Neuropathic PainPhase 2NMDANCT01602185
Study of NMDA Antagonists and Neuropathic Pain
A Phase 2 study testing Dextromethorphan (drug used like antitussive) and Memantine (drug used in Alzheimer's disease) in people with Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity. In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Dextromethorphan (drug used like antitussive) and Memantine (drug used in Alzheimer's disease)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to 7 Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- patient suffering chronic neuropathic pain
- All chronic pain is retained except central or diabetic pain
- Answering patient at ketamine in pain treatment by investigator, and having already received ketamine
- Patient who completed before ketamine the following evaluation :
- DN4, QCD, QDSA, PGIC questionnaires, HAD scale, Leed's sleep evaluation and SF36.
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- Patient who completed at the end of treatment the following evaluation : numerical scale and PGIC
- Sufficient cooperation and understanding to comply to the requirements of study
- Acceptance to give a written concert
- Affiliation at system of French social security
- Inscription or acceptation of inscription at national register of voluntaries participant at research
Who cannot join
- Against-indication at memantine or dextromethorphan administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency
- Patient with medical or surgical antecedents
- Patient with progressive disease at balance of inclusion
- Patient treated by an IMAO
- Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman
- Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial
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- Patient with cooperation and understanding insufficiency to comply to the requirements of protocol
- Patient with social protection
- No affiliation at system of French social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antagonists NMDA in Relay to Ketamine in Neuropathic Pain
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.
In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.
Read the detailed description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.
In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.
- Conditions
- Neuropathic Pain
- Being tested
- Dextromethorphan (drug used like antitussive), Memantine (drug used in Alzheimer's disease), Placebo (lactose)
- Keywords
- NMDA (N-Methyl-D-Aspartate) antagonists, ketamine, memantine, dextromethorphan, Neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextromethorphan (drug used like antitussive)Drug
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Memantine (drug used in Alzheimer's disease)Drug
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
Placebo (lactose)Drug
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
| Study group | Role | What they receive |
|---|---|---|
| memantine | Experimental | The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity Receives: Drug: Memantine (drug used in Alzheimer's disease) |
| dextromethorphan | Experimental | The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity Receives: Drug: Dextromethorphan (drug used like antitussive) |
| placebo | Placebo comparator | The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity Receives: Drug: Placebo (lactose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of pain by numerical scale
Measured: at Day 30
Secondary outcomes (10)
Measure of pain by numerical scale
Measured: at day 60 and at day 90
Patient Global Impression if Change (PGIC)
Measured: at day 30, at day 60 and at day 90
Leed's slip questionnaire
Measured: at day 30, at day 60 and at day 90
Questionnaire of quality of life SF 36
Measured: at day 30, at day 60 and at day 90
DN4 scale
Measured: at day 30, at day 60 and at day 90
Neuropathic Pain Symptoms Inventory (NPSI)
Measured: at day 30, at day 60 and at day 90
Saint-Antoine questionnaire (QDSA)
Measured: at day 30, at day 60 and at day 90
HAD scale
Measured: at day 30, at day 60 and at day 90
Questionnaire of identification of pain (QCD)
Measured: at day 30, at day 60 and at day 90
Evaluation of cognitive impact (Cantab, Cambridge)
Measured: at day 30, at day 60 and at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completion7 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital, Dr Marc Sorel, Pain Clinic, Nemours Hospital, Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital, Dr Monique Belon, Pain Clinic, Aurillac Hospital, Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital, Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital, Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602185
- Sponsor's protocol ID
- CHU-0112
- Acronym
- NMDA
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2012
- Last updated
- 21 Apr 2026
- Results posted
- No
Publications
Martin E, Sorel M, Morel V, Marcaillou F, Picard P, Delage N, Tiberghien F, Crosmary MC, Najjar M, Colamarino R, Creach C, Lietar B, Brumauld de Montgazon G, Margot-Duclot A, Loriot MA, Narjoz C, Lambert C, Pereira B, Pickering G. Dextromethorphan and memantine after ketamine analgesia: a randomized control trial. Drug Des Devel Ther. 2019 Aug 2;13:2677-2688. doi: 10.2147/DDDT.S207350. eCollection 2019.
PubMed 31447547Pickering G, Pereira B, Morel V, Tiberghien F, Martin E, Marcaillou F, Picard P, Delage N, de Montgazon G, Sorel M, Roux D, Dubray C. Rationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients. Contemp Clin Trials. 2014 Jul;38(2):314-20. doi: 10.1016/j.cct.2014.06.004. Epub 2014 Jun 16.
PubMed 24948402
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antagonists NMDA in Relay to Ketamine in Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01602185
- Acronym / sponsor ID
- NMDA / CHU-0112
- Conditions
- Neuropathic Pain
- Keywords
- NMDA (N-Methyl-D-Aspartate) antagonists, ketamine, memantine, dextromethorphan, Neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital, Dr Marc Sorel, Pain Clinic, Nemours Hospital, Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital, Dr Monique Belon, Pain Clinic, Aurillac Hospital, Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital, Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital, Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital
- Study start
- May 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- 7 Sep 2016 (actual)
- First posted
- 18 May 2012 (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 aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.
In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.
Detailed description
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.
In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| memantine | Experimental | Drug: Memantine (drug used in Alzheimer's disease)The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity |
| dextromethorphan | Experimental | Drug: Dextromethorphan (drug used like antitussive)The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity |
| placebo | Placebo comparator | Drug: Placebo (lactose)The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- > 18 years old
- patient suffering chronic neuropathic pain
- All chronic pain is retained except central or diabetic pain
- Answering patient at ketamine in pain treatment by investigator, and having already received ketamine
- Patient who completed before ketamine the following evaluation :
Key exclusion criteria (9 listed)
- Against-indication at memantine or dextromethorphan administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency
- Patient with medical or surgical antecedents
- Patient with progressive disease at balance of inclusion
- Patient treated by an IMAO
- Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman
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 |
|---|---|---|
| Dextromethorphan (drug used like antitussive)The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity | Drug | dextromethorphan |
| Memantine (drug used in Alzheimer's disease)The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity | Drug | memantine |
| Placebo (lactose)The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity | Drug | placebo |
Primary outcome
Measure of pain by numerical scale
Time frame: at Day 30
10 secondary outcomes
Measure of pain by numerical scale
Time frame: at day 60 and at day 90
Patient Global Impression if Change (PGIC)
Time frame: at day 30, at day 60 and at day 90
Leed's slip questionnaire
Time frame: at day 30, at day 60 and at day 90
Questionnaire of quality of life SF 36
Time frame: at day 30, at day 60 and at day 90
DN4 scale
Time frame: at day 30, at day 60 and at day 90
Neuropathic Pain Symptoms Inventory (NPSI)
Time frame: at day 30, at day 60 and at day 90
Saint-Antoine questionnaire (QDSA)
Time frame: at day 30, at day 60 and at day 90
HAD scale
Time frame: at day 30, at day 60 and at day 90
Questionnaire of identification of pain (QCD)
Time frame: at day 30, at day 60 and at day 90
Evaluation of cognitive impact (Cantab, Cambridge)
Time frame: at day 30, at day 60 and at day 90
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 21 Apr 2026.
- Results publication: PubMed 31447547Martin E, Sorel M, Morel V, Marcaillou F, Picard P, Delage N, Tiberghien F, Crosmary MC, Najjar M, Colamarino R, Creach C, Lietar B, Brumauld de Montgazon G, Margot-Duclot A, Loriot MA, Narjoz C, Lambert C, Pereira B, Pickering G. Dextromethorphan and memantine after ketamine analgesia: a randomized control trial. Drug Des Devel Ther. 2019 Aug 2;13:2677-2688. doi: 10.2147/DDDT.S207350. eCollection 2019.
- Derived from this study: PubMed 24948402Pickering G, Pereira B, Morel V, Tiberghien F, Martin E, Marcaillou F, Picard P, Delage N, de Montgazon G, Sorel M, Roux D, Dubray C. Rationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients. Contemp Clin Trials. 2014 Jul;38(2):314-20. doi: 10.1016/j.cct.2014.06.004. Epub 2014 Jun 16.
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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.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
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 Dextromethorphan (drug used like antitussive) and Memantine (drug used in Alzheimer's disease) in people with Neuropathic Pain, run by University Hospital, Clermont-Ferrand 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 11 inclusion and 9 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 21 Apr 2026. 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?
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?
Measure of pain by numerical scale (time frame: at Day 30). 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 NCT01602185, which also lists 2 linked publications.
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 2026.