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New treatment option for Stroke
Official title The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
ClinicalTrials.gov ID: NCT06446960
What this study is testing
What is Lidocaine 20mg/ml?
Lidocaine 20mg/ml is an investigational medicine, given as an once-daily, being studied as a potential treatment for stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood. Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord and/or brain nociceptive systems.
- Phase 3: a large, late-stage study
- Time commitment: about 2 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged 18 years and over with no maximum age (blocks are generally very well tolerated in the very elderly)
- Pain in the upper or lower limb distal enough to be completely covered by a peripheral nerve block
- Chronic pain for at least 6 months
- Ischaemic or haemorrhagic stroke for at least 6 months documented clinically and by appropriate imaging (MRI)
- Post-stroke central neuropathic pain defined as pain occurring in the aftermath of stroke meeting the criteria for probable or defined neuropathic...
You likely can't join if
- Inability or unwillingness to sign an informed consent
- Person subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
- Patients with ongoing psychiatric pathology (major depression, psychosis) or cognitive disorders that prevent a good understanding of the protocol...
- Pain that is too widespread in one hemicycle or limb and cannot be adequately covered by blocks
- Ongoing drug or substance abuse
- Language (aphasia) or comprehension disorders, illiteracy
See the full eligibility criteria
- Patients aged 18 years and over with no maximum age (blocks are generally very well tolerated in the very elderly)
- Pain in the upper or lower limb distal enough to be completely covered by a peripheral nerve block
- Chronic pain for at least 6 months
- Ischaemic or haemorrhagic stroke for at least 6 months documented clinically and by appropriate imaging (MRI)
- Post-stroke central neuropathic pain defined as pain occurring in the aftermath of stroke meeting the criteria for probable or defined neuropathic pain according to the NeuPSIG algorithm and with a DN4 screening...
- Spontaneous pain intensity greater than or equal to 4 out of 10 on an 11-point numerical scale (EN) at inclusion and randomisation (i.e. just before each block)
- Patients affiliated to a social security scheme or beneficiaries of such a scheme
- Stable oral analgesic pharmacological treatment for at least 2 weeks prior to inclusion
- Acceptance and signing of the informed consent
- Inability or unwillingness to sign an informed consent
- Person subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
- Patients with ongoing psychiatric pathology (major depression, psychosis) or cognitive disorders that prevent a good understanding of the protocol and questionnaires
- Pain that is too widespread in one hemicycle or limb and cannot be adequately covered by blocks
- Ongoing drug or substance abuse
- Language (aphasia) or comprehension disorders, illiteracy
- Moderate to severe renal or hepatic impairment
- Contraindication to local anaesthetics for use in perineural blocks (infection or acute inflammation in the injection area, known allergy).
- Pregnancy or breastfeeding
- Known hypersensitivity to lidocaine, levobupivacaine, amide-linked local anaesthetics or to any of the excipients contained in the specialities used in the study.
- Patients with recurrent porphyria or severe hypotension contraindicating treatment with lidocaine and/or levobupivacaine
- Current treatment with antiarrhythmic drugs causing torsades de pointes (amiodarone, disopyramide, quinidinics, sotalol...) or with antiarrhythmic drugs with local anaesthetic activity (mexiletine or class III...
- Too little pain at the time of the blocks (\< 4 out of 10)
- Need to modify analgesic pharmacological treatment at the beginning or during the study
The study team makes the final eligibility decision.
Where it's taking place
- Boulogne-Billancourt, France
- Garches, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulogne-Billancourt, France; Garches, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.