A Phase 2 interventional study of Rimonabant and Placebo in Chronic Stroke, sponsored by Sinfatin S.L. Not yet recruiting at 6 sites in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Sinfatin S.L · Phase 2, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 80 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Sinfatin S.L is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to receive rimonabant 5 mg.
Drug: Rimonabant
Participants randomized to receive matching placebo.
Drug: Placebo
Rimonabant 5 mg administered orally as one orally disintegrating tablet (ODT) once daily for 90 consecutive days.
Participants will receive one matching placebo orally disintegrating tablet (ODT) once daily for 90 consecutive days. The placebo contains no rimonabant.
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.
Time frame: Baseline to end of follow-up (day 135)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and end of follow-up (day 135)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2028, 14 months later.
Of 133 phase 2 interventional studies under Stroke, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rimonabant
Sinfatin S.L