Painful MyelopathyPhase 4NCT01992562
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
A Phase 4 study testing Ziconotide in people with Painful Myelopathy and Painful Neuropathy, run by Aaron Boster at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Myelopathy, Painful Neuropathy
- What is being tested?
- Ziconotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 4
- 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
- Men or women 18 years or older.
- Neuropathic pain due to peripheral neuropathy or myelopathy
- Duration of condition greater than 6 months
- 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.
- Documented normal CK and GFR within 6 months preceding screening.
- Baseline BPI pain severity subscale score of >5/10
Who cannot join
- Renal insufficiency
- History of Myopathy or persistently elevated CK levels
- History of prior suicide attempt or ideation
- History of Psychosis
- Pregnancy or breastfeeding
- Inability or unwillingness to use contraception
Show all 14Show fewer
- Inability to provide consent
- Inability to tolerate lumbar punctures
- Receiving systemic anticoagulation therapy (eg. Coumadin)
- Inability/unwilling to self-catheterize if indicated
- Change (start, stop, adjust) in home medications 30 days prior to screening visit.
- Baseline CES-D score > 30
- Subject has previously failed ziconotide treatment
- Other factors that in the opinion of the PI would exclude the subject from participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Department of Neurology
Columbus, Ohio, 43221
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Painful Myelopathy, Painful Neuropathy
- Being tested
- Ziconotide, placebo
- Medical subject headings
- Neuropathy, Painful
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiconotideDrug
Also called Prialt
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 5 mcg ziconotide in 1ml of normal saline bolus intrathecal injection Receives: Drug: Ziconotide |
| Placebo | Placebo comparator | 1ml of normal saline bolus intrathecal injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale of Pain Intensity (VASPI)
The primary outcome measure of this study is to determine the efficacy of single shot IT ziconotide in treatment of refractory neuropathic pain as a result of painful peripheral neuropathy or myelopathy and to determine the maximal decrease from baseline in VASPI (Visual Analog Scale of Pain Intensity). A responder analysis will also be performed for the VASPI.
Measured: within 8 hours post injection
Secondary outcomes (4)
Numerical Rating Scale of Pain (NRS)
Used to measure pain intensity on a 0-10 scale.
Measured: within 8 hours of Injection
Brief Pain Inventory (BPI) Scale
Used to assess the severity of pain and the impact of pain on daily functions.
Measured: within a week of Injection
Pittsburgh Sleep Quality Index (PSQI)
Used to measure the quality and patterns of sleep in adults.
Measured: within a week of injection
Patient Global Impression of Change (PGIC)
Used to assess the patient's belief about the efficacy of their treatment.
Measured: within 8 hours of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Logistical issues with study process and recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful MyelopathyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Boster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron Boster, OhioHealth
- Investigators
- Aaron L Boster, MD, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992562
- Sponsor's protocol ID
- PRIALT01
- Status last verified
- Sep 2018
- First submitted
- 19 Nov 2013
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01992562
- Acronym / sponsor ID
- PRIALT01
- Conditions
- Painful Myelopathy, Painful Neuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical issues with study process and recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aaron BosterUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Nov 2013 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Ziconotide5 mcg ziconotide in 1ml of normal saline bolus intrathecal injection |
| Placebo | Placebo comparator | Drug: placebo1ml of normal saline bolus intrathecal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women 18 years or older.
- Neuropathic pain due to peripheral neuropathy or myelopathy
- Duration of condition greater than 6 months
- 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.
- Documented normal CK and GFR within 6 months preceding screening.
Key exclusion criteria (14 listed)
- Renal insufficiency
- History of Myopathy or persistently elevated CK levels
- History of prior suicide attempt or ideation
- History of Psychosis
- Pregnancy or breastfeeding
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 |
|---|---|---|
| ZiconotideAlso: Prialt | Drug | Treatment |
| placebo | Drug | Placebo |
Primary outcome
Visual Analog Scale of Pain Intensity (VASPI)
Time frame: within 8 hours post injection
The primary outcome measure of this study is to determine the efficacy of single shot IT ziconotide in treatment of refractory neuropathic pain as a result of painful peripheral neuropathy or myelopathy and to determine the maximal decrease from baseline in VASPI (Visual Analog Scale of Pain Intensity). A responder analysis will also be performed for the VASPI.
4 secondary outcomes
Numerical Rating Scale of Pain (NRS)
Time frame: within 8 hours of Injection
Brief Pain Inventory (BPI) Scale
Time frame: within a week of Injection
Pittsburgh Sleep Quality Index (PSQI)
Time frame: within a week of injection
Patient Global Impression of Change (PGIC)
Time frame: within 8 hours of injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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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.
Aaron L Boster, MD principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ziconotide in people with Painful Myelopathy and Painful Neuropathy, run by Aaron Boster at 1 site in United States.
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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 18 Sep 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale of Pain Intensity (VASPI) (time frame: within 8 hours post injection). 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 18 Sep 2018.