Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      Nowadays, available drugs cannot always produce pain relief in patients with neuropathic pain
      disease.

      It is believed that drugs acting as antagonists of the N-methyl-D-aspartic acid (NMDA)
      receptor may have been efficient in the treatment of neuropathic pain disorders.

      Ketamine is the only NMDA receptor antagonist commercially available in France. Ketamine is
      usually administered intravenously for surgical anesthesia.

      The intravenous administration of ketamine will be difficult to manage in the treatment of
      chronic neuropathic pain.

      Some trials using oral ketamine for the treatment of neuropathic pain were conducted but
      results were heterogeneous. This may be explained by the different range of ketamine doses
      tested.

      The aim of this clinical trial is to identify a safe and an efficient dose of orally
      administrated ketamine for the treatment of peripheral neuropathic pain.

      The clinical trial will be conducted in Toulouse Hospital, France. This study is a
      randomized, double-blind, placebo-controlled trial. The study will be conducted using 4
      parallel groups (three doses of ketamine versus placebo).
    

Detailed description: 
      In previous studies, it was shown that when ketamine was administrated by the intravenous
      route, its analgesic action was rapid. In one study, when oral ketamine was administrated to
      patients suffering from neuropathic pain, in six out of nine patients, pain was relieved
      after 24 hours post-administration.

      In this study, ketamine will be administrated during seven days, which will allow us to
      evaluate ketamine efficiency and safety.

      The effect of ketamine on pain intensity will be mainly studied using a visual analogue scale
      (VAS) but also taking into account the score assigned by the patient to his pain. This score
      will be noted down by patients before, during and after ketamine treatment.

      Evaluation of benefit/risk for ketamine administration during this trial, shows that even if
      adverse events are not excluded, the benefit for the patients may be neuropathic pain relief.

      Because clinical current knowledge regarding oral administration of ketamine is limited, this
      trial intends to enlarge information about ketamine efficiency and safety, more particularly
      in neuropathic pain disorders.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Initial dosage: 250 mg/5 ml
Three doses of ketamine will be tested:
0.35 mg/kg
0.7 mg/kg
1.4 mg/kg Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
The oral ketamine will be administered in form of syrup.
Other intervention name(s): Ketamine PANPHARMA
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Ketamine; pain; neuropathic pain; chronic