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Sponsors and Collaborators: |
Professional Associations Clinic Bergmannsheil German Federal Ministry of Education and Research |
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Information provided by: | Professional Associations Clinic Bergmannsheil |
ClinicalTrials.gov Identifier: | NCT00310583 |
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.
Condition | Intervention | Phase |
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Tactile Hyperalgesia Neuropathic Pain |
Drug: Pregabalin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Pregabalin on Mechanical Hyperalgesia - EPOM |
Estimated Enrollment: | 120 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Recruitment:
Enrolment open titration:
Enrolment double-blind phase:
Exclusion Criteria:
Contact: Christoph Maier, Prof. MD | +49 (0)234 - 302 - 6366 | christoph.maier@rub.de |
Germany | |
Dept. of Neurology, University of Ulm | Recruiting |
Ulm, Germany, 89075 | |
Contact: Bernhard G. Landwehrmeyer, Prof. MD +49(0)731-500-50950 bernhard.landwehrmeyer@uni-ulm.de | |
Principal Investigator: Bernhard G. Landwehrmeyer, Prof. MD | |
Sub-Investigator: Roland Klug, MD | |
Dept. of Anaesthesia and Transfusion Medicine, University of Tuebingen | Not yet recruiting |
Tuebingen, Germany, 72076 | |
Contact: Sabine Bredanger, MD +49(0)7071-29-85612 sabine.bredanger@med.uni-tuebingen.de | |
Sub-Investigator: Sabine Bredanger, MD | |
Principal Investigator: Klaus Unertl, Prof. MD | |
Interdisciplinary Dept. of Pain Management, Dept. of Anaesthesiology, Ludwig-Maximilians-University | Not yet recruiting |
Munich, Germany, 81377 | |
Contact: Shanhnaz C Azad, PD MD +49(0)89-7094-4464 Shahnaz.Azad@med.uni-muenchen.de | |
Principal Investigator: Shanhaz C Azad, PD MD | |
Sub-Investigator: Meike Lauchert, MD | |
Sub-Investigator: Volker Huge, MD | |
Dept. of Anaesthesiology, University Hospital of Erlangen | Not yet recruiting |
Erlangen, Germany, 91054 | |
Contact: Wolfgang Koppert, PD MD +49(0)9131-85-32901 koppert@kfa.imed.uni-erlangen.de | |
Principal Investigator: Wolfgang Koppert, PD MD | |
Insitute of Physiology and Experimental Pathophysiology | Not yet recruiting |
Erlangen, Germany, 91054 | |
Contact: Christian Maihöfner, MD +49(0)9131-85-22498 christian.maihoefner@neuro.imed.uni-erlangen.de | |
Principal Investigator: Christian Maihöfner, MD | |
Dept. of Neurology, Universtity Hospital TU Munich | Not yet recruiting |
Munich, Germany, 81675 | |
Contact: Thomas R Toelle, Prof. MD +49(0)89-4140-4603 toelle@neuro.med.tu-muenchen.de | |
Principal Investigator: Thomas R Toelle, Prof. MD | |
Sub-Investigator: Michael Valet, MD | |
Sub-Investigator: Till Sprenger, MD | |
Sub-Investigator: Dorothee Nietzsche, MD | |
Sub-Investigator: Christoph Bach, MD | |
Sub-Investigator: Achim Berthele, PD MD | |
University Hospital of Duesseldorf, Dept. of Paintherapy, Dept. of Anaesthesiology | Not yet recruiting |
Duesseldorf, Germany, 40225 | |
Contact: Rainer Freynhagen, MD +49(0)211-81-19157 freynhagen@med.uni-duesseldorf.de | |
Principal Investigator: Rainer Freynhagen, MD | |
Sub-Investigator: Andrea Schmitz, MD | |
Sub-Investigator: Peter Busche, MD | |
Berufsgenossenschaftliche Kliniken Bergmannsheil, Dept. of Anaesthesiology, Intensive Care and Pain Therapy, Dept. of Pain Therapy | Recruiting |
Bochum, Germany, 44789 | |
Contact: Christhop Maier, Prof. MD +49(0)234-302-6366 christoph.maier@rub.de | |
Principal Investigator: Christoph Maier, Prof. MD | |
Sub-Investigator: Andrea Scherens, MD | |
Neurological University Hospital, University of Freiburg | Not yet recruiting |
Freiburg, Germany, 79106 | |
Contact: Ingolf C Bötefür, MD +49(0)761-270-5001 botefur@nz.ukl.uni-freiburg.de | |
Principal Investigator: Ingolf C Bötefür, MD | |
DRK - Pain Centre Mainz | Recruiting |
Mainz, Germany, 55131 | |
Contact: Susann Seddigh, MD +49(0)6131-988510 susann.seddigh@drk-schmerz-zentrum.de | |
Principal Investigator: Susann Seddigh, MD | |
Health Care Centre, Dept. of Neurology, Johannes Gutenberg University of Mainz | Recruiting |
Mainz, Germany, 55101 | |
Contact: Frank Birklein, Prof. MD +49(0)6131-17-3270 birklein@neurologie.klinik.uni-mainz.de | |
Principal Investigator: Frank Birklein, Prof. MD | |
Sub-Investigator: Christian Gerber, MD | |
Sub-Investigator: Roman Rolke, MD | |
Dept. of Neurology, Neurological Section, Pain Research and Therapy, Universitätsklinikum Schleswig-Holstein, Campus Kiel | Recruiting |
Kiel, Germany, 24105 | |
Contact: Ralf Baron, Prof. MD +49(0)431-597-1809 r.baron@neurologie.uni-kiel.de | |
Principal Investigator: Ralf Baron, Prof. MD | |
Sub-Investigator: Andreas Binder, MD | |
Sub-Investigator: Janne Ludwig, MD | |
Sub-Investigator: J Schattschneider, MD | |
Neurological Hospital, University of Wuerzburg | Not yet recruiting |
Wuerzburg, Germany, 97080 | |
Contact: Claudia Sommer, Prof. MD +49(0)931-201-23763 sommer@mail.uni-wuerzburg.de | |
Principal Investigator: Claudia Sommer, Prof. MD | |
Sub-Investigator: Nurcan Uceler, MD | |
Pain Therapy, Dept. of Anaesthesiology and Intensive Care Medicine, University of Cologne | Not yet recruiting |
Cologne, Germany, 50924 | |
Contact: Frank Petzke, MD +49(0)221-478-3627 frank.petzke@uni-koeln.de | |
Sub-Investigator: Thorsten Giesecke, MD | |
Principal Investigator: Frank Petzke, PD MD | |
Pain Therapy, Dept. of Anaestesiology and Intensive Care Medicine, Clinical Medicine Mannheim, University of Heidelberg | Not yet recruiting |
Mannheim, Germany, 68167 | |
Contact: Ulrike Friess, MD +49(0)621-383-2608 ulrike.friess@anaes.ma.uni-heidelberg.de | |
Principal Investigator: Ulrike Friess, MD | |
Dept. of Neuroradiology, Neurological Health Care Center, University Hospital of Heidelberg | Not yet recruiting |
Heidelberg, Germany, 69120 | |
Contact: Christoph Stippich, PD MD +49(0)6221-56-39607 christoph.stippich@med.uni-heidelberg.de | |
Principal Investigator: Christoph Stippich, PD MD | |
Anesthesiology and Surgical Intensive Care Medicine, University of Muenster | Not yet recruiting |
Muenster, Germany, 48149 | |
Contact: Esther Pogatzki-Zahn, PD MD +49(0)251-834-7258 pogatzki@anit.uni-muenste.de | |
Principal Investigator: Esther Pogatzki-Zahn, PD MD |
Study Director: | Christoph Maier, Prof. MD. | Professional Associations Clinic Bergmannsheil , Dept. of Pain Therapy |
Study ID Numbers: | 2005-000411-10, BfArM61-3910-4030984, 4478944789, EV2005-2509 |
Study First Received: | April 3, 2006 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00310583 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
tactile hyperalgesia neuropathic pain enriched design peripheral nerve lesion plexus lesion |
radicular lesion spinal lesion polyneuropathy postzosteric neuralgia |
Signs and Symptoms Sensation Disorders Somatosensory Disorders Neuralgia Polyneuropathies Pregabalin |
Neurologic Manifestations Pain Peripheral Nervous System Agents Analgesics Hyperalgesia Anticonvulsants |
Sensation Disorders Nervous System Diseases Physiological Effects of Drugs Pregabalin Hyperalgesia Pharmacologic Actions Somatosensory Disorders Signs and Symptoms |
Sensory System Agents Therapeutic Uses Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |