc."

Answered by AI

Is this a groundbreaking new study?

"At this moment in time, there are 5 ongoing clinical trials involving Maraviroc taking place in 27 cities and 12 countries. The first study was completed in 2009 by ViiV Healthcare. A total of 103 patients were used in the Phase 2 drug approval stage trial. In the 11 years since 2009, a grand total of 18399 additional trials have been conducted."

Answered by AI