Spinal Cord InjuryPhase 2RILUSCINCT02859792
Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition
A Phase 2 study testing Riluzole and Blood Samples in people with Spinal Cord Injury, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The study will be conducted in two steps: 1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel 2. Estimation of the probability of response associated to the MED. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Riluzole and Blood Samples
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2019to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic traumatic SCI defined as:
- At least a 12-month history of:
- C4-T12 traumatic SCI
- Complete and incomplete ( AIS A,B,C,D)
- With Spasticity (5>MAS>1 on at least adductor muscles and/or triceps surae muscles and NRS ≥ 4)
- Male or Female
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- Aged 18 to 65 years at the time of screening
- Judged by site investigator to be able to comply with evaluations at baseline and throughout the study
- Last injection of BTX-A in striated muscle more than 3 months ago and patients must have returned to their level of spasticity before BTX-A injection
- Last intrathecal (IT) injection of baclofen or per os administration of any myorelaxant should be more than 14 days ago (Step 1)
- The dose of myorelaxant or Baclofen should be stable for ≥ 30 days prior to screening and kept at stable daily dose until the end of the protocol (Step 2).
- Stable on all other chronic medications for ≥ 30 days prior to screening, including analgesics
- Stable on rehabilitation (methods and frequency) for ≥ 15 days prior to screening
- Written informed consent provided by subject
Who cannot join
- Spinal cord injury of less than 12 months,
- Associated Brain lesion that might be the cause of spasticity,
- MAS≤1 or =5 on at least adductor muscles and/or triceps surae muscles or NRS < 4
- Presence of urinary infection, fever, pressure ulcer or other spasticity-aggravating factors.
- Presence of other significant neurological or mental disorder or other illness, which would preclude accurate evaluation,
- Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance,
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- Insufficient fluency in local language to complete neuropsychological, global and spasticity assessments
- Active liver disease or clinical jaundice
- Active malignancy or history of invasive malignancy within the last five years
- Neutropenia, liver enzymes (ALT/SGPT or AST/SGOT) 2 times the upper limit of normal (ULN) at screening visit, baseline elevations of several liver function tests (especially elevated bilirubin).
- AIDS or AIDS-related complex,
- The systolic blood pressure measurement is > 190 or < 85 mm Hg and/or the diastolic blood pressure measurement is > 105 or < 50 mm Hg at screening.
- The ECG is abnormal at screening and judged to be clinically significant by the site investigator. Particular attention will be given to any sign suggesting conduction disorders.
- Treatment with any investigational drugs or device within 60 days of screening
- Any myorelaxant medication including IT baclofen, taken by the subject in the last 14 days prior to screening (step 1)
- Not stable under IT baclofen or per os myorelaxant medication for at least 30 days prior screening (step 2)
- Not stable on all other chronic medications for ≥ 30 days prior to screening, including analgesics
- Injection of BTX-A in striated muscle less than 3 months ago
- Subject is currently using, and will continue to use for the next 14 days any of the following medications which are classified as Inhibitors of CYP 1A2 (e.g. diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) or Inducers of CYP 1A2 (e.g. rifampicin and omeprazole)
- Ongoing pregnancy or lactation. Women with childbearing potential not using any form of efficacious contraception.
- Known hypersensitivity to Riluzole
Trial locations and contacts
1 site in 1 country.
OLIVIER BLIN contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
OLIVIER BLIN, olivier.blin@ap-hm.fr
jean-michel VITON
About this study
Official title: Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition: Adaptive, Multicenter, Placebo-controlled, Randomised, Double Blind Trial in a Rare Disorder
The study will be conducted in two steps:
- Determination of the Minimal Effective Dose (MED) among the four doses of the panel
- Estimation of the probability of response associated to the MED.
Each step has a main objective:
Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI
Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity vs placebo, in patients with chronic SCI.
- Conditions
- Spinal Cord Injury
- Being tested
- Riluzole, Placebo, Blood Samples
- 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.
RiluzoleDrug
Riluzole capsules (25 or 50 mg) will be administered in the four dose level groups (i.e. 25 mg bid; 50 mg bid; 75 mg bid; 100 mg bid).
PlaceboDrug
placebo capsules 25 or 50 mg
Blood SamplesBiological
v1;v2;v3;v4
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Biological: Blood Samples |
| Experimental | Experimental | Not described Receives: Drug: Riluzole; Biological: Blood Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Minimum Effective Dose (MED) of Riluzole
Blood Sample
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start27 May 2019
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hopitaux De MarseilleOLIVIER BLIN, Principal investigator, Assistance Publique Hopitaux De MarseilleJEAN MICHEL VITON, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859792
- Sponsor's protocol ID
- 2016-000901-35
- Other IDs
- 2016-02, 2016
- Acronym
- RILUSCI
- Status last verified
- Apr 2023
- First submitted
- 2 Aug 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cotinat M, Boquet I, Ursino M, Brocard C, Jouve E, Alberti C, Bensoussan L, Viton JM, Brocard F, Blin O. Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase ib/iib adaptive multicenter randomized controlled RILUSCI trial. PLoS One. 2023 Jan 20;18(1):e0276892. doi: 10.1371/journal.pone.0276892. eCollection 2023.
PubMed 36662869
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition: Adaptive, Multicenter, Placebo-controlled, Randomised, Double Blind Trial in a Rare Disorder
- ClinicalTrials.gov ID
- NCT02859792
- Acronym / sponsor ID
- RILUSCI / 2016-000901-35
- Conditions
- Spinal Cord Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- 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 study will be conducted in two steps:
- Determination of the Minimal Effective Dose (MED) among the four doses of the panel
- Estimation of the probability of response associated to the MED.
Each step has a main objective:
Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI
Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity vs placebo, in patients with chronic SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Biological: Blood Samples |
| Experimental | Experimental | Drug: Riluzole, Biological: Blood Samples |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Chronic traumatic SCI defined as:
- Male or Female
- Aged 18 to 65 years at the time of screening
- Judged by site investigator to be able to comply with evaluations at baseline and throughout the study
- Last injection of BTX-A in striated muscle more than 3 months ago and patients must have returned to their level of spasticity before BTX-A injection
Key exclusion criteria (21 listed)
- Spinal cord injury of less than 12 months,
- Associated Brain lesion that might be the cause of spasticity,
- MAS≤1 or =5 on at least adductor muscles and/or triceps surae muscles or NRS < 4
- Presence of urinary infection, fever, pressure ulcer or other spasticity-aggravating factors.
- Presence of other significant neurological or mental disorder or other illness, which would preclude accurate evaluation,
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 |
|---|---|---|
| RiluzoleRiluzole capsules (25 or 50 mg) will be administered in the four dose level groups (i.e. 25 mg bid; 50 mg bid; 75 mg bid; 100 mg bid). | Drug | Experimental |
| Placeboplacebo capsules 25 or 50 mg | Drug | Placebo |
| Blood Samplesv1;v2;v3;v4 | Biological | Experimental, Placebo |
Primary outcome
the Minimum Effective Dose (MED) of Riluzole
Time frame: 2 Months
Blood Sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 36662869Cotinat M, Boquet I, Ursino M, Brocard C, Jouve E, Alberti C, Bensoussan L, Viton JM, Brocard F, Blin O. Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase ib/iib adaptive multicenter randomized controlled RILUSCI trial. PLoS One. 2023 Jan 20;18(1):e0276892. doi: 10.1371/journal.pone.0276892. eCollection 2023.
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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.
OLIVIER BLIN contact
Catherine GEINDRE study director
Assistance Publique Hopitaux De Marseille
OLIVIER BLIN principal investigator
Assistance Publique Hopitaux De Marseille
JEAN MICHEL VITON principal investigator
Assistance Publique Hopitaux De Marseille
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 Riluzole and Blood Samples in people with Spinal Cord Injury, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 14 inclusion and 21 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 Apr 2023. 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 France. 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 OLIVIER BLIN (olivier.blin@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Minimum Effective Dose (MED) of Riluzole (time frame: 2 Months). 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 NCT02859792, which also lists 1 linked publication.
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 Apr 2023.