Tactile HyperalgesiaPhase 4NCT00310583
Effects of Pregabalin on Mechanical Hyperalgesia
A Phase 4 study testing Pregabalin in people with Tactile Hyperalgesia and Neuropathic Pain, run by Professional Associations Clinic Bergmannsheil at 17 sites in Germany.
Trial summary
The aim of this randomized placebo-controlled study is to evaluate the effects of analgetics for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain. Therefore the number of responders and non-responders on pregabalin will be evaluated in respect of mechanical hyperalgesia (stimulus-response-function… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tactile Hyperalgesia, Neuropathic Pain
- What is being tested?
- Pregabalin
- How many people
- 120 participants
- Where
- 17 sitesGermany
- Study dates
- Jul 2006to Apr 2008
- 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
- Recruitment:
- Age above 18 years;
- Neuropathic pain of at least 4/10 for at least 6 months;
- Mechanical hyperalgesia;
- One of the following diagnoses: peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia;
- No nerve block or other interventional treatment for at least 4 weeks;
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- Constant medication for at least 4 weeks;
- Signed informed consent;
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication;
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
- Enrolment open titration:
- All principal inclusion criteria at recruitment
- Relevant mechanical hyperalgesia: SRF affected/control at least 2.0 with a minimal SRF of 0.8.
- Enrolment double-blind phase:
- At least 30% reduction in mechanical hyperalgesia (SRF) in the open titration;
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication;
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study (see above recruitment).
Who cannot join
- Anaphylaxis on the active component or any other component of Lyrica or the placebo (Lyrica®: pregabalin, lactose-monohydrate, corn starch, talcum; capsule shells: gelatine, titanium dioxide (E 171), natriumdodecylsulfat, high dispersive siliciumdioxide, purified water; ink: shellac, black iron(II,III)-oxide (E 172), propyleneglycol, kaliumhydroxide; additionally in placebo: microcrystalline cellulose, sucrose octaacetate, magnesium stearate)
- Intake of gabapentin or pregabalin within the last 4 weeks prior to recruitment
- Any surgery within the last two months or any scheduled surgery within the study period (20 weeks);
- Concurrent unstable disease involving any system, e.g. advanced carcinoma, acute myocardial infarction, renal failure, or any other condition that in the opinion of the Investigator would deem the patient unsuitable for the study;
- History of cerebral vascular or other cerebral disease;
- Concurrent chronic or acute pain of other origin (osteoarthritis), which is not treated effectively
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- Concurrent severe mental deficit, e.g. psychiatric disorders as defined by DSM IV including schizophrenia, mood disorders, organic brain syndrome, psychotic/delusional disorders, serious psychosis;
- Concurrent serious neurological disease, e.g. dementia, multiple sclerosis, or any other disease that would have impact on the ability of the patient to give their consent for the participation in the study or influences the pain perception;
- Concurrent atrioventricular block second degree or higher
- Concurrent renal failure (CLcr < 30 ml/min)
- Concurrent hereditary galactose-intolerance
- Concurrent lapp-lactase insufficiency
- Concurrent glucose-galactose-malabsorption
- Concurrent sub-optimal stabilized Diabetes Mellitus (Hb1Ac > 12%)
- Clinical apparent overdosage of opioids or psychopharmaca
- Recent history (6 months) or current evidence of alcohol or drug abuse;
- Participation in any other investigational drug or therapy study within the previous 90 days;
- Women who are pregnant or breastfeeding;
- Women with a positive pregnancy test on enrollment or prior to study drug administration;
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Women practicing abstinence should use a reliable method of contraception (except birth control pills) if they choose to become sexually active during the study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites, 17 recruiting
- Recruiting
Berufsgenossenschaftliche Kliniken Bergmannsheil, Dept. of Anaesthesiology, Intensive Care and Pain Therapy, Dept. of Pain Therapy
Bochum, 44789
Christhop Maier, Prof. MD, +49(0)234-302-6366, christoph.maier@rub.de
Christoph Maier, Prof. MD
- Not yet recruiting
Pain Therapy, Dept. of Anaesthesiology and Intensive Care Medicine, University of Cologne
Cologne, 50924
Frank Petzke, MD, +49(0)221-478-3627, frank.petzke@uni-koeln.de
Thorsten Giesecke, MD
- Not yet recruiting
University Hospital of Duesseldorf, Dept. of Paintherapy, Dept. of Anaesthesiology
Düsseldorf, 40225
Rainer Freynhagen, MD, +49(0)211-81-19157, freynhagen@med.uni-duesseldorf.de
Rainer Freynhagen, MD
- Not yet recruiting
Dept. of Anaesthesiology, University Hospital of Erlangen
Erlangen, 91054
Wolfgang Koppert, PD MD, +49(0)9131-85-32901, koppert@kfa.imed.uni-erlangen.de
Wolfgang Koppert, PD MD
- Not yet recruiting
Insitute of Physiology and Experimental Pathophysiology
Erlangen, 91054
Christian Maihöfner, MD, +49(0)9131-85-22498, christian.maihoefner@neuro.imed.uni-erlangen.de
Christian Maihöfner, MD
- Not yet recruiting
Neurological University Hospital, University of Freiburg
Freiburg im Breisgau, 79106
Ingolf C Bötefür, MD, +49(0)761-270-5001, botefur@nz.ukl.uni-freiburg.de
Ingolf C Bötefür, MD
- Not yet recruiting
Dept. of Neuroradiology, Neurological Health Care Center, University Hospital of Heidelberg
Heidelberg, 69120
Christoph Stippich, PD MD, +49(0)6221-56-39607, christoph.stippich@med.uni-heidelberg.de
Christoph Stippich, PD MD
- Recruiting
Dept. of Neurology, Neurological Section, Pain Research and Therapy, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Ralf Baron, Prof. MD, +49(0)431-597-1809, r.baron@neurologie.uni-kiel.de
Ralf Baron, Prof. MD
- Recruiting
Health Care Centre, Dept. of Neurology, Johannes Gutenberg University of Mainz
Mainz, 55101
Frank Birklein, Prof. MD, +49(0)6131-17-3270, birklein@neurologie.klinik.uni-mainz.de
Frank Birklein, Prof. MD
- Recruiting
DRK - Pain Centre Mainz
Mainz, 55131
Susann Seddigh, MD, +49(0)6131-988510, susann.seddigh@drk-schmerz-zentrum.de
Susann Seddigh, MD
- Not yet recruiting
Pain Therapy, Dept. of Anaestesiology and Intensive Care Medicine, Clinical Medicine Mannheim, University of Heidelberg
Mannheim, 68167
Ulrike Friess, MD, +49(0)621-383-2608, ulrike.friess@anaes.ma.uni-heidelberg.de
Ulrike Friess, MD
- Not yet recruiting
Interdisciplinary Dept. of Pain Management, Dept. of Anaesthesiology, Ludwig-Maximilians-University
Munich, 81377
Shanhnaz C Azad, PD MD, +49(0)89-7094-4464, Shahnaz.Azad@med.uni-muenchen.de
Shanhaz C Azad, PD MD
- Not yet recruiting
Dept. of Neurology, Universtity Hospital TU Munich
Munich, 81675
Thomas R Toelle, Prof. MD, +49(0)89-4140-4603, toelle@neuro.med.tu-muenchen.de
Thomas R Toelle, Prof. MD
- Not yet recruiting
Anesthesiology and Surgical Intensive Care Medicine, University of Muenster
Münster, 48149
Esther Pogatzki-Zahn, PD MD, +49(0)251-834-7258, pogatzki@anit.uni-muenste.de
Esther Pogatzki-Zahn, PD MD
- Not yet recruiting
Dept. of Anaesthesia and Transfusion Medicine, University of Tuebingen
Tübingen, 72076
Sabine Bredanger, MD, +49(0)7071-29-85612, sabine.bredanger@med.uni-tuebingen.de
Sabine Bredanger, MD
- Recruiting
Dept. of Neurology, University of Ulm
Ulm, 89075
Bernhard G. Landwehrmeyer, Prof. MD, +49(0)731-500-50950, bernhard.landwehrmeyer@uni-ulm.de
Bernhard G. Landwehrmeyer, Prof. MD
- Not yet recruiting
Neurological Hospital, University of Wuerzburg
Würzburg, 97080
Claudia Sommer, Prof. MD, +49(0)931-201-23763, sommer@mail.uni-wuerzburg.de
Claudia Sommer, Prof. MD
About this study
Official title: Effects of Pregabalin on Mechanical Hyperalgesia - EPOM
The aim of this randomized placebo-controlled study is to evaluate the effects of analgetics for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain. Therefore the number of responders and non-responders on pregabalin will be evaluated in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick). The hypothesis is that in the placebo group the amount of non-responders is increased.
Read the detailed description
This randomized controlled trial is intended to be the first in a series of trials that will assess the efficacy of drugs, which relieve neuropathic pain, on stimulus-evoked pain (here: mechanical hyperalgesia to static punctate stimuli). Most drugs in this class (e.g. Gabapentin or NMDA receptor inhibitors) have NNT beyond 3 in patients with chronic pain, due to a response rate of 30 to 50 %. One potential reason for this low overall efficacy might be the presence of different pathophysiological mechanisms in subgroups of patients, who suffer from the same disease (e.g. postherpetic neuralgia, diabetic neuropathy). These mechanisms may include central sensitization on one hand and peripheral degeneration of afferent fibers on the other hand.
In this trial, we will use a battery of mechanical and thermal Quantitative Sensory Tests (QST), using non-nociceptive and low-intensity painful stimuli, to identify a subgroup of patients with mechanical hyperalgesia. To overcome the well-known low response rate in trials with neuropathic pain patients, an enriched design comparing active drugs with placebo will be performed, including only patients with high intensity of on-going pain in combination with mechanical hyperalgesia as sequelae of different, but well defined neurological disorders. The blinded phase of the trial will be restricted to so-called responders, i.e. patients with a clinically meaningful pain reduction of at least 30% in the primary end point (mechanical hyperalgesia). The second objective of this trial is to evaluate, whether the anti-hyperalgesic effect of the active drug is dependent on the QST profile.
- Conditions
- Tactile Hyperalgesia, Neuropathic Pain
- Being tested
- Pregabalin
- Keywords
- tactile hyperalgesia, neuropathic pain, enriched design, peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia
- Medical subject headings
- Hyperalgesia, Neuralgia, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
number of responders and non-responders in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick)
Secondary outcomes (15)
Degree of mechanical hyperalgesia
Ongoing pain (numerical rating scale)
Neuropathic Pain Symptom Inventory score
Additional QST (qualitative sensory testing) variable CDT = cold detection threshold,
Additional QST (qualitative sensory testing) variable HDT = heat detection threshold
Additional QST (qualitative sensory testing) variable TSL = thermal sensory limen
Additional QST (qualitative sensory testing) variable PHS = number of paradoxical heat sensations during the TSL Procedure
Additional QST (qualitative sensory testing) variable CPT = cold pain threshold
Additional QST (qualitative sensory testing) variable HPT = heat pain threshold
Additional QST (qualitative sensory testing) variable MDT = mechanical detection threshold
Additional QST (qualitative sensory testing) variable MPT = mechanical pain threshold
Additional QST (qualitative sensory testing) variable ALL = dynamic mechanical allodynia
Additional QST (qualitative sensory testing) variable WUR = windup ratio
Additional QST (qualitative sensory testing) variable VDT = vibration detection threshold
Additional QST (qualitative sensory testing) variable PPT = pressure pain threshold)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startJul 2006
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tactile HyperalgesiaStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Professional Associations Clinic Bergmannsheil
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Christoph Maier, Prof. MD., Study director, Professional Associations Clinic Bergmannsheil , Dept. of Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310583
- Sponsor's protocol ID
- 2005-000411-10
- Other IDs
- BfArM61-3910-4030984, 4478944789, EV2005-2509, 2005
- Status last verified
- Apr 2006
- First submitted
- 3 Apr 2006
- Last updated
- 5 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pregabalin on Mechanical Hyperalgesia - EPOM
- ClinicalTrials.gov ID
- NCT00310583
- Acronym / sponsor ID
- 2005-000411-10
- Conditions
- Tactile Hyperalgesia, Neuropathic Pain
- Keywords
- tactile hyperalgesia, neuropathic pain, enriched design, peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Professional Associations Clinic BergmannsheilUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jul 2006
- Study completion
- Apr 2008 (estimated)
- First posted
- 4 Apr 2006 (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 aim of this randomized placebo-controlled study is to evaluate the effects of analgetics for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain. Therefore the number of responders and non-responders on pregabalin will be evaluated in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick). The hypothesis is that in the placebo group the amount of non-responders is increased.
Detailed description
This randomized controlled trial is intended to be the first in a series of trials that will assess the efficacy of drugs, which relieve neuropathic pain, on stimulus-evoked pain (here: mechanical hyperalgesia to static punctate stimuli). Most drugs in this class (e.g. Gabapentin or NMDA receptor inhibitors) have NNT beyond 3 in patients with chronic pain, due to a response rate of 30 to 50 %. One potential reason for this low overall efficacy might be the presence of different pathophysiological mechanisms in subgroups of patients, who suffer from the same disease (e.g. postherpetic neuralgia, diabetic neuropathy). These mechanisms may include central sensitization on one hand and peripheral degeneration of afferent fibers on the other hand.
In this trial, we will use a battery of mechanical and thermal Quantitative Sensory Tests (QST), using non-nociceptive and low-intensity painful stimuli, to identify a subgroup of patients with mechanical hyperalgesia. To overcome the well-known low response rate in trials with neuropathic pain patients, an enriched design comparing active drugs with placebo will be performed, including only patients with high intensity of on-going pain in combination with mechanical hyperalgesia as sequelae of different, but well defined neurological disorders. The blinded phase of the trial will be restricted to so-called responders, i.e. patients with a clinically meaningful pain reduction of at least 30% in the primary end point (mechanical hyperalgesia). The second objective of this trial is to evaluate, whether the anti-hyperalgesic effect of the active drug is dependent on the QST profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age above 18 years;
- Neuropathic pain of at least 4/10 for at least 6 months;
- Mechanical hyperalgesia;
- One of the following diagnoses: peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia;
- No nerve block or other interventional treatment for at least 4 weeks;
Key exclusion criteria (20 listed)
- Anaphylaxis on the active component or any other component of Lyrica or the placebo (Lyrica®: pregabalin, lactose-monohydrate, corn starch, talcum; capsule shells: gelatine, titanium dioxide (E 171), natriumdodecylsulfat, high dispersive siliciumdioxide, purified water; ink: shellac, black iron(II,III)-oxide (E 172), propyleneglycol, kaliumhydroxide; additionally in placebo: microcrystalline cellulose, sucrose octaacetate, magnesium stearate)
- Intake of gabapentin or pregabalin within the last 4 weeks prior to recruitment
- Any surgery within the last two months or any scheduled surgery within the study period (20 weeks);
- Concurrent unstable disease involving any system, e.g. advanced carcinoma, acute myocardial infarction, renal failure, or any other condition that in the opinion of the Investigator would deem the patient unsuitable for the study;
- History of cerebral vascular or other cerebral disease;
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 |
|---|---|---|
| Pregabalin | Drug | – |
Primary outcome
number of responders and non-responders in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick)
15 secondary outcomes
Degree of mechanical hyperalgesia
Ongoing pain (numerical rating scale)
Neuropathic Pain Symptom Inventory score
Additional QST (qualitative sensory testing) variable CDT = cold detection threshold,
Additional QST (qualitative sensory testing) variable HDT = heat detection threshold
Additional QST (qualitative sensory testing) variable TSL = thermal sensory limen
Additional QST (qualitative sensory testing) variable PHS = number of paradoxical heat sensations during the TSL Procedure
Additional QST (qualitative sensory testing) variable CPT = cold pain threshold
Additional QST (qualitative sensory testing) variable HPT = heat pain threshold
Additional QST (qualitative sensory testing) variable MDT = mechanical detection threshold
Additional QST (qualitative sensory testing) variable MPT = mechanical pain threshold
Additional QST (qualitative sensory testing) variable ALL = dynamic mechanical allodynia
Additional QST (qualitative sensory testing) variable WUR = windup ratio
Additional QST (qualitative sensory testing) variable VDT = vibration detection threshold
Additional QST (qualitative sensory testing) variable PPT = pressure pain threshold)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
- German Ministry of Education and ResearchLink provided by the sponsor.
- German Federal Institute for Drugs and Medical DevicesLink provided by the sponsor.
- Ethics Committee, Medical Department of the Ruhr-University BochumLink provided by the sponsor.
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.
Christoph Maier, Prof. MD. study director
Professional Associations Clinic Bergmannsheil , Dept. of Pain Therapy
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Tactile Hyperalgesia and Neuropathic Pain, run by Professional Associations Clinic Bergmannsheil at 17 sites in Germany.
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 17 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: status not confirmed, as of the sponsor's last update on 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Maier, Prof. MD (+49 (0)234 - 302 - 6366, christoph.maier@rub.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of responders and non-responders in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick). 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 5 Apr 2007.