Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
| Status: | Withdrawn |
|---|---|
| Conditions: | Neurology, Hematology, Pain |
| Therapuetic Areas: | Hematology, Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2018 |
| Start Date: | January 2014 |
| End Date: | December 2015 |
A Phase 4, Randomized, Double-blind, Placebo-controlled, Cross-over Clinical Trial of a Single Shot of Intrathecal Ziconotide for the Treatment of Chronic, Medically Refractory Pain From Painful Peripheral Neuropathy or Myelopathy
This is a phase 4 study being conducted at the Ohio State University Department of Neurology
Multiple Sclerosis Research Program. The purpose of the study is to administer a single shot
of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or
spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain
from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has
not responded to other pain medicines.
Multiple Sclerosis Research Program. The purpose of the study is to administer a single shot
of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or
spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain
from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has
not responded to other pain medicines.
Study Hypothesis: We intend to determine if a single shot trial (SST) of intrathecal (IT)
ziconotide will temporarily reduce pain in these patients. In the proposed study, patients
will receive two injections, one of which is the ziconotide and one which is a placebo. They
will be blinded and not know which order they receive the treatment versus placebo. The
results of this clinical trial will provide a focused examination of ziconotide efficacy and
safety in patients with painful neuropathies or myelopathies that have not been effectively
treated with other pain medications. Moreover, the use of a single shot trial (SST) IT
injection in the outpatient setting will provide evidence for application of this technique
in outpatient neurological clinical practice, thereby improving access to this specific
patient population. Ziconotide is currently FDA approved for this indication and route of
administration. Therefore, a study design that improves the feasibility of ziconotide
trialing specifically in the neurology clinic (that is, single shot administration) is being
used in order to ensure its broader use by neurologists who routinely care for neuropathy and
myelopathy patients. Information from this study will also inform future studies of
predictors for long term efficacy after pump placement.
ziconotide will temporarily reduce pain in these patients. In the proposed study, patients
will receive two injections, one of which is the ziconotide and one which is a placebo. They
will be blinded and not know which order they receive the treatment versus placebo. The
results of this clinical trial will provide a focused examination of ziconotide efficacy and
safety in patients with painful neuropathies or myelopathies that have not been effectively
treated with other pain medications. Moreover, the use of a single shot trial (SST) IT
injection in the outpatient setting will provide evidence for application of this technique
in outpatient neurological clinical practice, thereby improving access to this specific
patient population. Ziconotide is currently FDA approved for this indication and route of
administration. Therefore, a study design that improves the feasibility of ziconotide
trialing specifically in the neurology clinic (that is, single shot administration) is being
used in order to ensure its broader use by neurologists who routinely care for neuropathy and
myelopathy patients. Information from this study will also inform future studies of
predictors for long term efficacy after pump placement.
Inclusion Criteria:
1. Men or women 18 years or older.
2. Neuropathic pain due to peripheral neuropathy or myelopathy
3. Duration of condition greater than 6 months
4. Inadequate control with trials of three or more analgesic agents considered standard
care for treatment of neuropathic pain; treatment failure can be either due to lack of
efficacy or to intolerable side effects.
5. Documented normal CK and GFR within 6 months preceding screening.
6. Baseline BPI pain severity subscale score of >5/10
Exclusion Criteria:
1. Renal insufficiency
2. History of Myopathy or persistently elevated CK levels
3. History of prior suicide attempt or ideation
4. History of Psychosis
5. Pregnancy or breastfeeding
6. Inability or unwillingness to use contraception
7. Inability to provide consent
8. Inability to tolerate lumbar punctures
9. Receiving systemic anticoagulation therapy (eg. Coumadin)
10. Inability/unwilling to self-catheterize if indicated
11. Change (start, stop, adjust) in home medications 30 days prior to screening visit.
12. Baseline CES-D score > 30
13. Subject has previously failed ziconotide treatment
14. Other factors that in the opinion of the PI would exclude the subject from
participation in the study
We found this trial at
1
site
Click here to add this to my saved trials
