Recruiting
Phase 2

Maraviroc

Sponsor:

University of Calgary

Code:

NCT04789616

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Maraviroc

Exercise Program

Placebo

Activity Sensor

Motor Learning

Study Details

Brief summary:

The CAMAROS trial is a randomized controlled phase II trial analyzing the effect of coupling a C-C chemokine receptor 5 (CCR5) antagonist, Maraviroc (Celsentri), and exercise to improve both upper and lower extremity recovery after a stroke.

Conditions

Stroke

Study ID

NCT04789616

Start date

Sep 15, 2022

Status verified date

Jul, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maraviroc (Celsentri)

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).

placebo comparator: Placebo

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).

Interventions

Maraviroc

Half of the participants will take maraviroc for a period of 8 weeks.

Exercise Program

All participants will take part in an 8-week exercise program. While in-hospital, participants will undergo standard of care rehabilitation (estimated at 45 minutes each daily for physiotherapy \& occupational therapy) plus a supplementary upper extremity exercise program (Graded Repetitive Arm Supplementary Program (GRASP); estimated at 1 hour daily).

After discharge from inpatient care, participants will complete an at-home supplementary upper and lower extremity exercise program. This program will include 30 minutes daily walking or sit-to-stand exercises and 30 minutes daily practice using the GRASP program.

Placebo

Half of the participants will take a placebo for a period of 8 weeks.

Activity Sensor

Participants will be asked to wear small activity sensors (one on each wrist and one on each ankle, total of four sensors) at the baseline, 4-week, 8-week, and 6-month assessments for 7 consecutive days. Activity related to walking, sleep, physical activity, and arm and leg movement throughout the day will be measured.

The sensors will be worn for a total of 28 days throughout the study.

Motor Learning

Participants will be asked to perform a computer-based motor learning assessment at the baseline, 4-week, 8-week, and 6-month assessments. A retention task, which involves shorter versions of the initial tasks, will also be completed within 72 hours of the initial assessment (initial test and retention test).

Primary outcome measure

  • Change in Fugl-Meyer Upper Extremity Assessment Score [ Time Frame: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke ]
  • Change in 10-Meter Walk Test Score [ Time Frame: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke ]

Central Contacts and Locations

Locations

University of Calgary & Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Principal Investigator:

Gentson Leung, MD

University of British Columbia & GF Strong Rehabilitation Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 2G9

Contacts

Principal Investigator:

Janice Eng, PhD

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, B3H 3J5

Contacts

Principal Investigator:

Marilyn Mackay-Lyons, PhD

Parkwood Institute

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

Principal Investigator:

Robert Teasell, MD

More Information

Sponsor

University of Calgary

Last update posted

Jul 9, 2024

Last verified

Jul, 2024

Keywords

  • Rehabilitation
  • Exercise
  • Maraviroc
  • Randomized Control Trial
  • Activity Sensors
  • Motor Learning
  • Retention
  • Wearable Sensors
  • Celsentri

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-07-09.