Ketamine and Neuropathic Pain (KETAPAIN)

• ClinicalTrials.gov Identifier: NCT02467517
• Recruitment Status: Unknown
• First Posted: June 10, 2015
• Last Update Posted: July 29, 2016
• Sponsor: University Hospital, Clermont-Ferrand
• Information provided by (Responsible Party): University Hospital, Clermont-Ferrand

Tracking Information

• First Submitted Date: May 29, 2015
• First Posted Date: June 10, 2015
• Last Update Posted Date: July 29, 2016
• Study Start Date: November 2015
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 5, 2015): Numerical rating scale (NRS) [ Time Frame: at day 1 and for a period of 5 weeks (35 days). ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2015)

• Intensity of the average [ Time Frame: at day 1 ]
  Intensity of the average daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet
• Intensity of maximum daily pain [ Time Frame: at day 1 ]
  Intensity of maximum daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet,
• Impact on quality of life [ Time Frame: at day 1 ]
  Impact on quality of life, mood and sleep assessed by questionnaires.
• Impact on mood [ Time Frame: at day 1 ]
  Impact on quality of life, mood and sleep assessed by questionnaires.
• Impact on sleep [ Time Frame: at day 1 ]
  Impact on quality of life, mood and sleep assessed by questionnaires.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine and Neuropathic Pain
• Official Title: Ketamine and Neuropathic Pain

Brief 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. - 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,
2. - To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo,
3. - 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Neuropathic Pain

Intervention

• Drug: Ketamine
• Drug: Magnesium Sulfate
• Drug: placebo : sodium chloride

Study Arms

Experimental: INTRAVENOUS KETAMINE

Interventions:

• Drug: Ketamine
• Drug: Magnesium Sulfate
• Drug: placebo : sodium chloride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 5, 2015): 22
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2018
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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;
• 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.

Exclusion Criteria:

• 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;
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02467517
• Other Study ID Numbers: CHU-0235
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Clermont-Ferrand
• Study Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gisèle PICKERING; University Hospital, Clermont-Ferrand

• PRS Account: University Hospital, Clermont-Ferrand
• Verification Date: July 2016