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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.
Show all 11Show fewer
  • 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
Show all 9Show fewer
  • 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.

France1 site
  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

Other trials in France

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.

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 groups in NCT01602185
Study groupRoleWhat they receive
memantineExperimentalThe 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)
dextromethorphanExperimentalThe 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)
placeboPlacebo comparatorThe 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.

  1. Measure of pain by numerical scale

    Measured: at Day 30

Secondary outcomes (10)
  1. Measure of pain by numerical scale

    Measured: at day 60 and at day 90

  2. Patient Global Impression if Change (PGIC)

    Measured: at day 30, at day 60 and at day 90

  3. Leed's slip questionnaire

    Measured: at day 30, at day 60 and at day 90

  4. Questionnaire of quality of life SF 36

    Measured: at day 30, at day 60 and at day 90

  5. DN4 scale

    Measured: at day 30, at day 60 and at day 90

  6. Neuropathic Pain Symptoms Inventory (NPSI)

    Measured: at day 30, at day 60 and at day 90

  7. Saint-Antoine questionnaire (QDSA)

    Measured: at day 30, at day 60 and at day 90

  8. HAD scale

    Measured: at day 30, at day 60 and at day 90

  9. Questionnaire of identification of pain (QCD)

    Measured: at day 30, at day 60 and at day 90

  10. 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.

  1. First posted18 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJun 2014
  4. Study completion7 Sep 2016

Resources

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)
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 31447547
  • Pickering 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

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.

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