NCT01373983

Brief Summary

The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

3.3 years

First QC Date

May 25, 2011

Last Update Submit

December 28, 2014

Conditions

Peripheral Neuropathy

Keywords

Neuropathic painIntrathecal analgesiaZiconotideBolustraumacentralseverechronic

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm

    The average VASPI-score post-injection will be compared to the pre-injection value to yield a percentage pain reduction. Positive outcome is defined as a reduction of ≥30% in VASPI on two consecutive occasions at the same dosage without significant adverse events. All other cases will be considered as negative outcome.

    VASPI before injection and then each hour after injection, for 6 hours.

Study Arms (1)

ziconotide

OTHER
Drug: Ziconotide

Interventions

ZiconotideDRUG

1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm

Also known as: Prialt
ziconotide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient, at least 18 years of age
  • suffering from severe chronic (≥ 6 months) pain, who has failed on conventional pharmacological treatment
  • only patients with peripheral neuropathic pain or central neuropathic pain, due to trauma or surgery, will be included
  • Average usual VASPI last week ≥ 40 mm
  • Patient capable of judgment, i.e. able to understand information regarding the drug, the mode of administration and evaluation of efficacy and side effects Signed informed consent

You may not qualify if:

  • Limited life expectancy (investigator's judgement)
  • Intrathecal chemotherapy
  • Known or suspected intracranial hypertension
  • Known liver or kidney disease, defined as ASAT, ALAT, Total Bilirubin, ALP or S- Creatinine \> 1.2 x ULN
  • Advanced cardio-pulmonary disease (investigator's judgment)
  • Ongoing infection, whether systemically or locally in the lumbar area
  • Coagulopathy (including medication with warfarin, clopidogrel and heparin)
  • Allergy to ziconotide or any of the excipients in the ziconotide vial
  • History of psychiatric disorders which in the investigator's opinion would put the patient at risk
  • Pregnant or lactating woman.
  • Menstruating women must use an effective contraceptive method (contraceptive pill or intrauterine spiral) during the trial period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain and Rehabilitation Centre, University Hospital

Linköping, SE-581 85, Sweden

Location

Related Publications (1)

  • Jonsson M, Gerdle B, Ghafouri B, Backryd E. The inflammatory profile of cerebrospinal fluid, plasma, and saliva from patients with severe neuropathic pain and healthy controls-a pilot study. BMC Neurosci. 2021 Feb 1;22(1):6. doi: 10.1186/s12868-021-00608-5.

    PMID: 33522900DERIVED

MeSH Terms

Conditions

Peripheral Nervous System DiseasesNeuralgiaWounds and InjuriesLymphoma, FollicularBronchiolitis Obliterans Syndrome

Interventions

ziconotide

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host Disease

Study Officials

  • Emmanuel Bäckryd, MD

    Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seniro Consultant in Pain management

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 15, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

SE(1)