Spinal Cord InjuriesPhase 1/2RIMOFATSCI-1NCT05398913
Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
A Phase 1/2 study testing Rimonabant in people with Spinal Cord Injuries, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
Trial summary
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- 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
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 12 May 2021to 7 Jun 2022
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic spinal cord injury
- Incomplete lesion (AIS D)
- Neurological level between C4 and L1
- Chronic stage (>1 year since injury)
- Preserved walking ability for at least 5 m (aid allowed)
- Psychiatric assessment to exclude individuals with high suicide risk
- Capability to provide informed consent
- For fertile women, possibility to use anti conceptive methods
Who cannot join
- Non traumatic spinal cord injury
- AIS A, B, C 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
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- For fertile women, impossibility to use anti conceptive methods
- Anticoagulant treatment
- Hypothyroidism
- Severe kidney or liver dysfunction
- Severe depression
- Fatigue treatment in the last 6 months
- Impossibility to reach the Hospital
- Impossibility to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.
Read the detailed description
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.
Main goal is to test safety of Rimonabant in a specific population (incomplete spinal cord injury).
- Conditions
- Spinal Cord Injuries
- Being tested
- Rimonabant
- Keywords
- Spinal cord injury, Walking endurance, Incomplete SCI, Traumatic
- 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
Rimonabant
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two pills of placebo will be administered for 5 consecutive days, once per day. Receives: Drug: Rimonabant |
| Rimonabant 2.5 mg | Active comparator | One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. Receives: Drug: Rimonabant |
| Rimonabant 5 mg | Active comparator | Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. 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: 150 days
6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
Measured: 5 days
Biochemical and urine analysis (safety)
Number of participants with clinically significant abnormal laboratory tests results
Measured: 8 days
ECG (safety)
Number of participants with clinically significant abnormal ECG readings
Measured: 8 days
Beck Depression Inventory (BDI) (safety)
Range 0-63 (higher values more severe)
Measured: 15 days
Hospital Anxiety and Depression Scale (HAD) (safety)
Range 0-21(higher values more severe)
Measured: 15 days
Modified Ashworth Scale (safety)
Range 0-4 (higher values more severe)
Measured: 15 days
Penn Scale (safety)
Range 0-4 (higher values more severe)
Measured: 15 days
Secondary outcomes (10)
10 m test (efficacy)
Time to walk 10 m (no stops are allowed)
Measured: 5 days and 15 days
6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
Measured: 15 days
Borg Scale (efficacy)
Borg Scale punctuation after 6 min waking test. Range 0-10.
Measured: 5 days and 15 days
WISCI II (efficacy)
Range 0-20 (higher values less severe)
Measured: 5 and 15 days
Motor Score (efficacy)
Motor Score (ISNCSCI). Range 0-20 (higher values less severe)
Measured: 8 days
Fatigue Severity Scale (FSS) (Efficacy)
FSS puntuación. Range 0-7 (higher values more severe)
Measured: 5 and 15 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: 8 days
Patient global impression of changes (PGIC) (efficacy)
PGIG score. Range 1-7 (higher values indicate worsening)
Measured: 5 and 15 days
Pain numeric rating scale
Range 0-10 (higher values more severe)
Measured: 8 days
Health state visual analogically scale
Range 0-100 mm (higher values indicate higher health state )
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start12 May 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover study with three arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
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
- NCT05398913
- Sponsor's protocol ID
- FHNP-CT002
- Acronym
- RIMOFATSCI-1
- Status last verified
- Nov 2022
- First submitted
- 23 May 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT05398913
- Acronym / sponsor ID
- RIMOFATSCI-1 / FHNP-CT002
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injury, Walking endurance, Incomplete SCI, Traumatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hospital Nacional de Parapléjicos de ToledoUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 1 Jun 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.
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.
Detailed description
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.
Main goal is to test safety of Rimonabant in a specific population (incomplete spinal cord injury).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized crossover study with three arms
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: RimonabantTwo pills of placebo will be administered for 5 consecutive days, once per day. |
| Rimonabant 2.5 mg | Active comparator | Drug: RimonabantOne pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. |
| Rimonabant 5 mg | Active comparator | Drug: RimonabantTwo pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Traumatic spinal cord injury
- Incomplete lesion (AIS D)
- Neurological level between C4 and L1
- Chronic stage (>1 year since injury)
- Preserved walking ability for at least 5 m (aid allowed)
Key exclusion criteria (14 listed)
- Non traumatic spinal cord injury
- AIS A, B, C 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 |
|---|---|---|
| RimonabantRimonabant | Drug | Placebo, Rimonabant 2.5 mg, Rimonabant 5 mg |
Primary outcome
Adverse events (safety)
Time frame: 150 days
number of AE
6 min walking test (efficacy)
Time frame: 5 days
6 min walking test (meters and number of stops are reported)
Biochemical and urine analysis (safety)
Time frame: 8 days
Number of participants with clinically significant abnormal laboratory tests results
ECG (safety)
Time frame: 8 days
Number of participants with clinically significant abnormal ECG readings
Beck Depression Inventory (BDI) (safety)
Time frame: 15 days
Range 0-63 (higher values more severe)
Hospital Anxiety and Depression Scale (HAD) (safety)
Time frame: 15 days
Range 0-21(higher values more severe)
Modified Ashworth Scale (safety)
Time frame: 15 days
Range 0-4 (higher values more severe)
Penn Scale (safety)
Time frame: 15 days
Range 0-4 (higher values more severe)
10 secondary outcomes
10 m test (efficacy)
Time frame: 5 days and 15 days
6 min walking test (efficacy)
Time frame: 15 days
Borg Scale (efficacy)
Time frame: 5 days and 15 days
WISCI II (efficacy)
Time frame: 5 and 15 days
Motor Score (efficacy)
Time frame: 8 days
Fatigue Severity Scale (FSS) (Efficacy)
Time frame: 5 and 15 days
European Quality of Life -5 Dimensions (EQ-5D) (efficacy)
Time frame: 8 days
Patient global impression of changes (PGIC) (efficacy)
Time frame: 5 and 15 days
Pain numeric rating scale
Time frame: 8 days
Health state visual analogically scale
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No. Upon reasonable request
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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. 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 1/2 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 14 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: finished, as of the sponsor's last update on 15 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (safety) (time frame: 150 days). The study lists 8 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 15 Nov 2022.