Spinal Cord InjuriesPhase 2RIMOFATSCI-2NCT05622994
Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
A Phase 2 study testing Rimonabant in people with Spinal Cord Injuries, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
Trial summary
This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Rimonabant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2022to Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 >18 yo and <75yo
- Non progressive spinal cord injury
- Incomplete lesion (AIS C or D)
- Neurological level between C4 and L1
- Chronic stage (>1 year since injury)
- Preserved walking ability for at least 5 m (aid allowed)
- Capability to provide informed consent
- For fertile women, possibility to use anti conceptive methods
Who cannot join
- Age <18 yo or >75
- AIS A, B or E
- Neurological level above C4 or below L1
- Subacute stage (<1 year since injury)
- Preserved walking ability for less than 5 m (aid allowed)
- Pregnancy or breast feeding
Show all 12Show fewer
- For fertile women, impossibility to use anti conceptive methods
- anticoagulant treatment
- Hypothyroidism
- Severe bone, kidney or liver disfunction
- Impossibility to reach the hospital
- Impossibility to rovide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos
This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.
Read the detailed description
This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period.
Main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of Rimonabant in a specific population (incomplete spinal cord injury).
- Conditions
- Spinal Cord Injuries
- Being tested
- Rimonabant
- Keywords
- walking abilities, Rimonabant, Endurance, Incomplete SCI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Also called Placebo
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Active comparator | Rimonabant 5mg Receives: Drug: Rimonabant |
| Placebo | Placebo comparator | Placebo Receives: Drug: Rimonabant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (Safety)
Number of AE
Measured: 120 days
Biochemical and urine analysis (safety)
Number of participants with clinically significant abnormal laboratory tests results
Measured: 120 days
ECG (safety)
Number of participants with clinically significant abnormal ECG readings
Measured: 120 days
Hospital Anxiety and Depression Scale (HAD) (safety
Range 0-21(higher values more severe)
Measured: 120 days
Modified Ashworth Scale (safety)
Range 0-4 (higher values more severe)
Measured: 90 days
Penn Scale (safety)
Range 0-4 (higher values more severe)
Measured: 90 days
Pain numeric rating scale (safety)
Range 0-10 (higher values more severe)
Measured: 90 days
Questionnaire of falls (safety)
Number of falls
Measured: 120 days
6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
Measured: 90 days
Secondary outcomes (8)
10 m test (efficacy)
Time to walk 10 m (no stops are allowed)
Measured: 90 days
Borg Scale (efficacy)
Borg Scale punctuation after 6 min waking test. Range 0-10.
Measured: 90 days
Motor Score (efficacy)
Motor Score (ISNCSCI). Range 0-20 (higher values less severe)
Measured: 90 days
Fatigue Severity Scale (FSS) (Efficacy)
FSS puntuación. Range 0-7 (higher values more severe)
Measured: 90 days
Patient global impression of changes (PGIC) (efficacy)
PGIG score. Range 1-7 (higher values indicate worsening)
Measured: 90 days
European Quality of Life -5 Dimensions (EQ-5D) (efficacy)
EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 3 problem levels corresponding to patient response choices (higher values worst). A quality-of-life score is obtained according to the answers to the questionnaires (algorithm to calculate the score in euroqol.org). The maximum score is 1 that indicates excellent quality of life (range for Spanish version 0.5-1).
Measured: 90 days
Health state visual analogically scale (efficacy)
Range 0-100 mm (higher values indicate higher health state )
Measured: 90 days
Spinal Cord Independence Measures, SCIM (efficacy)
Range 0-100 (higher values indicate higher independence )
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Model description
- Placebo controlled parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo
- Investigators
- Antonio Oliviero, MD, PhD, Principal investigator, Hospital Nacional de Parapléjicos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622994
- Sponsor's protocol ID
- FHNP-CT003
- Acronym
- RIMOFATSCI-2
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos
- ClinicalTrials.gov ID
- NCT05622994
- Acronym / sponsor ID
- RIMOFATSCI-2 / FHNP-CT003
- Conditions
- Spinal Cord Injuries
- Keywords
- walking abilities, Rimonabant, Endurance, Incomplete SCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Nacional de Parapléjicos de ToledoUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 21 Nov 2022 (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.
This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.
Detailed description
This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period.
Main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of Rimonabant in a specific population (incomplete spinal cord injury).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled parallel design
| Arm | Type | Receives |
|---|---|---|
| Rimonabant | Active comparator | Drug: RimonabantRimonabant 5mg |
| Placebo | Placebo comparator | Drug: RimonabantPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 yo and <75yo
- Non progressive spinal cord injury
- Incomplete lesion (AIS C or D)
- Neurological level between C4 and L1
- Chronic stage (>1 year since injury)
Key exclusion criteria (12 listed)
- Age <18 yo or >75
- AIS A, B or E
- Neurological level above C4 or below L1
- Subacute stage (<1 year since injury)
- Preserved walking ability for less than 5 m (aid allowed)
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 |
|---|---|---|
| RimonabantAlso: PlaceboRimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration. | Drug | Placebo, Rimonabant |
Primary outcome
Adverse Events (Safety)
Time frame: 120 days
Number of AE
Biochemical and urine analysis (safety)
Time frame: 120 days
Number of participants with clinically significant abnormal laboratory tests results
ECG (safety)
Time frame: 120 days
Number of participants with clinically significant abnormal ECG readings
Hospital Anxiety and Depression Scale (HAD) (safety
Time frame: 120 days
Range 0-21(higher values more severe)
Modified Ashworth Scale (safety)
Time frame: 90 days
Range 0-4 (higher values more severe)
Penn Scale (safety)
Time frame: 90 days
Range 0-4 (higher values more severe)
Pain numeric rating scale (safety)
Time frame: 90 days
Range 0-10 (higher values more severe)
Questionnaire of falls (safety)
Time frame: 120 days
Number of falls
6 min walking test (efficacy)
Time frame: 90 days
6 min walking test (meters and number of stops are reported)
8 secondary outcomes
10 m test (efficacy)
Time frame: 90 days
Borg Scale (efficacy)
Time frame: 90 days
Motor Score (efficacy)
Time frame: 90 days
Fatigue Severity Scale (FSS) (Efficacy)
Time frame: 90 days
Patient global impression of changes (PGIC) (efficacy)
Time frame: 90 days
European Quality of Life -5 Dimensions (EQ-5D) (efficacy)
Time frame: 90 days
Health state visual analogically scale (efficacy)
Time frame: 90 days
Spinal Cord Independence Measures, SCIM (efficacy)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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. This study is not recruiting at the moment.
Antonio Oliviero, MD, PhD principal investigator
Hospital Nacional de Parapléjicos
1 site 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 Spinal Cord Injuries, run by Hospital Nacional de Parapléjicos de Toledo at 1 site 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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 Nov 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Oliviero, MD, PhD (+34925247700 ext. 47120, antonioo@sescam.jccm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (Safety) (time frame: 120 days). The study lists 9 primary outcomes in all. 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 21 Nov 2022.