120 Participants Needed

Maraviroc + Exercise for Stroke Recovery

(CAMAROS Trial)

Recruiting at 8 trial locations
CD
AM
MP
MP
AM
Overseen ByAlexandra McKinnon
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing whether the drug Maraviroc, combined with exercise, can help stroke patients recover better. It targets patients shortly after their stroke because recovery often slows down after a few months. Maraviroc might help the brain and nerves heal more effectively when paired with exercise.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, if you are currently taking anticonvulsants like Carbamazepine, Phenobarbital, or Phenytoin, or certain antifungal and antibacterial medications like Ketoconazole or Clarithromycin, you will need to stop. Also, if you are taking St. John's Wort or Paxlovid, you will need to discontinue those as well.

What data supports the effectiveness of the treatment Maraviroc + Exercise for Stroke Recovery?

Exercise and physical therapy have been shown to be beneficial for stroke recovery, as they can improve motor function and overall rehabilitation. Additionally, the use of selective serotonin reuptake inhibitors (a type of antidepressant) has been associated with improved motor recovery, suggesting that pharmacological interventions can aid in stroke rehabilitation.12345

How is the drug Maraviroc combined with exercise unique for stroke recovery?

Maraviroc, typically used for HIV treatment, is being explored for stroke recovery due to its potential to reduce inflammation and improve brain repair, which is different from standard stroke treatments that focus on blood flow restoration and physical rehabilitation.678910

Research Team

BD

Bruce Dobkin, MD

Principal Investigator

University of California, Los Angeles, California, USA

SD

Sean Dukelow, MD PhD FRCPC

Principal Investigator

University of Calgary, Calgary, Alberta, Canada

Eligibility Criteria

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.

Inclusion Criteria

I can move my shoulder slightly and extend fingers without gravity.
I am 18 years old or older.
I am receiving inpatient rehab for weakness on one side of my body.
See 9 more

Exclusion Criteria

Pregnant, breastfeeding, or positive test for pregnancy at baseline
You have been diagnosed with HIV.
My kidney function is reduced with a creatinine clearance rate below 60 mL/min.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline physical and cognitive assessments, including the use of wrist and ankle activity sensors

1 week
1 visit (in-person)

Treatment

Participants receive either Maraviroc or placebo alongside an 8-week daily exercise program

8 weeks
4 visits (in-person) for assessments at 4 and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 months post-stroke

4 months
1 visit (in-person)

Treatment Details

Interventions

  • Activity Sensor
  • Exercise Program
  • Maraviroc
  • Motor Learning
  • Placebo
Trial OverviewThe 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.
Participant Groups
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).

Maraviroc is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Selzentry for:
  • HIV-1 infection in combination with other antiretroviral agents
🇪🇺
Approved in European Union as Celsentri for:
  • HIV-1 infection in combination with other antiretroviral agents
🇨🇦
Approved in Canada as Selzentry for:
  • HIV-1 infection in combination with other antiretroviral agents

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Parkwood Hospital, London, Ontario

Collaborator

Trials
8
Recruited
790+

Riverview Health Centre Foundation

Collaborator

Trials
6
Recruited
340+

Memorial University of Newfoundland

Collaborator

Trials
73
Recruited
1,836,000+

Dalhousie University

Collaborator

Trials
177
Recruited
402,000+

The Dr. Miriam and Sheldon G. Adelson Medical Research Foundation

Collaborator

Trials
1
Recruited
120+

University Health Network, Toronto

Collaborator

Trials
1,555
Recruited
526,000+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials
693
Recruited
1,569,000+

University of British Columbia

Collaborator

Trials
1,506
Recruited
2,528,000+

Findings from Research

Only one small randomized controlled trial met the criteria for evaluating vinpocetine's effects on stroke, and it found no significant differences in mortality or dependency between the treatment and placebo groups.
No adverse effects were reported in the study, but the limited evidence means we cannot conclusively determine vinpocetine's efficacy in reducing case fatality or dependency after an acute stroke.
A systematic review of vinpocetine therapy in acute ischaemic stroke.Bereczki, D., Fekete, I.[2019]
In a study of 95 patients with acute carotid ischemic stroke, those who received cereton in addition to traditional treatment showed a significant reduction in neurological deficits and improved functional independence compared to those who only received traditional treatment.
The cost-effectiveness analysis indicated that cereton was more effective, as it achieved better outcomes at a lower cost per improvement in neurological and functional scores than traditional treatment alone.
[Efficacy of cereton in acute ischemic stroke: results of the trial SOLNTSE].Kamchatnov, PR., Abusueva, BA., Evzel'man, MA., et al.[2016]
Cervene (nalmefene) was found to be safe and well-tolerated in a randomized trial involving 44 patients treated within 6 hours of an acute ischemic stroke, with no deaths or serious adverse events linked to the drug.
Patients treated with Cervene showed a significantly higher rate of major improvement in stroke severity (66% vs. 33% for placebo) and better recovery outcomes at 3 months (73% vs. 50% for placebo), suggesting potential efficacy in stroke treatment.
Randomized trial of Cervene, a kappa receptor-selective opioid antagonist, in acute ischemic stroke.Clark, WM., Coull, BM., Karukin, M., et al.[2019]

References

A systematic review of vinpocetine therapy in acute ischaemic stroke. [2019]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Efficacy of cereton in acute ischemic stroke: results of the trial SOLNTSE]. [2016]
Randomized trial of Cervene, a kappa receptor-selective opioid antagonist, in acute ischemic stroke. [2019]
4.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Drug rehabilitation in stroke patients]. [2016]
Stroke: posthospital management and recurrence prevention. [2016]
A randomized, controlled pilot study of a home-based exercise program for individuals with mild and moderate stroke. [2022]
Access, timing and frequency of very early stroke rehabilitation - insights from the Baden-Wuerttemberg stroke registry. [2018]
Determining Maximal Tolerable Aerobic Training Intensity in the Acute Phase after Stroke: a Novel Dose Ranging Trial Protocol. [2022]
Little therapy, little physical activity: rehabilitation within the first 14 days of organized stroke unit care. [2022]
International consensus recommendations for outcome measurement in post-stroke arm rehabilitation trials. [2021]