Neuropathic PainPhase 2KETAPAINNCT02467517
Ketamine and Neuropathic Pain
A Phase 2 study testing Ketamine and Magnesium Sulfate in people with Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to that of a placebo in patients with refractory neuropathic pain. The secondary outcomes are: 1. 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?
- Ketamine and Magnesium Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Apr 2018
- 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
- Patient (s) are at least18 years old, with chronic pain (for more than 3 months), having the characteristics of a peripheral or central neuropathy, follow (s) at the Pain Clinic CHU Clermont-Ferrand and justifying the establishment of a therapeutic program including intravenous infusion of ketamine (as therapeutic test);
- Patient (s) who had never received ketamine infusion under the care of their neuropathic pain;
- History of illness compatible with an injury or disease of the somatosensory system;
- Localized pain in an anatomical neuro territory;
- Neurological examination shows sensory abnormalities,
- The patients of childbearing potential must use effective contraception throughout the study;
Show all 11Show fewer
- For womens of childbearing age, they will be enrolled in the study after a negative urine pregnancy test; in case of suspicion of pregnancy, a blood pregnancy test should be performed;
- Cooperation and willing to follow the study;
- Acceptance to give written consent;
- Affiliated to the French social security;
- Inscription or acceptation of inscription in the national register of volunteers involved in trials.
Who cannot join
- Patient (s) who have received intravenous ketamine infusion;
- Patients with one or many contraindication to ketamine administration: known hypersensitivity to ketamine in which one of the constituents of the product, uncontrolled high blood pressure, severe cardiac insufficiency;
- Patients with one or many contraindication of magnesium sulfate administration: Patients with severe renal impairment;
- Patients with one or many contraindication to administration of sodium chloride: water inflation, fluid retention;
- Patients with a medical history and / or surgical judged by the investigator to be not consistent with the clinical trial;
- Patients with drug treatments judged by the investigator to be not consistent with the clinical trial;
Show all 11Show fewer
- Pregnancy or lactation women;
- Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial;
- Patients with cooperation and understanding not to adhere strictly to the conditions provided in the clinical trial;
- Patients receiving a measure of legal protection (guardianship…);
- Patients are not affiliated to the System of the French Social Security
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Noémie DELAGE
About this study
The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to that of a placebo in patients with refractory neuropathic pain.
The secondary outcomes are:
- - To compare the additive analgesic efficacy of prior administration of magnesium sulfate to that of placebo and ketamine only, on the effectiveness of intravenous ketamine treatment,
- - To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo,
- - To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.
Read the detailed description
Description of the study:
Single-center clinical trial, controlled, randomized, double-blind, crossover design, against inactive placebo.
Each patient will receive successively the 3 products (ketamine / placebo, ketamine / magnesium sulfate, placebo / placebo) follows a predeter randomization list, with a wash-out period between each administration.
Visit 1
-Inclusion visit, signature of informed consent form, clinical examination and fill questionnaires.
For women of childbearing age a pregnancy test will be performed.The pain will be measured by a numerical scale.
The pain will be evaluated by scoring on a numerical scale. A booklet for monitoring analgesic concomitant medication and overall pain on a numerical scale will be given to the patient 14 days before the programmed infusion.
Visit 2 : Period 1 Day 0
Clinical examination, return of booklet completed by patient and fill questionnaires.
The pain will be evaluated by scoring on a numerical scale before and after the infusion.
For women of childbearing age a pregnancy test will be performed. Treatment allocation period follows a predeter randomization list. At the end of the infusion, a booklet for monitoring will be given to patients for the following weeks in order to score their overall pain until the next study period.
The output of the hospital patient (CPC / CETD) after each treatment will be authorized by the investigator.
Wash-out period: 5 weeks.
Phone call 1 (Day 1):
Patients will be called by phone to collect adverse events and concomitant medications. If necessary, the patients should return to consult the CPC / CETD for a clinical examination.
Patients will be called the week before their scheduled visit, if at that time their spontaneous pain is still low, according to the opinion of the investigator, the infusion visit will be shifted to allow the pain level back its basal level.
Visit 3 : Period 2 : Day 36 +/- 3 days
Same of period 1.
Phone call 2 J 37 +/- 3 days:
Same of phone call 1.
Visit 4 : Period 3 : Day 72 +/- 3 days
Same of period 1
Phone call 3 J 73 +/- 3 days:
Same of phone call 1.
Visit 5 : Day 108 +/- 3 days
Clinical examination, return of booklet completed by patient and fill questionnaires.
The pain will be evaluated by scoring on a numerical scale For women of childbearing age a pregnancy test will be performed. This visit is the end of the study.
- Conditions
- Neuropathic Pain
- Being tested
- Ketamine, Magnesium Sulfate, placebo : sodium chloride
- Keywords
- Neuropathic pain, Ketamine, Magnesium sulfate, Quality of life, Anxiety and depression, Mood and sleep
- Medical subject headings
- Neuralgia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Magnesium SulfateDrug
placebo : sodium chlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| INTRAVENOUS KETAMINE | Experimental | Not described Receives: Drug: Ketamine; Drug: Magnesium Sulfate; Drug: placebo : sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
Measured: at day 1 and for a period of 5 weeks (35 days).
Secondary outcomes (5)
Intensity of the average
Intensity of the average daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet
Measured: at day 1
Intensity of maximum daily pain
Intensity of maximum daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet,
Measured: at day 1
Impact on quality of life
Impact on quality of life, mood and sleep assessed by questionnaires.
Measured: at day 1
Impact on mood
Impact on quality of life, mood and sleep assessed by questionnaires.
Measured: at day 1
Impact on sleep
Impact on quality of life, mood and sleep assessed by questionnaires.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467517
- Sponsor's protocol ID
- CHU-0235
- Acronym
- KETAPAIN
- Status last verified
- Jul 2016
- First submitted
- 29 May 2015
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine and Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02467517
- Acronym / sponsor ID
- KETAPAIN / CHU-0235
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic pain, Ketamine, Magnesium sulfate, Quality of life, Anxiety and depression, Mood and sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 10 Jun 2015 (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 primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to that of a placebo in patients with refractory neuropathic pain.
The secondary outcomes are:
- - To compare the additive analgesic efficacy of prior administration of magnesium sulfate to that of placebo and ketamine only, on the effectiveness of intravenous ketamine treatment,
- - To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo,
- - To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.
Detailed description
Description of the study:
Single-center clinical trial, controlled, randomized, double-blind, crossover design, against inactive placebo.
Each patient will receive successively the 3 products (ketamine / placebo, ketamine / magnesium sulfate, placebo / placebo) follows a predeter randomization list, with a wash-out period between each administration.
Visit 1
-Inclusion visit, signature of informed consent form, clinical examination and fill questionnaires.
For women of childbearing age a pregnancy test will be performed.The pain will be measured by a numerical scale.
The pain will be evaluated by scoring on a numerical scale. A booklet for monitoring analgesic concomitant medication and overall pain on a numerical scale will be given to the patient 14 days before the programmed infusion.
Visit 2 : Period 1 Day 0
Clinical examination, return of booklet completed by patient and fill questionnaires.
The pain will be evaluated by scoring on a numerical scale before and after the infusion.
For women of childbearing age a pregnancy test will be performed. Treatment allocation period follows a predeter randomization list. At the end of the infusion, a booklet for monitoring will be given to patients for the following weeks in order to score their overall pain until the next study period.
The output of the hospital patient (CPC / CETD) after each treatment will be authorized by the investigator.
Wash-out period: 5 weeks.
Phone call 1 (Day 1):
Patients will be called by phone to collect adverse events and concomitant medications. If necessary, the patients should return to consult the CPC / CETD for a clinical examination.
Patients will be called the week before their scheduled visit, if at that time their spontaneous pain is still low, according to the opinion of the investigator, the infusion visit will be shifted to allow the pain level back its basal level.
Visit 3 : Period 2 : Day 36 +/- 3 days
Same of period 1.
Phone call 2 J 37 +/- 3 days:
Same of phone call 1.
Visit 4 : Period 3 : Day 72 +/- 3 days
Same of period 1
Phone call 3 J 73 +/- 3 days:
Same of phone call 1.
Visit 5 : Day 108 +/- 3 days
Clinical examination, return of booklet completed by patient and fill questionnaires.
The pain will be evaluated by scoring on a numerical scale For women of childbearing age a pregnancy test will be performed. This visit is the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTRAVENOUS KETAMINE | Experimental | Drug: Ketamine, Drug: Magnesium Sulfate, Drug: placebo : sodium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient (s) are at least18 years old, with chronic pain (for more than 3 months), having the characteristics of a peripheral or central neuropathy, follow (s) at the Pain Clinic CHU Clermont-Ferrand and justifying the establishment of a therapeutic program including intravenous infusion of ketamine (as therapeutic test);
- Patient (s) who had never received ketamine infusion under the care of their neuropathic pain;
- History of illness compatible with an injury or disease of the somatosensory system;
- Localized pain in an anatomical neuro territory;
- Neurological examination shows sensory abnormalities,
Key exclusion criteria (11 listed)
- Patient (s) who have received intravenous ketamine infusion;
- Patients with one or many contraindication to ketamine administration: known hypersensitivity to ketamine in which one of the constituents of the product, uncontrolled high blood pressure, severe cardiac insufficiency;
- Patients with one or many contraindication of magnesium sulfate administration: Patients with severe renal impairment;
- Patients with one or many contraindication to administration of sodium chloride: water inflation, fluid retention;
- Patients with a medical history and / or surgical judged by the investigator to be not consistent with the clinical trial;
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 | Drug | INTRAVENOUS KETAMINE |
| Magnesium Sulfate | Drug | INTRAVENOUS KETAMINE |
| placebo : sodium chloride | Drug | INTRAVENOUS KETAMINE |
Primary outcome
Numerical rating scale (NRS)
Time frame: at day 1 and for a period of 5 weeks (35 days).
5 secondary outcomes
Intensity of the average
Time frame: at day 1
Intensity of maximum daily pain
Time frame: at day 1
Impact on quality of life
Time frame: at day 1
Impact on mood
Time frame: at day 1
Impact on sleep
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
Related trials for Neuropathic Pain
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
Recruiting
Post Operative Pain and Vagal Stimulation
Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic)
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 Ketamine and Magnesium Sulfate 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 11 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 29 Jul 2016. 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. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) (time frame: at day 1 and for a period of 5 weeks (35 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2016.