Telmisartan + Metformin + Cilostazol for Stroke

MC
EF
Overseen ByErin Foley, OT
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Spaulding Rehabilitation Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of three medications—Telmisartan, Metformin, and Cilostazol—can enhance recovery for stroke survivors during robotic-assisted rehab for their arms and hands. The goal is to determine if these medications can improve movement and recovery. Individuals who experienced an ischemic stroke over six months ago and still face significant arm and hand movement issues might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, providing participants an opportunity to explore new recovery options.

Will I have to stop taking my current medications?

You might need to stop or adjust some of your current medications if they interact with the trial drugs or if you're taking similar medications that can't be replaced by the trial drugs. It's best to discuss this with your doctor to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Telmisartan, Cilostazol, and Metformin together is generally safe. Studies indicate that people tolerate this combination well, with few serious side effects. For instance, Cilostazol can help prevent more strokes without causing major heart problems like heart attacks or additional strokes. Telmisartan and Metformin are also widely used for other health issues, supporting their overall safety. This trial is in its early stages and aims to gather more detailed safety information. However, current evidence suggests that this mix of drugs is safe.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment because it combines Telmisartan, Metformin, and Cilostazol, offering a unique approach to stroke recovery. Unlike the standard treatments that typically focus on blood pressure control or blood thinning separately, this combination targets multiple pathways simultaneously. Telmisartan helps manage blood pressure, Metformin is known for its effects on metabolism and vascular health, and Cilostazol can improve blood flow and prevent clots. This multi-targeted strategy, paired with robot-assisted therapy, could enhance recovery outcomes more effectively than current single-focus treatments.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research has shown that using Telmisartan, Metformin, and Cilostazol together might aid stroke survivors in their recovery. In this trial, participants will receive a combination of these medications as part of the intervention. Cilostazol reduces the risk of another stroke by decreasing blood clots and has been found to improve blood flow to the brain, aiding recovery. Metformin helps control blood sugar, which might also support brain health. Telmisartan is often used to lower blood pressure, which can decrease stroke risk. While these results are encouraging, further research is needed to confirm how well these drugs work together to improve movement recovery after a stroke.23467

Who Is on the Research Team?

QM

Qing M Wang, MD, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 who had an ischemic stroke at least six months ago and now have moderate to severe arm or hand weakness. Participants must be able to follow instructions safely and have no major cognitive problems.

Inclusion Criteria

I have had an ischemic stroke in the past.
I can follow instructions and scored at least 20 on the MMSE test.
I had a stroke more than six months ago.
See 2 more

Exclusion Criteria

I am taking blood thinners that cannot be safely stopped or changed.
My BMI is below 25.
I take Telmisartan, Cilostazol, or Metformin at a dose that cannot be changed for the study.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the proposed pharmacotherapy in combination with robot-assisted upper-extremity rehabilitation

12 weeks
Weekly visits for rehabilitation sessions

Follow-up

Participants are monitored for retention of motor and cognitive gains post-intervention

1 month
1 visit (in-person) at 1-month post-intervention

What Are the Treatments Tested in This Trial?

Interventions

  • Cilostazol
  • Metformin
  • Telmisartan

Trial Overview

The study tests if taking Telmisartan, Metformin, and Cilostazol together can help improve movement recovery in stroke survivors during robot-assisted arm and hand rehab.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials
143
Recruited
11,200+

Neuro-Innovators, Inc.

Industry Sponsor

Citations

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The overall objective of the proposed study is to assess the viability of a pharmacotherapy combining Telmisartan, Cilostazol IR, and Metformin ...

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