StrokeEarly Phase 1NCT07588932
Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors
A Early Phase 1 study testing Telmisartan, Metformin, Cilostazol in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The goal of this trial is to study if the concomitant administration of Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) can help stroke survivors make greater gains in movement and recovery during robot-assisted arm and hand rehabilitation. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Telmisartan, Metformin, Cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 21 and 80 years of age.
- History of ischemic stroke.
- Stroke occurred at least six months prior to recruitment.
- Moderate to severe UE impairment (FMA-UE score between 15 and 40)
- MMSE score >=20 and being able to safely follow three-step commands.
Who cannot join
- Contraindications to the pharmacotherapy (e.g., heart failure, known medication reaction or interactions with ongoing medication regimen).
- Taking dual antiplatelet therapy (e.g., Aspirin+Plavix) and/or other anticoagulation medications (e.g., Eliquis, coumadin) that cannot safely be modified or discontinued (as determined by the participant's primary care physician or by the medical monitor).
- Clinically significant somnolence and/or depression that would hinder active participation in motor training sessions.
- Taking any medication that the study physician determines to have a significant drug-drug interaction with Telmisartan, Cilostazol, and/or Metformin.
- Taking Telmisartan, Cilostazol, and/or Metformin in a dose that is different from the one used in the study and that cannot be adjusted to match the study dose (as determined by the participant's primary care physician or by the medical monitor).
- Taking medications with equivalent clinical effect (e.g., BP control) to Telmisartan, Cilostazol, and/or Metformin and that cannot be replaced by Telmisartan, Cilostazol, and/or Metformin (as determined by the participant's primary care physician or by the medical monitor).
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- A body mass index (BMI) below 25 (as the proposed pharmacotherapy could cause hypoglycemia in participants with normal-low BMI).
- Severe musculoskeletal pathology or recent fractures affecting the impaired UE that would prevent safe use of the rehabilitation robotic system.
- Previous diagnosis of neurological diseases other than stroke that would have a negative impact on the response to the rehabilitation intervention (e.g., severe dystonia affecting the UE) or would prevent safe participation in RA UE training (e.g., uncontrolled seizures).
- Moderate to severe disability due to migraines as determined using the Migraine Disability Assessment test (score > 10).
- Severe spasticity (Modified Ashworth Scale for spasticity ≥ 3 for UE muscles) that would prevent safe use of the robotic system utilized during training.
- Undergoing Botox treatment for pain/spasticity related to the affected upper extremity, in the 4 months prior to enrollment or during the study period.
- Cerebellar and/or hemorrhagic stroke.
- Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally.
- Visual impairments that would prevent proper use of interactive on-screen games during RA UE training.
- Severe hemispatial neglect as assessed using the Line Bisection Test (missed lines >2).
- Severely impaired trunk control that would prevent sitting safely on a chair without arms.
- Individuals who present with the following on the impaired UE: open wounds, fragile skin, and under contact precautions due to an active infection.
- Participation in another therapy focused on the recovery of the impaired UE.
- Subjects with cardiac pacemakers, electronic pumps, or any other implanted medical devices that are not US-certified (and hence might be affected by the electromagnetic interference generated by the robot).
- Any condition that would prevent proper/safe use of the robotic system, such as proprioceptive deficits that impair the ability to process haptic or visual feedback, or unstable shoulder joint as assessed by physical examination.
- Current pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
Paolo Bonato, PhD, 617-952-6388, pbonato@mgh.harvard.edu
Federico De Carlo, MS, 617-952-6388, fdecarlo@mgb.org
About this study
Official title: Relying on Pharmacotherapy to Improve Motor Gains of Robot-Assisted Upper-Extremity Rehabilitation in Chronic Stroke Survivors
The goal of this trial is to study if the concomitant administration of Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) can help stroke survivors make greater gains in movement and recovery during robot-assisted arm and hand rehabilitation.
Read the detailed description
The overall objective of the proposed study is to assess the viability of a pharmacotherapy combining Telmisartan, Cilostazol IR, and Metformin ER to affect the motor gains achieved via robot-assisted (RA) upper-extremity (UE) rehabilitation in stroke survivors. The hypothesis underlying the study design is that concomitant administration of Telmisartan, Cilostazol IR, and Metformin ER (herein referred to as "the proposed pharmacotherapy") leads to enhancing motor and non-motor gains observed in stroke survivors in response to RA UE rehabilitation. Participants will take these medications either once a day (QD) or twice a day (BID) as described in the protocol.
To test this hypothesis, we plan to accomplish the following primary and secondary aims.
Primary Aims:
- 1 To determine if administration of the proposed pharmacotherapy in combination with RA UE rehabilitation leads to greater improvements in UE motor impairment than previously observed in clinical trials relying on RA UE rehabilitation alone.
- 2 To evaluate potential adverse events when using the proposed pharmacotherapy in combination with RA UE rehabilitation.
Secondary Aim:
#1 To determine if the proposed pharmacotherapy in combination with RA UE rehabilitation improves UE functional ability, health related quality of life, and cognition.
Exploratory Aims:
- 1 To determine the association between response to the proposed pharmacotherapy and serum-based biomarkers collected at baseline (i.e., evaluation session prior to training), during the first training session (beginning and end of the session), during the last training session (beginning and end of the session), and during the 3-month follow-up evaluation session.
- 2 To evaluate the retention of motor and cognitive gains at 1-month post-intervention.
- Conditions
- Stroke
- Being tested
- Telmisartan, Metformin, Cilostazol
- Keywords
- Stroke, Rehabilitation, Pharmacotherapy, Robotic therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan, Metformin, CilostazolDrug
Also called Proposed pharmacotherapy
Participants will be instructed to take the low dose of the proposed pharmacotherapy (i.e., Telmisartan 20mg QD, Metformin ER 500mg QD, Cilostazol IR 50mg QD) during week 1 and the full dose (i.e., Telmisartan 40mg QD, Metformin ER 500mg BID, Cilostazol IR 50mg BID) starting on week 2. They will continue to take the full dose until completion of the six-week robot assessed upper extremity training period (week 3-8). At the end of this period, they will be instructed to take the low dose of the proposed pharmacotherapy for two more weeks. During the entire study, participants will be monitored for potential side-effects.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be instructed to take Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) (herein referred to as "proposed pharmacotherapy") while undergoing robot-assisted upper-extremity training. Participants will take these medications either once a day (QD) or twice a day (BID) as described in the protocol. Receives: Drug: Telmisartan, Metformin, Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
The FMA-UE is a widely used, standardized test that measures movement, coordination, and reflexes of the arm, wrist, and hand after a stroke. Scores reflect the degree of motor impairment, with higher scores indicating better motor function (range 0-66).
Measured: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study
Secondary outcomes (3)
Action Research Arm Test (ARAT)
The ARAT is a standardized test of upper limb function after stroke. It assesses the ability to grasp, grip, pinch, and move objects, with higher scores indicating better arm and hand function (range 0 to 57).
Measured: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study.
Stroke Impact Scale (SIS)
The SIS is a self-reported questionnaire that measures how stroke has affected daily activities, mobility, communication, emotion, memory, and quality of life. Higher scores reflect better function and well-being (range 0 to 100)
Measured: Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.
Mini Mental State Exam (MMSE scale)
An 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language (range 0 to 30).
Measured: Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start18 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neuro-Innovators, Inc.
- Responsible party
- Principal investigator, Qing Mei Wang, M.D., Spaulding Rehabilitation Hospital
- Investigators
- Qing M Wang, MD, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588932
- Sponsor's protocol ID
- 2024P003711
- Status last verified
- Jul 2026
- First submitted
- 9 May 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and secondary outcome measures will be shared via publications (de-identified individual participant data will be included in the Supplementary Materials section of the manuscript).
Publications
Ahn CM, Hong SJ, Park JH, Kim JS, Lim DS. Cilostazol reduces the progression of carotid intima-media thickness without increasing the risk of bleeding in patients with acute coronary syndrome during a 2-year follow-up. Heart Vessels. 2011 Sep;26(5):502-10. doi: 10.1007/s00380-010-0093-1. Epub 2010 Dec 9.
PubMed 21153029Akhtar N, Singh R, Kamran S, Babu B, Sivasankaran S, Joseph S, Morgan D, Shuaib A. Diabetes: Chronic Metformin Treatment and Outcome Following Acute Stroke. Front Neurol. 2022 Apr 26;13:849607. doi: 10.3389/fneur.2022.849607. eCollection 2022.
PubMed 35557626Arbelaez-Quintero I, Palacios M. To Use or Not to Use Metformin in Cerebral Ischemia: A Review of the Application of Metformin in Stroke Rodents. Stroke Res Treat. 2017;2017:9756429. doi: 10.1155/2017/9756429. Epub 2017 May 28.
PubMed 28634570Bourget C, Adams KV, Morshead CM. Reduced microglia activation following metformin administration or microglia ablation is sufficient to prevent functional deficits in a mouse model of neonatal stroke. J Neuroinflammation. 2022 Jun 15;19(1):146. doi: 10.1186/s12974-022-02487-x.
PubMed 35705953Brown T, Forster RB, Cleanthis M, Mikhailidis DP, Stansby G, Stewart M. Cilostazol for intermittent claudication. Cochrane Database Syst Rev. 2021 Jun 30;6(6):CD003748. doi: 10.1002/14651858.CD003748.pub5.
PubMed 34192807Choi BR, Kim DH, Back DB, Kang CH, Moon WJ, Han JS, Choi DH, Kwon KJ, Shin CY, Kim BR, Lee J, Han SH, Kim HY. Characterization of White Matter Injury in a Rat Model of Chronic Cerebral Hypoperfusion. Stroke. 2016 Feb;47(2):542-7. doi: 10.1161/STROKEAHA.115.011679. Epub 2015 Dec 15.
PubMed 26670084Deguchi I, Furuya D, Fukuoka T, Tanahashi N. Effects of telmisartan on the cerebral circulation of hypertensive patients with chronic-stage stroke. Hypertens Res. 2012 Dec;35(12):1171-5. doi: 10.1038/hr.2012.105. Epub 2012 Jul 5.
PubMed 22763480Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.
PubMed 15843670Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997 Dec;103(6):491-7. doi: 10.1016/s0002-9343(97)00254-4.
PubMed 9428832Grissi M, Boudot C, Assem M, Candellier A, Lando M, Poirot-Leclercq S, Boullier A, Bennis Y, Lenglet G, Avondo C, Lalau JD, Choukroun G, Massy ZA, Kamel S, Chillon JM, Henaut L. Metformin prevents stroke damage in non-diabetic female mice with chronic kidney disease. Sci Rep. 2021 Apr 2;11(1):7464. doi: 10.1038/s41598-021-86905-9.
PubMed 33811249Iwanami J, Mogi M, Tsukuda K, Min LJ, Sakata A, Jing F, Iwai M, Horiuchi M. Low dose of telmisartan prevents ischemic brain damage with peroxisome proliferator-activated receptor-gamma activation in diabetic mice. J Hypertens. 2010 Aug;28(8):1730-7. doi: 10.1097/HJH.0b013e32833a551a.
PubMed 20498620Jin Q, Cheng J, Liu Y, Wu J, Wang X, Wei S, Zhou X, Qin Z, Jia J, Zhen X. Improvement of functional recovery by chronic metformin treatment is associated with enhanced alternative activation of microglia/macrophages and increased angiogenesis and neurogenesis following experimental stroke. Brain Behav Immun. 2014 Aug;40:131-42. doi: 10.1016/j.bbi.2014.03.003. Epub 2014 Mar 12.
PubMed 24632338Jung KH, Chu K, Lee ST, Kim SJ, Song EC, Kim EH, Park DK, Sinn DI, Kim JM, Kim M, Roh JK. Blockade of AT1 receptor reduces apoptosis, inflammation, and oxidative stress in normotensive rats with intracerebral hemorrhage. J Pharmacol Exp Ther. 2007 Sep;322(3):1051-8. doi: 10.1124/jpet.107.120097. Epub 2007 May 30.
PubMed 17538008Kim YR, Kim HN, Hong KW, Shin HK, Choi BT. Anti-depressant effects of phosphodiesterase 3 inhibitor cilostazol in chronic mild stress-treated mice after ischemic stroke. Psychopharmacology (Berl). 2016 Mar;233(6):1055-66. doi: 10.1007/s00213-015-4185-6. Epub 2015 Dec 21.
PubMed 26686236Kim YR, Kim HN, Hong KW, Shin HK, Choi BT. Antidepressant Effects of Aripiprazole Augmentation for Cilostazol-Treated Mice Exposed to Chronic Mild Stress after Ischemic Stroke. Int J Mol Sci. 2017 Feb 8;18(2):355. doi: 10.3390/ijms18020355.
PubMed 28208711
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relying on Pharmacotherapy to Improve Motor Gains of Robot-Assisted Upper-Extremity Rehabilitation in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT07588932
- Acronym / sponsor ID
- 2024P003711
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Pharmacotherapy, Robotic therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Neuro-Innovators, Inc.
- Study start
- 18 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to study if the concomitant administration of Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) can help stroke survivors make greater gains in movement and recovery during robot-assisted arm and hand rehabilitation.
Detailed description
The overall objective of the proposed study is to assess the viability of a pharmacotherapy combining Telmisartan, Cilostazol IR, and Metformin ER to affect the motor gains achieved via robot-assisted (RA) upper-extremity (UE) rehabilitation in stroke survivors. The hypothesis underlying the study design is that concomitant administration of Telmisartan, Cilostazol IR, and Metformin ER (herein referred to as "the proposed pharmacotherapy") leads to enhancing motor and non-motor gains observed in stroke survivors in response to RA UE rehabilitation. Participants will take these medications either once a day (QD) or twice a day (BID) as described in the protocol.
To test this hypothesis, we plan to accomplish the following primary and secondary aims.
Primary Aims:
- 1 To determine if administration of the proposed pharmacotherapy in combination with RA UE rehabilitation leads to greater improvements in UE motor impairment than previously observed in clinical trials relying on RA UE rehabilitation alone.
- 2 To evaluate potential adverse events when using the proposed pharmacotherapy in combination with RA UE rehabilitation.
Secondary Aim:
#1 To determine if the proposed pharmacotherapy in combination with RA UE rehabilitation improves UE functional ability, health related quality of life, and cognition.
Exploratory Aims:
- 1 To determine the association between response to the proposed pharmacotherapy and serum-based biomarkers collected at baseline (i.e., evaluation session prior to training), during the first training session (beginning and end of the session), during the last training session (beginning and end of the session), and during the 3-month follow-up evaluation session.
- 2 To evaluate the retention of motor and cognitive gains at 1-month post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Telmisartan, Metformin, CilostazolParticipants will be instructed to take Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) (herein referred to as "proposed pharmacotherapy") while undergoing robot-assisted upper-extremity training. Participants will take these medications either once a day (QD) or twice a day (BID) as described in the protocol. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults between 21 and 80 years of age.
- History of ischemic stroke.
- Stroke occurred at least six months prior to recruitment.
- Moderate to severe UE impairment (FMA-UE score between 15 and 40)
- MMSE score >=20 and being able to safely follow three-step commands.
Key exclusion criteria (22 listed)
- Contraindications to the pharmacotherapy (e.g., heart failure, known medication reaction or interactions with ongoing medication regimen).
- Taking dual antiplatelet therapy (e.g., Aspirin+Plavix) and/or other anticoagulation medications (e.g., Eliquis, coumadin) that cannot safely be modified or discontinued (as determined by the participant's primary care physician or by the medical monitor).
- Clinically significant somnolence and/or depression that would hinder active participation in motor training sessions.
- Taking any medication that the study physician determines to have a significant drug-drug interaction with Telmisartan, Cilostazol, and/or Metformin.
- Taking Telmisartan, Cilostazol, and/or Metformin in a dose that is different from the one used in the study and that cannot be adjusted to match the study dose (as determined by the participant's primary care physician or by the medical monitor).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan, Metformin, CilostazolAlso: Proposed pharmacotherapyParticipants will be instructed to take the low dose of the proposed pharmacotherapy (i.e., Telmisartan 20mg QD, Metformin ER 500mg QD, Cilostazol IR 50mg QD) during week 1 and the full dose (i.e., Telmisartan 40mg QD, Metformin ER 500mg BID, Cilostazol IR 50mg BID) starting on week 2. They will continue to take the full dose until completion of the six-week robot assessed upper extremity training period (week 3-8). At the end of this period, they will be instructed to take the low dose of the proposed pharmacotherapy for two more weeks. During the entire study, participants will be monitored for potential side-effects. | Drug | Intervention |
Primary outcome
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time frame: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study
The FMA-UE is a widely used, standardized test that measures movement, coordination, and reflexes of the arm, wrist, and hand after a stroke. Scores reflect the degree of motor impairment, with higher scores indicating better motor function (range 0-66).
3 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study.
Stroke Impact Scale (SIS)
Time frame: Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.
Mini Mental State Exam (MMSE scale)
Time frame: Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 21153029Ahn CM, Hong SJ, Park JH, Kim JS, Lim DS. Cilostazol reduces the progression of carotid intima-media thickness without increasing the risk of bleeding in patients with acute coronary syndrome during a 2-year follow-up. Heart Vessels. 2011 Sep;26(5):502-10. doi: 10.1007/s00380-010-0093-1. Epub 2010 Dec 9.
- Background: PubMed 35557626Akhtar N, Singh R, Kamran S, Babu B, Sivasankaran S, Joseph S, Morgan D, Shuaib A. Diabetes: Chronic Metformin Treatment and Outcome Following Acute Stroke. Front Neurol. 2022 Apr 26;13:849607. doi: 10.3389/fneur.2022.849607. eCollection 2022.
- Background: PubMed 28634570Arbelaez-Quintero I, Palacios M. To Use or Not to Use Metformin in Cerebral Ischemia: A Review of the Application of Metformin in Stroke Rodents. Stroke Res Treat. 2017;2017:9756429. doi: 10.1155/2017/9756429. Epub 2017 May 28.
- Background: PubMed 35705953Bourget C, Adams KV, Morshead CM. Reduced microglia activation following metformin administration or microglia ablation is sufficient to prevent functional deficits in a mouse model of neonatal stroke. J Neuroinflammation. 2022 Jun 15;19(1):146. doi: 10.1186/s12974-022-02487-x.
- Background: PubMed 34192807Brown T, Forster RB, Cleanthis M, Mikhailidis DP, Stansby G, Stewart M. Cilostazol for intermittent claudication. Cochrane Database Syst Rev. 2021 Jun 30;6(6):CD003748. doi: 10.1002/14651858.CD003748.pub5.
- Background: PubMed 26670084Choi BR, Kim DH, Back DB, Kang CH, Moon WJ, Han JS, Choi DH, Kwon KJ, Shin CY, Kim BR, Lee J, Han SH, Kim HY. Characterization of White Matter Injury in a Rat Model of Chronic Cerebral Hypoperfusion. Stroke. 2016 Feb;47(2):542-7. doi: 10.1161/STROKEAHA.115.011679. Epub 2015 Dec 15.
- Background: PubMed 22763480Deguchi I, Furuya D, Fukuoka T, Tanahashi N. Effects of telmisartan on the cerebral circulation of hypertensive patients with chronic-stage stroke. Hypertens Res. 2012 Dec;35(12):1171-5. doi: 10.1038/hr.2012.105. Epub 2012 Jul 5.
- Background: PubMed 15843670Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.
- Background: PubMed 9428832Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997 Dec;103(6):491-7. doi: 10.1016/s0002-9343(97)00254-4.
- Background: PubMed 33811249Grissi M, Boudot C, Assem M, Candellier A, Lando M, Poirot-Leclercq S, Boullier A, Bennis Y, Lenglet G, Avondo C, Lalau JD, Choukroun G, Massy ZA, Kamel S, Chillon JM, Henaut L. Metformin prevents stroke damage in non-diabetic female mice with chronic kidney disease. Sci Rep. 2021 Apr 2;11(1):7464. doi: 10.1038/s41598-021-86905-9.
- Background: PubMed 20498620Iwanami J, Mogi M, Tsukuda K, Min LJ, Sakata A, Jing F, Iwai M, Horiuchi M. Low dose of telmisartan prevents ischemic brain damage with peroxisome proliferator-activated receptor-gamma activation in diabetic mice. J Hypertens. 2010 Aug;28(8):1730-7. doi: 10.1097/HJH.0b013e32833a551a.
- Background: PubMed 24632338Jin Q, Cheng J, Liu Y, Wu J, Wang X, Wei S, Zhou X, Qin Z, Jia J, Zhen X. Improvement of functional recovery by chronic metformin treatment is associated with enhanced alternative activation of microglia/macrophages and increased angiogenesis and neurogenesis following experimental stroke. Brain Behav Immun. 2014 Aug;40:131-42. doi: 10.1016/j.bbi.2014.03.003. Epub 2014 Mar 12.
- Individual participant dataSharing planned: Yes. Primary and secondary outcome measures will be shared via publications (de-identified individual participant data will be included in the Supplementary Materials section of the manuscript).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qing M Wang, MD, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Telmisartan, Metformin, Cilostazol in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Costa, OT (617-952-6388, mcosta11@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07588932, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.