DRUG
zicotinide followed by placebo
The experimental treatment period consists of Ziconotide solution that will be prepared by each local pharmacy team, in 5 or 10 milliliter (ml) vials with constant concentration of 10micrograms/mL
Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic
Status
Unknown
Phase
Phase 3
Enrollment
44
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Spinal cord injury (SCI) has an average prevalence of 50 per 100.000 in general population (30.000 patients with SCI in France) with estimates of the overall prevalence for severe neuropathic pain ranges from 30 to 51% (up to 10.000 patients in France). Patients with such spinal lesions may develop neuropathic pain called sublesional pain as perceived in an area below the level of injury. A second type of pain is at level of injury, i.e. perceived in a segmental pattern within the dermatome corresponding the spinal cord and nerve roots. These two types of pain are very harmful and are notoriously difficult to treat probably because of complex pathogenic mechanisms due to abnormal functioning of deafferented spinal and supraspinal nociceptive neurons. Opioids, whatever be the route of administration, had demonstrated their inefficacy for these patients as well as several surgical techniques. So, chronic pain in relation with spinal lesion can be defined as real refractory pain. Synaptic release of neurotransmitters is dependent on calcium intake trough voltage dependent channels. Type 2.1 or N-Type channels are specific for nociceptive system and can be blocked by a peptic neurotoxin: Ziconotide. Blocking these specific calcium channels neuromodulates nociception. Intrathecal use of Ziconotide, bringing the active molecule close to its receptors, has a proven clinical impact for a wide variety of pain (4). The intrathecal Ziconotide (ITZ) infusion using an implanted pump is validated for treatment of pain refractory to systemic analgesics (HAS, avis du 14-27 mai 2008). Meanwhile, no data are available in literature on positive effects of ITZ on specific spinal neuropathic pain. A pilot study was performed by the coordinator team using ITZ on 12 patients with spinal pain: 8 patients had \> 40% decrease of pain on numeric scale, 6 patients beneficiated from implanted pump allowing chronic ITZ treatment inducing 60% numeric scale decrease in average with 1 year follow-up. Therefore intrathecal Ziconotide could be an excellent candidate for the treatment of spinal pain where the pain generators may be difficult to target by other available treatments. This study is the first to assess ITZ (as IT antalgic monotherapy) versus placebo with a randomized controlled study with long follow-up. Trials have already been performed but not specially targeted spinal pain, and did not exceed three weeks follow-up. Long term effects of Ziconotide on memory, cognition and mood have not been evaluated. In fact even though short term adverse effects on higher level functions have been described they have not been assessed in a placebo controlled situation. Moreover, treating (successfully or not) patients with spinal pain could bring valuable insights both into the mechanisms of pain production in SCI patients and in the mechanisms of Ziconotide action: a positive result on pain below the injury level would imply action on the second or third order synapses of the nociceptive pathways. Similarly an effect at the level of pain, in absence of an effect below the level pain would argue discussion against such action. The impact of ITZ on the different clinical components of pain experienced by the patients, could also give some data on neuromodulation mechanism induced by the therapy.
Interventions
Treatment arms and agents.
DRUG
Placebo followed by zicotinide
The placebo treatment period consists in standard saline solution (preservative-free sodium chloride 9 milligram/milliliter (mg/ml) (0.9%) solution) which will be presented exactly in vials as presented for the treatment (volume, color, shape et size of the vial). Treating physicians will not be aware of the actual contents of the pump and will increase the volume of injected placebo as a treatment solution (as Ziconotide 10 micrograms/milliliter (μg/ml). The magnitude of increase is the decision of the treating physician (as long as it remains with the recommended limits by the Hospital Anxiety and Depression Scale (HAS) but most likely augmentations will be at maximum 1 microgram per month and maximum achieved doses allowed in SPIDOL study is 20 micrograms/day (in literature approximately 75% of patients who respond satisfactorily to treatment required a dose of ≤ 9.6 micrograms/day
Timeline
From registration to results.
First posted
May 8, 2019
Study start
Jun 20, 2019
Primary completion
Dec 20, 2019
Study completion
Sep 20, 2021
Results posted
Not reported
Registry updated
May 8, 2019
Outcomes
What the study measures.
Primary outcomes
Change in pain between both treatment arms assessed by the Visual Analogic Scale (VAS)
Time frame · 12 months
The primary endpoint is the comparison, for each patient, of the mean pain intensity, within the last two week before the end of treatment, between two conditions: under Intrathecal Ziconotide (ITZ) and intrathecal (IT) placebo, using a visual analogic scale (VAS). This VAS is a graduated line from 0 to 10, 0 being the lowest level of pain and 10 being the highest level of pain.The final endpoint will be measured after 6 months of treatment and 6 months of placebo (or vice versa according to the random assignation of first treatment in this cross over design study), that is to say after a total of 12 months of treatment.
Secondary outcomes
Evaluation of Long term analgesic effect of intrathecal Ziconotide assessed by the Visual Analogic Scale (VAS)
Time frame · 12 months
Continuous evaluation of pain intensity will be assessed using a visual analogic scale during the 12 months of treatment. Pain intensity will be measured using visual analogic scale (VAS). This VAS is a graduated line from 0 to 10 with 0 being the lowest level of pain and 10 being the highest level of pain . The patient identifies his level of pain on this graduated line.
Evaluation of Analgesic effect of at least 30%
Time frame · 12 months
Percentage of patients with at least 30% of pain reduction base on numeric scale within the last week before the end of treatment. Pain intensity will be measured using a visual analogic scale (VAS). This VAS is a graduated line from 0 to 10, 0 being the lowest level of pain and 10 being the highest level of pain. The patient identifies his level of pain on this graduated line.
Evaluation of Severe Adverse Events (SAE)
Time frame · over the 12 months
Declaration of all severe adverse event occurring during the 12 months period of treatment. Each event will be analyzed by an independent committee to evaluate the immutability of the experimental treatment.
Evaluation of patient satisfaction with pain treatment at first visit to refill the pump (1 month) assessed by the Visual Analogic Scale (VAS)
Time frame · 1 month
Satisfaction level of patient's pain relief will be assessed using a visual analogic scale (VAS). This VAS is a graduated line from 0 to 10, 0 being the lowest level of satisfaction and 10 being the highest satisfaction. The patient identifies his level of satisfaction of pain relief on this graduated line.
Evaluation patient satisfaction of pain relief with the treatment at 6 months assessed by the Visual Analogic Scale (VAS)
Time frame · 6 months
Satisfaction level of patient's pain relief will be assessed using a visual analogic scale (VAS). This VAS is a graduated line from 0 to 10, 0 being the lowest level of satisfaction and 10 being the highest satisfaction. The patient identifies his level of satisfaction of pain relief on this graduated line.
Evaluation patient satisfaction of pain relief with the treatment 12 months assessed by the Visual Analogic Scale (VAS)
Time frame · 12 months
Satisfaction level of patient's pain relief will be assessed using visual analogic scale (VAS). This VAS is a graduated line from 0 to 10, 0 being the lowest level of satisfaction and 10 being the highest satisfaction. The patient identifies his level of satisfaction of pain relief on this graduated line.
Analgesic effect on spontaneous pain duration
Time frame · 1 month before initiation of treatment
Duration (average time per day)
Analgesic effect on spontaneous pain duration
Time frame · 6 months
Duration (average time per day)
Analgesic effect on spontaneous pain duration
Time frame · 12 months
Duration (average time per day)
Analgesic effect on spontaneous pain intensity
Time frame · 1 month before initiation of treatment
Intensity of spontaneous pain will be assessed using a visual analogic scale (VAS). This VAS is a graduated line from 0 to 10, 0 being the lowest level of intensity of pain and 10 being the highest intensity of pain. The patient identifies his level of pain intensity on this graduated line.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * • Patient \> 18 year old * Patients with stabilized spinal cord lesion * Patients with refractory neuropathic pain with "Douleur Neuropathique" (DN4) score \>4 at selection and failure at least of 2 classes of antineuropathic pain drugs alone or in association * Experiences pain \> 5/10 on numeric scale * Patients with a positive trial test to Ziconotide either by lumbar puncture or by continuous infusion above the lesioned level via an implanted catheter * Evaluation performed both by a multidisciplinary team in a pain center and a rehabilitation center * Patients eligible to surgical implantation of a subcutaneous pump * Signed informed consent * Patients benefiting from a social insurance system or a similar system Exclusion Criteria: * • Life expectancy \< 5 years * Suffering from other neuropathic pain or chronic pain due to cancer * Being treated with spinal cord stimulation, nerve stimulation, intrathecal analgesic delivery system with analgesic drug (except Baclofen) until the last 6 months * Implant ITZ surgery contraindication (MRI or anesthesia contraindication, coagulation disorder, Immunodepression, current infection, critical respiratory and/or heart illness) * Unable to operate the ITZ equipment or comply with study requirements * Suspicion of substance abuse * Current or planned pregnancy * Patients with urinary tract disorder or urinary retention * Patient under or planning to go under electromagnetic transcranial stimulation or planning to * Patient unable to understand the purpose of the trial or refusing to follow treatment and post-treatment instructions * Patients with history of psychiatric disorder or hallucination * Participation to another trial that would interfere with this trial * Patients under legal protection
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Ziconotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
Clinique Bizet · Pancreatic Cancer Pain · Intrathecal Analgesic
Not applicable
Not yet recruiting
40
2026-07
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Christian Hospital Northeast Northwest · Chemotherapy Induced Peripheral Neuropathy (CIPN)
Not applicable
Not yet recruiting
24
2026-03
OP2C : Prialt® Observatory in Clinical Practice
Institut Cancerologie de l'Ouest · Refractory Pain
Not applicable
Recruiting
300
2025-08
Ziconotide for Non-cancer Pain by Intrathecal Administration
ESTEVE Pharmaceuticals SAS · Pain, Chronic
Not applicable
Recruiting
85
2025-02
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
National Cancer Institute, Naples · Pain · Neuropathic Pain
Phase 2
Unknown
16
2023-03
Ziconotide as First-Line IDT
Albany Medical College · Neuropathic Pain
Phase 4
Completed
13
2021-01
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Eisai Limited · Pain Management · Severe Chronic Pain
Not applicable
Completed
219
2018-10
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
Aaron Boster · Painful Myelopathy · Painful Neuropathy
Phase 4
Withdrawn
0
2018-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.