Using Maraviroc and exercise to improve recovery after stroke
The CAMAROS Trial: The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
This study is testing if the medication Maraviroc, along with an exercise program, can help people recover better after having a stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT04789616 on ClinicalTrials.gov |
What this trial studies
The CAMAROS trial is a phase II randomized controlled trial that investigates the effects of the CCR5 antagonist Maraviroc combined with an exercise rehabilitation program on recovery outcomes for stroke patients. Participants will be enrolled within 8 weeks of experiencing a primary ischemic anterior circulation stroke and will be randomly assigned to receive either Maraviroc or a placebo alongside standard rehabilitation. The study aims to evaluate improvements in motor and cognitive functions through physical assessments and activity sensors over the course of the intervention. This innovative approach seeks to extend the recovery period beyond the typical plateau observed after stroke rehabilitation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced a primary ischemic anterior circulation stroke and require inpatient rehabilitation.
Not a fit: Patients who are not within 8 weeks post-stroke or those with severe limitations in motor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery outcomes for stroke patients, potentially leading to improved motor and cognitive function.
How similar studies have performed: While some studies have explored the use of medications to enhance rehabilitation outcomes, the specific combination of Maraviroc with exercise in stroke recovery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Primary ischemic anterior circulation stroke
2. Age ≥18 years
3. At least 5 days after stroke but within 8 weeks of stroke on the date of medication (maraviroc or placebo) start
4. Hemiparesis requiring inpatient rehabilitation
5. Assistance available for daily rehabilitation training practice and for transportation when needed
6. Adequate language skills to understand the Informed Consent and retain information during daily therapies
7. At least one of the following:
* some shoulder abduction with gravity eliminated and visible extension in two or more digits OR
* visible hip flexion or extension
Subgroup Stratification Criteria
1. For Upper Extremity Group:
* Minimum Ability: Medical Research Council (MRC) grade \>1 for shoulder abduction AND MRC grade \>1 for finger extensor on at least two digits
* Maximum Ability: Upper Extremity Fugl-Meyer Assessment Score \>56
2. For Lower Extremity Group:
* Minimum Ability: requiring a 2-person assist
* Maximum Ability: walking speed \<0.8m/s
Exclusion Criteria:
1. Pre-stroke modified Rankin score ≥ 2
2. Limited resources or illness that will not enable a return to living outside of a facility
3. History of dementia
4. History of hepatitis or elevated hepatic transaminases or bilirubin
5. History of renal insufficiency or creatinine clearance (eGFR) \< 60mL / min / 1.73m2
6. Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
7. Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)
8. Seizure related to stroke
9. Acute or chronic epilepsy
10. Currently taking any of the following anticonvulsant medications:
* Carbamazepine
* Phenobarbital
* Phenytoin
11. Pregnant, breastfeeding, or positive test for pregnancy at baseline
12. Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
13. Known HIV positivity
14. Currently taking any of the following antifungal and/or antibacterial medications:
* Ketoconazole
* Itraconazole
* Voriconazole
* Rifampin
* Clarithromycin
* Rifabutin + Protease Inhibitor
15. Currently taking St. John's Wort
16. Currently taking Paxlovid
Where this trial is running
Calgary, Alberta and 5 other locations
- University of Calgary & Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- University of British Columbia & GF Strong Rehabilitation Centre — Vancouver, British Columbia, Canada (Recruiting)
- Dalhousie University — Halifax, Nova Scotia, Canada (Recruiting)
- Parkwood Institute — London, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
- Toronto Rehabilitation Institute - University Health Network — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Sean Dukelow, MD PhD FRCPC — University of Calgary
- Study coordinator: Alexandra McKinnon
- Email: alexandra.mckinnon@ucalgary.ca
- Phone: 403-944-4050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.