Peripheral Nerve InjuriesPhase 2RUFPTPSNCT02095899
Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome
A Phase 2 study testing Rufinamide in people with Peripheral Nerve Injuries and Pain, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Nerve Injuries, Pain
- What is being tested?
- Rufinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years
- Weight: 50 - 100kg
- Height: 155 - 195cm
- Sufficient command of German language
- Patient after thoracotomy
- Pain duration of more than 6 month.
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- Diagnosis of Neuropathic Pain (DN4 questionnaire)
- Average baseline mean last week pain intensity =5 on NRS (numerical rating scale)
- Signed and dated informed consent
- Stable analgesic regimen for at least 7 days prior to randomisation
- Patients not reaching a NRS = 3 (numeric rating scale) with the baseline individually dose adjusted treatment (oxycodone).
Who cannot join
- Contraindications to the class of drugs under study, e.g. (rufinamide, oxycodone) known hypersensitivity or allergy this class of drugs
- Hypersensitivity to triazole derivates - antifungal drugs including: fluconazole (e.g. Diflucan®), posaconazole (Noxafil®), itraconazole (Sporanox®), voriconazole (Vfend®)
- Lactose intolerance, galactosemia or galactokinase deficiency, glucose-galactose malabsorption
- Use of topical analgesics, or nerve block of the affected or adjacent dermatomes (less than to 2 weeks prior to the therapy onset visit or during the study period)
- Women who are pregnant or breast feeding; intention to become pregnant during the course of the study, lack of safe contraception, defined as: female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not willing or able to use any other second (additional) considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, severe cardiovascular disease, etc)
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- Creatinine clearance = 30 ml/min (estimated from serum creatinine using the Cockcroft - Gault formula) were excluded
- Known drug (opiate or other) or alcohol abuse
- Contraindication to the use of oxycodone
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- Participation in another study with investigational drugs within the 30 days preceding and during the present study
- Enrollment of the investigators, his/her family members, employees and other dependent persons
- Known neurological disease with peripheral manifestations including neuropathy associated with disease such as diabetes
- Known sensory changes from other medical conditions (e.g. infections affecting the investigation areas, post-herpetic neuralgia)
- Epilepsy
- Abnormal electrocardiogram (especially Familial Short QT syndrome)
- Patient having another pain condition with greater pain intensity
- Repeated thoracic surgeries
- Pneumonectomy or chest wall resection
- Bilateral thoracic surgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Institut of Anaesthesiology
Zurich, Canton of Zurich, 8091
About this study
Official title: Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.
The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.
Read the detailed description
Patients with chronic neuropathic pain after thoracic surgery will be evaluated and treated with oxycodone. Patients with a stable analgesic regimen, not reaching a good pain relief will be randomized to receive Rufinamide (Inovelon)vs. Placebo as an ad-on treatment to oxycodone. Neurophysiological and clinical data will be monitored.
- Conditions
- Peripheral Nerve Injuries, Pain
- Being tested
- Rufinamide
- Keywords
- Thoracic Surgical Procedures
- Medical subject headings
- Peripheral Nerve Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RufinamideDrug
Also called Inovelon
2x200mg up to max 2x800mg a day Titration over 20days
| Study group | Role | What they receive |
|---|---|---|
| Rufinamide | Experimental | - oral Rufinamide administration as ad-on to Oxycodone Receives: Drug: Rufinamide |
| Manitol | Placebo comparator | - oral Placebo administration - as ad-on to Oxycodone Receives: Drug: Rufinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of punctuate hyperalgesia immediately after topical capsaicin.
The primary variable to test is the area of punctuate hyperalgesia after topical capsaicin application in patients treated with rufinamide versus placebo.
Measured: 2h after capsaicin removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Poor study patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad Maurer, MD, Principal investigator, University Hospital Zurich, Institut of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095899
- Sponsor's protocol ID
- 2013-253
- Acronym
- RUFPTPS
- Status last verified
- Jul 2015
- First submitted
- 14 Feb 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.
- ClinicalTrials.gov ID
- NCT02095899
- Acronym / sponsor ID
- RUFPTPS / 2013-253
- Conditions
- Peripheral Nerve Injuries, Pain
- Keywords
- Thoracic Surgical Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor study patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Mar 2014 (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.
The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.
Detailed description
Patients with chronic neuropathic pain after thoracic surgery will be evaluated and treated with oxycodone. Patients with a stable analgesic regimen, not reaching a good pain relief will be randomized to receive Rufinamide (Inovelon)vs. Placebo as an ad-on treatment to oxycodone. Neurophysiological and clinical data will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rufinamide | Experimental | Drug: Rufinamide- oral Rufinamide administration as ad-on to Oxycodone |
| Manitol | Placebo comparator | Drug: Rufinamide- oral Placebo administration - as ad-on to Oxycodone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 18-75 years
- Weight: 50 - 100kg
- Height: 155 - 195cm
- Sufficient command of German language
- Patient after thoracotomy
Key exclusion criteria (20 listed)
- Contraindications to the class of drugs under study, e.g. (rufinamide, oxycodone) known hypersensitivity or allergy this class of drugs
- Hypersensitivity to triazole derivates - antifungal drugs including: fluconazole (e.g. Diflucan®), posaconazole (Noxafil®), itraconazole (Sporanox®), voriconazole (Vfend®)
- Lactose intolerance, galactosemia or galactokinase deficiency, glucose-galactose malabsorption
- Use of topical analgesics, or nerve block of the affected or adjacent dermatomes (less than to 2 weeks prior to the therapy onset visit or during the study period)
- Women who are pregnant or breast feeding; intention to become pregnant during the course of the study, lack of safe contraception, defined as: female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not willing or able to use any other second (additional) considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential
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 |
|---|---|---|
| RufinamideAlso: Inovelon2x200mg up to max 2x800mg a day Titration over 20days | Drug | Manitol, Rufinamide |
Primary outcome
Area of punctuate hyperalgesia immediately after topical capsaicin.
Time frame: 2h after capsaicin removal
The primary variable to test is the area of punctuate hyperalgesia after topical capsaicin application in patients treated with rufinamide versus placebo.
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 21 Jul 2015.
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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.
Konrad Maurer, MD principal investigator
University Hospital Zurich, Institut of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rufinamide in people with Peripheral Nerve Injuries and Pain, run by University of Zurich at 1 site in Switzerland.
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 11 inclusion and 20 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 21 Jul 2015. 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Area of punctuate hyperalgesia immediately after topical capsaicin. (time frame: 2h after capsaicin removal). 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 21 Jul 2015.