Effects of Pregabalin on Mechanical Hyperalgesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Professional Associations Clinic Bergmannsheil.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Professional Associations Clinic Bergmannsheil
ClinicalTrials.gov Identifier:
NCT00310583
First received: April 3, 2006
Last updated: April 4, 2007
Last verified: April 2006
  Purpose

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
Tactile Hyperalgesia
Neuropathic Pain
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Pregabalin on Mechanical Hyperalgesia - EPOM

Resource links provided by NLM:


Further study details as provided by Professional Associations Clinic Bergmannsheil:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

Estimated Enrollment: 120
Study Start Date: July 2006
Estimated Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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;
  • 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).

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310583

Contacts
Contact: Christoph Maier, Prof. MD +49 (0)234 - 302 - 6366 christoph.maier@rub.de

Locations
Germany
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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 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         
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         
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         
Sponsors and Collaborators
Professional Associations Clinic Bergmannsheil
German Federal Ministry of Education and Research
Investigators
Study Director: Christoph Maier, Prof. MD. Professional Associations Clinic Bergmannsheil , Dept. of Pain Therapy
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00310583     History of Changes
Other Study ID Numbers: 2005-000411-10, BfArM61-3910-4030984, 4478944789, EV2005-2509
Study First Received: April 3, 2006
Last Updated: April 4, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Professional Associations Clinic Bergmannsheil:
tactile hyperalgesia
neuropathic pain
enriched design
peripheral nerve lesion
plexus lesion
radicular lesion
spinal lesion
polyneuropathy
postzosteric neuralgia

Additional relevant MeSH terms:
Neuralgia
Hyperalgesia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014