Chronic StrokePhase 2RIMOSTROKE-1NCT07913763
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
A Phase 2 study testing Rimonabant in people with Chronic Stroke, run by Sinfatin S.L at 6 sites in Spain.
Trial summary
The mail goal of this clinical trial is assess the effect of rimonabant in walking ability in people who experienced a stroke at least 12 months before enrollment. It will include 80 adults aged 18 to 75 years that will receive either rimonabant (5 mg) or placebo (a look-alike tablet that contains no drug) once daily… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 6 sitesSpain
- Study dates
- 30 Nov 2026to 31 Dec 2028
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- More than 12 months since diagnosis of stroke (chronic phase).
- Modified Rankin Scale score between 2 and 4.
- Ability to walk at least 5 meters with or without assistance.
- Capacity to provide written informed consent.
- Preserved cognitive functions to adequately comply with study assessments.
Who cannot join
- High risk of suicide as assessed by the C-SSRS scale.
- History of severe psychiatric disorders, major depression or prior suicide attempts.
- Treatment with anticoagulants or strong CYP3A4 inhibitors or inducers (inhibitors such as ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, or nefazodone, and inducers such as rifampicin, phenytoin, phenobarbital, carbamazepine, or St. John's Wort).
- Body Mass Index (BMI) > 40 kg/m².
- Pregnancy or breastfeeding.
- Fertile men or women who cannot guarantee the use of highly effective contraceptive methods, as defined by the European HMA-CTFG guidelines at least 45 days after the last dose of rimonabant -i.e., those with a failure rate of less than 1 % per year when used consistently and correctly (CTFG, 2020).
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- Uncontrolled hypothyroidism, or a history of severe bone, liver, or kidney disease.
- Inability to attend hospital visits.
- Known allergy to rimonabant or any of the excipients used.
- Participation in another clinical trial within the month prior to enrolment.
- Any other condition that, in the opinion of the investigator, makes the subject's participation in the study unrecommended, such as severe heart failure or uncontrolled diabetes.
- COPD or other severe chronic respiratory disease, chronic fatigue syndrome, severe congestive heart failure, orthopaedic ambulatory impediments (like severe arthritis) or other comorbidities that, according to the investigator's judgement, may substantially limit walking performance independently of stroke-related impediments.
- Impaired walking capabilities with a baseline 6MWT distance ≥400 m.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites
Hospital Universitario de Albacete
Albacete, Albacete, 02006
Carlos Manuel Romero-Sánchez, MD, +34967597165, ensayosalbacete@gmail.com
Institut Guttmann
Badalona, Barcelona, 08916
Sergi Albu, MD, PhD, +34934977700, salbu@guttmann.com
Hospital Los Madroños
Brunete, Madrid, 28690
Natacha León, MD, PhD, +34918163526, natacha.leon@lmh.es
Jiménez Lucena S.L. (CLÍNICA I+TÚ)
Córdoba, Córdoba, 14004
Maria Dolores Naranjo, MD, +34857831780, lolanaranjoramirez@gmail.com
Hospital Clínico San Carlos (HCSC)
Madrid, Madrid, 28040
Jordi Matias-Guiu, MD, PhD, +34913303000, jordimatiasguiu@hotmail.com
Hospital Universitario La Paz
Madrid, Madrid, 28046
Blanca Fuentes, MD, PhD, +34917277000, blanca.fuentes@salud.madrid.org
About this study
Official title: Effects of a CB1 Receptor Antagonist/Inverse Agonist (Rimonabant) on Walking Ability in Patients in the Chronic Phase of Stroke (RIMOSTROKE-1)
The mail goal of this clinical trial is assess the effect of rimonabant in walking ability in people who experienced a stroke at least 12 months before enrollment.
It will include 80 adults aged 18 to 75 years that will receive either rimonabant (5 mg) or placebo (a look-alike tablet that contains no drug) once daily for 90 days. Neither the participants nor the investigators will know which treatment is being given.
The study will also help to learn about the safety of rimonabant.
Read the detailed description
Stroke is a major cause of long-term disability, and many patients experience persistent walking impairments despite rehabilitation. These limitations can significantly affect independence, mobility, and quality of life.
The endocannabinoid system, particularly the cannabinoid type 1 (CB1) receptor, is involved in the regulation of neuronal activity and motor function. Rimonabant is a selective CB1 receptor antagonist/inverse agonist that has demonstrated effects on corticospinal excitability and motor performance in previous preclinical and clinical research. Findings from studies involving patients with incomplete spinal cord injury suggest that low doses of rimonabant may have potential benefits for motor function.
Based on this evidence, RIMOSTROKE-1 aims to investigate whether treatment with low-dose rimonabant can improve walking ability in patients with chronic stroke.
RIMOSTROKE-1 is a randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of rimonabant 5 mg administered orally once daily compared with placebo. Participants will receive treatment for 90 days, followed by a 30-day follow-up period.
The primary objective is to evaluate the effect of rimonabant on walking capacity, measured by the percentage change in distance covered during the Six-Minute Walk Test (6MWT) from baseline to Day 90.
The study will also evaluate additional measures of motor function and safety, including the occurrence of adverse events and psychiatric safety assessments.
This study seeks to determine whether low-dose CB1 receptor modulation could represent a potential therapeutic approach to improving walking ability in patients with chronic stroke.
- Conditions
- Chronic Stroke
- Being tested
- Rimonabant, Placebo
- Keywords
- Rimonabant, CB1 receptor antagonist, Stroke rehabilitation, Motor recovery, Six-Minute Walk Test, Chronic stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Rimonabant 5 mg administered orally as one orally disintegrating tablet (ODT) once daily for 90 consecutive days.
PlaceboDrug
Participants will receive one matching placebo orally disintegrating tablet (ODT) once daily for 90 consecutive days. The placebo contains no rimonabant.
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant 5 mg | Experimental | Participants randomized to receive rimonabant 5 mg. Receives: Drug: Rimonabant |
| Placebo | Placebo comparator | Participants randomized to receive matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test (6MWT)
The 6MWT assesses walking capacity by measuring the distance walked in six minutes, expressed in meters. The primary endpoint is the percentage change in walking distance from baseline to the end of follow-up on day 135. Greater distances indicate better walking capacity.
Measured: Baseline to end of follow-up (day 135)
Secondary outcomes (19)
Six-Minute Walk Test (6MWT) -EOT
The 6MWT assesses walking capacity by measuring the distance walked in six minutes, expressed in meters. The percentage change in walking distance from baseline to the end of treatment at day 90. Greater distances indicate better walking capacity.
Measured: Baseline to end of treatment (day 90)
Borg CR10 Scale
The Borg CR10 Scale assesses perceived exertion after the 6MWT. Scores range from 0 (no exertion) to 10 (maximal exertion). Higher scores indicate greater perceived exertion.
Measured: Baseline to end of follow-up (day 135)
6MWT Clinically Relevant Improvement
The number of participants achieving a clinically relevant improvement in walking distance, defined as an increase of more than 40 meters or more than 25% compared with baseline.
Measured: Baseline to end of follow-up (day 135)
Ten-Meter Walk Test (10MWT)
The Ten-Meter Walk Test (10MWT) assesses walking performance by measuring the time required to walk 10 meters at a comfortable or maximal pace. Shorter completion times indicate faster walking performance.
Walking speed over 10 meters is reported in meters/second.
Measured: Baseline to end of follow-up (day 135)
Multidimensional Fatigue Inventory (MFI-20)
The MFI-20 assesses fatigue across five dimensions using 20 items. The total score ranges from 20 to 100, with higher scores indicating greater fatigue.
Measured: Baseline to end of follow-up (day 135)
Fatigue Severity Scale (FSS)
The FSS assesses the impact of fatigue on daily functioning. It contains nine items scored from 1 to 7. The mean score is calculated, with higher scores indicating greater fatigue severity.
Measured: Baseline to end of follow-up (day 135)
Stroke Impact Scale (SIS 3.0)
The SIS 3.0 assesses the impact of stroke on health and daily functioning across multiple domains. Domain scores range from 0 to 100, with higher scores indicating better functioning or fewer limitations.
Measured: Baseline to end of follow-up (day 135)
Five-level EuroQol five-dimension questionnaire (EQ-5D-5L)
The EQ-5D-5L assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a health utility index using an appropriate value set.
Measured: Baseline and end of follow-up (day 135)
Patient Global Impression of Change (PGIC)
The PGIC assesses the participant's overall perception of change in their condition. Scores range from 1 (very much improved) to 7 (very much worse), with 4 indicating no change.
Measured: End of treatment (day 90) and End of follow-up (day 135).
Adverse Events (AEs)
Number of participants experiencing at least one adverse event (AE). Adverse events will be recorded and assessed by severity, causality, and type.
Measured: Baseline and end of follow-up (day 135)
Serious Adverse Events (SAEs)
Number of participants experiencing at least one serious adverse event (SAE) during the study.
Measured: Baseline and end of follow-up (day 135)
Adverse Events of Special Interest (AESIs)
Number of participants experiencing at least one protocol-defined adverse event of special interest. Particular attention is given to psychiatric events and clinically relevant changes in mental status because of the known psychiatric risk profile of rimonabant.
Measured: Baseline and end of follow-up (day 135)
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) assesses depressive symptoms. Higher scores indicate greater depressive symptom severity. According to the protocol, a score ≥20 triggers clinical evaluation by the investigator.
Measured: Baseline and end of follow-up (day 135)
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression symptoms. Higher scores indicate greater symptom severity. According to the protocol, a score ≥11 on either subscale (anxiety or depression) triggers clinical evaluation by the investigator.
Measured: Baseline and end of follow-up (day 135)
The Visual Analogue Scale for Pain (VAS-P)
Assesses the participant's subjective perception of pain intensity. Changes from baseline will be used to identify clinically significant changes in pain during treatment and follow-up.
Measured: Baseline and end of follow-up (day 135)
Spasticity Assessed by Modified Ashworth Scale (MAS)
The MAS assesses resistance to passive movement as a measure of muscle spasticity. Scores range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), including an intermediate category of 1+. Higher scores indicate greater spasticity.
Measured: Baseline and end of follow-up (day 135)
Penn Spasm Frequency Scale (PSFS)
The PSFS assesses muscle spasm frequency. Scores range from 0 (no spasms) to 4 (spasms occurring more than ten times per hour). Higher scores indicate more frequent spasms.
Measured: Baseline and end of follow-up (day 135)
Number of Falls
Mean number of falls during the previous 30 days, based on weekly records in the participant diary and collected at each follow-up visit.
Measured: Baseline and end of follow-up (day 135)
Daily Standing Activity
Mean percentage of daily time spent standing during the previous 30 days, based on daily records in the participant diary and collected at each follow-up visit to provide contextual information when evaluating changes in the number of falls.
Measured: Baseline and end of follow-up (day 135)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinfatin S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913763
- Sponsor's protocol ID
- RIMOSTROKE-1
- Other IDs
- 2025-521693-33-00, 2025
- Acronym
- RIMOSTROKE-1
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a CB1 Receptor Antagonist/Inverse Agonist (Rimonabant) on Walking Ability in Patients in the Chronic Phase of Stroke (RIMOSTROKE-1)
- ClinicalTrials.gov ID
- NCT07913763
- Acronym / sponsor ID
- RIMOSTROKE-1 / RIMOSTROKE-1
- Conditions
- Chronic Stroke
- Keywords
- Rimonabant, CB1 receptor antagonist, Stroke rehabilitation, Motor recovery, Six-Minute Walk Test, Chronic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sinfatin S.LIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Nov 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 mail goal of this clinical trial is assess the effect of rimonabant in walking ability in people who experienced a stroke at least 12 months before enrollment.
It will include 80 adults aged 18 to 75 years that will receive either rimonabant (5 mg) or placebo (a look-alike tablet that contains no drug) once daily for 90 days. Neither the participants nor the investigators will know which treatment is being given.
The study will also help to learn about the safety of rimonabant.
Detailed description
Stroke is a major cause of long-term disability, and many patients experience persistent walking impairments despite rehabilitation. These limitations can significantly affect independence, mobility, and quality of life.
The endocannabinoid system, particularly the cannabinoid type 1 (CB1) receptor, is involved in the regulation of neuronal activity and motor function. Rimonabant is a selective CB1 receptor antagonist/inverse agonist that has demonstrated effects on corticospinal excitability and motor performance in previous preclinical and clinical research. Findings from studies involving patients with incomplete spinal cord injury suggest that low doses of rimonabant may have potential benefits for motor function.
Based on this evidence, RIMOSTROKE-1 aims to investigate whether treatment with low-dose rimonabant can improve walking ability in patients with chronic stroke.
RIMOSTROKE-1 is a randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of rimonabant 5 mg administered orally once daily compared with placebo. Participants will receive treatment for 90 days, followed by a 30-day follow-up period.
The primary objective is to evaluate the effect of rimonabant on walking capacity, measured by the percentage change in distance covered during the Six-Minute Walk Test (6MWT) from baseline to Day 90.
The study will also evaluate additional measures of motor function and safety, including the occurrence of adverse events and psychiatric safety assessments.
This study seeks to determine whether low-dose CB1 receptor modulation could represent a potential therapeutic approach to improving walking ability in patients with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimonabant 5 mg | Experimental | Drug: RimonabantParticipants randomized to receive rimonabant 5 mg. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to receive matching placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75 years.
- More than 12 months since diagnosis of stroke (chronic phase).
- Modified Rankin Scale score between 2 and 4.
- Ability to walk at least 5 meters with or without assistance.
- Capacity to provide written informed consent.
Key exclusion criteria (13 listed)
- High risk of suicide as assessed by the C-SSRS scale.
- History of severe psychiatric disorders, major depression or prior suicide attempts.
- Treatment with anticoagulants or strong CYP3A4 inhibitors or inducers (inhibitors such as ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, or nefazodone, and inducers such as rifampicin, phenytoin, phenobarbital, carbamazepine, or St. John's Wort).
- Body Mass Index (BMI) > 40 kg/m².
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| RimonabantRimonabant 5 mg administered orally as one orally disintegrating tablet (ODT) once daily for 90 consecutive days. | Drug | Rimonabant 5 mg |
| PlaceboParticipants will receive one matching placebo orally disintegrating tablet (ODT) once daily for 90 consecutive days. The placebo contains no rimonabant. | Drug | Placebo |
Primary outcome
Six-Minute Walk Test (6MWT)
Time frame: Baseline to end of follow-up (day 135)
The 6MWT assesses walking capacity by measuring the distance walked in six minutes, expressed in meters. The primary endpoint is the percentage change in walking distance from baseline to the end of follow-up on day 135. Greater distances indicate better walking capacity.
19 secondary outcomes
Six-Minute Walk Test (6MWT) -EOT
Time frame: Baseline to end of treatment (day 90)
Borg CR10 Scale
Time frame: Baseline to end of follow-up (day 135)
6MWT Clinically Relevant Improvement
Time frame: Baseline to end of follow-up (day 135)
Ten-Meter Walk Test (10MWT)
Time frame: Baseline to end of follow-up (day 135)
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Baseline to end of follow-up (day 135)
Fatigue Severity Scale (FSS)
Time frame: Baseline to end of follow-up (day 135)
Stroke Impact Scale (SIS 3.0)
Time frame: Baseline to end of follow-up (day 135)
Five-level EuroQol five-dimension questionnaire (EQ-5D-5L)
Time frame: Baseline and end of follow-up (day 135)
Patient Global Impression of Change (PGIC)
Time frame: End of treatment (day 90) and End of follow-up (day 135).
Adverse Events (AEs)
Time frame: Baseline and end of follow-up (day 135)
Serious Adverse Events (SAEs)
Time frame: Baseline and end of follow-up (day 135)
Adverse Events of Special Interest (AESIs)
Time frame: Baseline and end of follow-up (day 135)
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline and end of follow-up (day 135)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and end of follow-up (day 135)
The Visual Analogue Scale for Pain (VAS-P)
Time frame: Baseline and end of follow-up (day 135)
Spasticity Assessed by Modified Ashworth Scale (MAS)
Time frame: Baseline and end of follow-up (day 135)
Penn Spasm Frequency Scale (PSFS)
Time frame: Baseline and end of follow-up (day 135)
Number of Falls
Time frame: Baseline and end of follow-up (day 135)
Daily Standing Activity
Time frame: Baseline and end of follow-up (day 135)
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rimonabant in people with Chronic Stroke, run by Sinfatin S.L at 6 sites in Spain.
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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Antonio Oliviero, MD, PhD (+34 646330976, antonio.oliviero@sinfatin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (6MWT) (time frame: Baseline to end of follow-up (day 135)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.