NeuralgiaPhase 3KEKU1NCT03513822
Ketamine's Efficiency in the Treatment of Chronic Pain: Kynurenin Pathway
A Phase 3 study testing Ketamine 10 MG/ML and Midazolam 1 MG/ML in people with Neuralgia and Chronic Pain, run by Redar at 1 site in France.
Trial summary
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Chronic Pain, Inflammation
- What is being tested?
- Ketamine 10 MG/ML and Midazolam 1 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2018to Nov 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults speaking and understanding French
- presenting chronic neuropathic pain as defined by IASP
- Painful intensity> or = to 6/10 during the week preceding the inclusion - Medullary lesion, whatever the origin (traumatic, degenerative, tumoral, postoperative), responsible for paraplegia in a chronic state.
- Able to give informed consent, after clear, fair and appropriate information
- Having given their consent by a written consent signature.
Who cannot join
- Hypersensitivity to ketamine or any of its components
- Participation in another interventional trial, or participation in another trial.
- Patient unable to give consent.
- Pregnancy or breastfeeding
- Refusal to sign the consent
- Cardiovascular diseases associated in particular with disorders of rhythm and severe cardiac insufficiency, coronary insufficiency, discovered on examination, on ECG or by biological balance or known. - unstabilized HTA> 180/100 mmHg
- Severe hepatic and / or renal hepatic insufficiency.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Raymond Poincaré Hospital
Garches, Hauts De Seine, 92380
Cyril QUEMENEUR, Resident, 0033681193981, c.quemeneur@gmx.com
Valeria Martinez, MD, PhD, 0033601819222, valeria.martinez@aphp.fr
About this study
Official title: Ketamine's Efficiency in the Treatment of Chronic Pain With an Added Inflammatory Component Exploring the Kynurenin Pathway. A Randomized, Double Blind, Placebo-controlled Trial
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway.
Study design: Interventional randomized placebo-controlled clinical trial.
Main goals:
- To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
- Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
Read the detailed description
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway.
Study design: Interventional randomized placebo-controlled clinical trial.
Main goals:
- To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
- Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
Population Adult, medullary injured (BM), with chronic neuropathic pain (DN). 4 groups: BM with DN with bedsore Ketamine Group versus Placebo Group BM with DN without bedsore group Ketamine versus Placebo Group
Intervention Ketamine infusion 1 mg / kg IVSE over two hours versus Nacl perfusion 0.9%
 Primary judgment criterion Decrease by more than 30% the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points between H0 and H4. Comparison of groups two by two.
Secondary judgment criterions:
NPSI score (Neuropathic pain symptom inventory) at H1, H4, D1, D4, J7 Sub score of NPSI; H1, H4, J1, J4, J7 Depression Scale HADS (Hospital Anxiety Depression Scale) J0, J1, J7 Plasma serotonin (5-HT) kynurenine (KYN), indoleamine 2,3-dioxygenase 1 (IDO1) activity (KYN / TRP ratio), kynurenic acid ( KA) and quinolinic acid (QA), as well as 3 proinflammatory cytokines IL-1β, IL-6, and TNF-α before perfusion and H4 perfusion.
In parallel blood samples will be collected to study the activation of the kynurenine pathway in response to inflammation due to a pressure ulcer.
- Conditions
- Neuralgia, Chronic Pain, Inflammation
- Being tested
- Ketamine 10 MG/ML, Placebos, Midazolam 1 MG/ML
- Keywords
- KETAMINE, CHRONIC PAIN, NEUROPATHIC PAIN, KYNURENINE, KYNURENINE PATHWAY, BEDSORES, ANTI-INFLAMMATORY, ULCER PRESSURE
- Medical subject headings
- Neuralgia, Chronic Pain, Inflammation, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 10 MG/MLDrug
Ketamine infusion 1mg/kg with electric syringe during 2 hours.
PlacebosDrug
Also called Sodium chloride infusion
Sodium chloride infusion with the same rate, electric syringe during 2 hours.
Midazolam 1 MG/MLDrug
Bolus of Midazolam 1mg before each perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Chronic neuropathic pain and bedsore Ketamine group | Active comparator | Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and ulcer pressure (inflammation factor).
Midazolam 1mg before infusion. KETAMINE INFUSION IVSE 1mg/kg during 2 hours (0,5mg/kg/h). Preparation of 100mg in fifty cc, syringe with 2mg/ml. Rate of administration: Speed = Patient weight divided by four.
Maximum 100mg. One and only perfusion. Receives: Drug: Ketamine 10 MG/ML; Drug: Midazolam 1 MG/ML |
| Chronic neuropathic pain and bedsore Placebo group | Placebo comparator | Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and ulcer pressure (inflammation factor).
Midazolam 1mg before infusion. Sodium chloride infusion IVSE during 2 hours. Rate of administration : Speed = patient weight divided by four.
One and only perfusion. Receives: Drug: Placebos; Drug: Midazolam 1 MG/ML |
| Chronic neuropathic pain without bedsore Ketamine group | Active comparator | Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and no ulcer pressure (no inflammation factor).
Midazolam 1mg before infusion. KETAMINE INFUSION IVSE 1mg/kg during 2 hours (0,5mg/kg/h). Preparation of 100mg in fifty cc, syringe with 2mg/ml. Rate of administration: Speed = Patient weight divided by four.
Maximum 100mg. One and only perfusion. Receives: Drug: Ketamine 10 MG/ML; Drug: Midazolam 1 MG/ML |
| Chronic neuropathic pain without bedsore Placebo group | Placebo comparator | Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and no ulcer pressure (no inflammation factor).
Midazolam 1mg before infusion. Sodium chloride infusion IVSE during 2 hours. Rate of administration : Speed = patient weight divided by four.
One and only perfusion. Receives: Drug: Placebos; Drug: Midazolam 1 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale decrease between H0 and H4.
Numeric pain rating scale is a scale from 0 to 10. 0 is no pain, 10 is the worst pain we could imagine. The first outcome is decreasing the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points at H4. Comparison of groups two by two.
Measured: 4 hours after the end of infusion
Secondary outcomes (17)
Paraclinical: Kynurenine pathway levels : SEROTONIN
Levels of SEROTONIN (millimoles/liter)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : KYNURENINE
Levels of KYNURENINE (millimoles/liter)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : IDO ACTIVITY
Levels of INDOLEAMINE DIOXYGENASE ACTIVITY (division Kynurenine/Tryptophane quote)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : KYNURENIC ACID
Levels of Kynurenic acid (millimoles/liter)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : QUINOLINIC ACID
Levels of Quinolinic acid (millimoles/liter)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : IL1
Levels of Interleukin 1 (picograms/milliliter)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : IL6
Levels of Interleukin 6 (picograms/milliliter)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels: TNF alpha
Levels of TNF alpha (picograms/milliliter)
Measured: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Clinical: Neuropathic pain symptom inventory
NPSI scoring: Neuropathic pain symptom inventory. A composite score composed by neuropathic pain components: Burning, Pressure, Squeezing, Electric shocks, Stabbing, Evoked by brushing, evoked by pressure, evoked by cold stimuli, pins and needles, tingling. Two questions about the time of pain for twenty four hours, and the numbers of crisis. Score from 0 to 100. 100 is the maximum.
Measured: Hour 0, Day 1, Day 4, Day 7
Clinical: Pain timeline
Timeline of self assessment on a simple numeric scale of the pain three times a day during a week. Numeric pain rating scale is a scale from 0 to 10. 0 is no pain, 10 is the worst pain we could imagine.
Measured: Seven days
Percentage overall improvement in pain over a week with self assessment
Self assessment of the global improvement in pain over the week after infusion
Measured: Between Hour 0 and Day 7
Clinical: Subscore of Neuropathic pain symptom inventory
Subscore on NPSI scoring: NEUROPATHIC PAIN SYMPTOM INVENTORY, subscore are burning from 0 to 10, pressing (deep) spontaneous pain from 0 to 10, paroxysmal pain from 0 to 10, evoked pain from 0 to 10, paresthesia or dysesthesia from 0 to 10 (0 is the minimal, 10 is the maximal value for each of the component).
Measured: Hour 0, Day 1, Day 4, Day 7
Clinical: Hospital anxiety and depression scale
Recording scoring on hospital anxiety and depression scale. HADS scale is a tool to detect anxiety and depressive disorders. It includes fourteen questions from 0 to 3 points each. Seven are related to anxiety. Seven are related to depressive mood. It permits to obtain 2 different scales with the maximum of each of 21.
Measured: Hour 0, Day 7.
Percentage overall improvement in mood over a week with self assessment
Self assessment of the global improvement of the mood over the week after infusion
Measured: Between Hour 0 and day 7
Clinical: Pain area on a body cartography
Evaluation of pain area on a body surface cartography
Measured: Hour 0, Day 1, Day 7.
Clinical: Ketamine adverse effects
Recording ketamine adverse effects during and right after the infusion
Measured: Hour 0 to hour 4
Paraclinical: Kynurenine pathway activation with ulcer pressure
Studying the levels of the kynurenine pathway elements between patients with inflammatory component (ulcer pressure) and without inflammatory component (without ulcer pressure)
Measured: Hour 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start16 Feb 2018
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (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 NeuralgiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional randomized placebo-controlled clinical trial. Adult, medullary injured (BM), with chronic neuropathic pain (DN). 4 groups: BM with DN with bedsore Ketamine Group versus Placebo Group BM with DN without bedsore group Ketamine versus Placebo Group Ketamine infusion 1 mg / kg IVSE over two hours versus Nacl perfusion 0.9%
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Redar
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Raymond Poincaré, Hopital Lariboisière, Institut National de la Santé Et de la Recherche Médicale, France, Fondation Apicil, Hospital Ambroise Paré Paris, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
- Responsible party
- Sponsor
- Investigators
- Didier Bouhassira, Md, PhD, Study chair, INSERM U987
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513822
- Sponsor's protocol ID
- REDAR
- Other IDs
- 2017-003930-10, protocole ph-03-2018, 2017
- Acronym
- KEKU1
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
PubMed 39428602
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine's Efficiency in the Treatment of Chronic Pain With an Added Inflammatory Component Exploring the Kynurenin Pathway. A Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03513822
- Acronym / sponsor ID
- KEKU1 / REDAR
- Conditions
- Neuralgia, Chronic Pain, Inflammation
- Keywords
- KETAMINE, CHRONIC PAIN, NEUROPATHIC PAIN, KYNURENINE, KYNURENINE PATHWAY, BEDSORES, ANTI-INFLAMMATORY, ULCER PRESSURE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- RedarUniversity, hospital or other
- Collaborators
- Hôpital Raymond Poincaré, Hopital Lariboisière, Institut National de la Santé Et de la Recherche Médicale, France, Fondation Apicil, Hospital Ambroise Paré Paris, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 May 2018 (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.
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway.
Study design: Interventional randomized placebo-controlled clinical trial.
Main goals:
- To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
- Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
Detailed description
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway.
Study design: Interventional randomized placebo-controlled clinical trial.
Main goals:
- To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
- Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
Population Adult, medullary injured (BM), with chronic neuropathic pain (DN). 4 groups: BM with DN with bedsore Ketamine Group versus Placebo Group BM with DN without bedsore group Ketamine versus Placebo Group
Intervention Ketamine infusion 1 mg / kg IVSE over two hours versus Nacl perfusion 0.9%
 Primary judgment criterion Decrease by more than 30% the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points between H0 and H4. Comparison of groups two by two.
Secondary judgment criterions:
NPSI score (Neuropathic pain symptom inventory) at H1, H4, D1, D4, J7 Sub score of NPSI; H1, H4, J1, J4, J7 Depression Scale HADS (Hospital Anxiety Depression Scale) J0, J1, J7 Plasma serotonin (5-HT) kynurenine (KYN), indoleamine 2,3-dioxygenase 1 (IDO1) activity (KYN / TRP ratio), kynurenic acid ( KA) and quinolinic acid (QA), as well as 3 proinflammatory cytokines IL-1β, IL-6, and TNF-α before perfusion and H4 perfusion.
In parallel blood samples will be collected to study the activation of the kynurenine pathway in response to inflammation due to a pressure ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Interventional randomized placebo-controlled clinical trial. Adult, medullary injured (BM), with chronic neuropathic pain (DN). 4 groups: BM with DN with bedsore Ketamine Group versus Placebo Group BM with DN without bedsore group Ketamine versus Placebo Group Ketamine infusion 1 mg / kg IVSE over two hours versus Nacl perfusion 0.9%
| Arm | Type | Receives |
|---|---|---|
| Chronic neuropathic pain and bedsore Ketamine group | Active comparator | Drug: Ketamine 10 MG/ML, Drug: Midazolam 1 MG/MLSpinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months). Patients medullary wounded with chronic pain and ulcer pressure (inflammation factor). Midazolam 1mg before infusion. KETAMINE INFUSION IVSE 1mg/kg during 2 hours (0,5mg/kg/h). Preparation of 100mg in fifty cc, syringe with 2mg/ml. Rate of administration: Speed = Patient weight divided by four. Maximum 100mg. One and only perfusion. |
| Chronic neuropathic pain and bedsore Placebo group | Placebo comparator | Drug: Placebos, Drug: Midazolam 1 MG/MLSpinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months). Patients medullary wounded with chronic pain and ulcer pressure (inflammation factor). Midazolam 1mg before infusion. Sodium chloride infusion IVSE during 2 hours. Rate of administration : Speed = patient weight divided by four. One and only perfusion. |
| Chronic neuropathic pain without bedsore Ketamine group | Active comparator | Drug: Ketamine 10 MG/ML, Drug: Midazolam 1 MG/MLSpinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months). Patients medullary wounded with chronic pain and no ulcer pressure (no inflammation factor). Midazolam 1mg before infusion. KETAMINE INFUSION IVSE 1mg/kg during 2 hours (0,5mg/kg/h). Preparation of 100mg in fifty cc, syringe with 2mg/ml. Rate of administration: Speed = Patient weight divided by four. Maximum 100mg. One and only perfusion. |
| Chronic neuropathic pain without bedsore Placebo group | Placebo comparator | Drug: Placebos, Drug: Midazolam 1 MG/MLSpinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months). Patients medullary wounded with chronic pain and no ulcer pressure (no inflammation factor). Midazolam 1mg before infusion. Sodium chloride infusion IVSE during 2 hours. Rate of administration : Speed = patient weight divided by four. One and only perfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults speaking and understanding French
- presenting chronic neuropathic pain as defined by IASP
- Painful intensity> or = to 6/10 during the week preceding the inclusion - Medullary lesion, whatever the origin (traumatic, degenerative, tumoral, postoperative), responsible for paraplegia in a chronic state.
- Able to give informed consent, after clear, fair and appropriate information
- Having given their consent by a written consent signature.
Key exclusion criteria (7 listed)
- Hypersensitivity to ketamine or any of its components
- Participation in another interventional trial, or participation in another trial.
- Patient unable to give consent.
- Pregnancy or breastfeeding
- Refusal to sign the consent
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 |
|---|---|---|
| Ketamine 10 MG/MLKetamine infusion 1mg/kg with electric syringe during 2 hours. | Drug | Chronic neuropathic pain and bedsore Ketamine group, Chronic neuropathic pain without bedsore Ketamine group |
| PlacebosAlso: Sodium chloride infusionSodium chloride infusion with the same rate, electric syringe during 2 hours. | Drug | Chronic neuropathic pain and bedsore Placebo group, Chronic neuropathic pain without bedsore Placebo group |
| Midazolam 1 MG/MLBolus of Midazolam 1mg before each perfusion. | Drug | Chronic neuropathic pain and bedsore Ketamine group, Chronic neuropathic pain and bedsore Placebo group, Chronic neuropathic pain without bedsore Ketamine group, Chronic neuropathic pain without bedsore Placebo group |
Primary outcome
Numeric pain rating scale decrease between H0 and H4.
Time frame: 4 hours after the end of infusion
Numeric pain rating scale is a scale from 0 to 10. 0 is no pain, 10 is the worst pain we could imagine. The first outcome is decreasing the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points at H4. Comparison of groups two by two.
17 secondary outcomes
Paraclinical: Kynurenine pathway levels : SEROTONIN
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : KYNURENINE
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : IDO ACTIVITY
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : KYNURENIC ACID
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : QUINOLINIC ACID
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : IL1
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels : IL6
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Paraclinical: Kynurenine pathway levels: TNF alpha
Time frame: Hour 0 and Hour 6 (4 hours after the ending of infusion)
Clinical: Neuropathic pain symptom inventory
Time frame: Hour 0, Day 1, Day 4, Day 7
Clinical: Pain timeline
Time frame: Seven days
Percentage overall improvement in pain over a week with self assessment
Time frame: Between Hour 0 and Day 7
Clinical: Subscore of Neuropathic pain symptom inventory
Time frame: Hour 0, Day 1, Day 4, Day 7
Clinical: Hospital anxiety and depression scale
Time frame: Hour 0, Day 7.
Percentage overall improvement in mood over a week with self assessment
Time frame: Between Hour 0 and day 7
Clinical: Pain area on a body cartography
Time frame: Hour 0, Day 1, Day 7.
Clinical: Ketamine adverse effects
Time frame: Hour 0 to hour 4
Paraclinical: Kynurenine pathway activation with ulcer pressure
Time frame: Hour 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 39428602Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
- Individual participant dataSharing planned: No
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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.
Didier Bouhassira, Md, PhD study chair
INSERM U987
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine 10 MG/ML and Midazolam 1 MG/ML in people with Neuralgia and Chronic Pain, run by Redar 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 5 inclusion and 7 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 2 May 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Cyril QUEMENEUR, Resident (0033681193981, c.quemeneur@gmx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale decrease between H0 and H4. (time frame: 4 hours after the end of infusion). 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 NCT03513822, 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 2 May 2018.