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Effects of Pregabalin on Mechanical Hyperalgesia

Primary Purpose

Tactile Hyperalgesia, Neuropathic Pain

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Pregabalin

About this trial

This is an interventional treatment trial for Tactile Hyperalgesia focused on measuring tactile hyperalgesia, neuropathic pain, enriched design, peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Berufsgenossenschaftliche Kliniken Bergmannsheil, Dept. of Anaesthesiology, Intensive Care and Pain Therapy, Dept. of Pain TherapyRecruiting
Pain Therapy, Dept. of Anaesthesiology and Intensive Care Medicine, University of Cologne
University Hospital of Duesseldorf, Dept. of Paintherapy, Dept. of Anaesthesiology
Dept. of Anaesthesiology, University Hospital of Erlangen
Insitute of Physiology and Experimental Pathophysiology
Neurological University Hospital, University of Freiburg
Dept. of Neuroradiology, Neurological Health Care Center, University Hospital of Heidelberg
Dept. of Neurology, Neurological Section, Pain Research and Therapy, Universitätsklinikum Schleswig-Holstein, Campus KielRecruiting
Health Care Centre, Dept. of Neurology, Johannes Gutenberg University of MainzRecruiting
DRK - Pain Centre MainzRecruiting
Pain Therapy, Dept. of Anaestesiology and Intensive Care Medicine, Clinical Medicine Mannheim, University of Heidelberg
Anesthesiology and Surgical Intensive Care Medicine, University of Muenster
Interdisciplinary Dept. of Pain Management, Dept. of Anaesthesiology, Ludwig-Maximilians-University
Dept. of Neurology, Universtity Hospital TU Munich
Dept. of Anaesthesia and Transfusion Medicine, University of Tuebingen
Dept. of Neurology, University of UlmRecruiting
Neurological Hospital, University of Wuerzburg

Outcomes

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)

Full Information

NCT ID

NCT00310583

First Posted

April 3, 2006

Last Updated

April 4, 2007

Sponsor

Professional Associations Clinic Bergmannsheil

Collaborators

German Federal Ministry of Education and Research

1. Study Identification

Unique Protocol Identification Number

NCT00310583

Brief Title

Effects of Pregabalin on Mechanical Hyperalgesia

Official Title

Effects of Pregabalin on Mechanical Hyperalgesia - EPOM

Study Type

Interventional

2. Study Status

Record Verification Date

April 2006

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Professional Associations Clinic Bergmannsheil

Collaborators

German Federal Ministry of Education and Research

4. Oversight

5. Study Description

Brief 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tactile Hyperalgesia, Neuropathic Pain

Keywords

tactile hyperalgesia, neuropathic pain, enriched design, peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Degree of mechanical hyperalgesia

Title

Ongoing pain (numerical rating scale)

Title

Neuropathic Pain Symptom Inventory score

Title

Additional QST (qualitative sensory testing) variable CDT = cold detection threshold,

Title

Additional QST (qualitative sensory testing) variable HDT = heat detection threshold

Title

Additional QST (qualitative sensory testing) variable TSL = thermal sensory limen

Title

Additional QST (qualitative sensory testing) variable PHS = number of paradoxical heat sensations during the TSL Procedure

Title

Additional QST (qualitative sensory testing) variable CPT = cold pain threshold

Title

Additional QST (qualitative sensory testing) variable HPT = heat pain threshold

Title

Additional QST (qualitative sensory testing) variable MDT = mechanical detection threshold

Title

Additional QST (qualitative sensory testing) variable MPT = mechanical pain threshold

Title

Additional QST (qualitative sensory testing) variable ALL = dynamic mechanical allodynia

Title

Additional QST (qualitative sensory testing) variable WUR = windup ratio

Title

Additional QST (qualitative sensory testing) variable VDT = vibration detection threshold

Title

Additional QST (qualitative sensory testing) variable PPT = pressure pain threshold)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Maier, Prof. MD

Phone

+49 (0)234 - 302 - 6366

christoph.maier@rub.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Maier, Prof. MD.

Organizational Affiliation

Professional Associations Clinic Bergmannsheil , Dept. of Pain Therapy

Official's Role

Study Director

Facility Information:

Facility Name

Berufsgenossenschaftliche Kliniken Bergmannsheil, Dept. of Anaesthesiology, Intensive Care and Pain Therapy, Dept. of Pain Therapy

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christhop Maier, Prof. MD

Phone

+49(0)234-302-6366

christoph.maier@rub.de

First Name & Middle Initial & Last Name & Degree

Christoph Maier, Prof. MD

First Name & Middle Initial & Last Name & Degree

Andrea Scherens, MD

Facility Name

Pain Therapy, Dept. of Anaesthesiology and Intensive Care Medicine, University of Cologne

City

Cologne

ZIP/Postal Code

50924

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frank Petzke, MD

Phone

+49(0)221-478-3627

frank.petzke@uni-koeln.de

First Name & Middle Initial & Last Name & Degree

Thorsten Giesecke, MD

First Name & Middle Initial & Last Name & Degree

Frank Petzke, PD MD

Facility Name

University Hospital of Duesseldorf, Dept. of Paintherapy, Dept. of Anaesthesiology

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rainer Freynhagen, MD

Phone

+49(0)211-81-19157

freynhagen@med.uni-duesseldorf.de

First Name & Middle Initial & Last Name & Degree

Rainer Freynhagen, MD

First Name & Middle Initial & Last Name & Degree

Andrea Schmitz, MD

First Name & Middle Initial & Last Name & Degree

Peter Busche, MD

Facility Name

Dept. of Anaesthesiology, University Hospital of Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wolfgang Koppert, PD MD

Phone

+49(0)9131-85-32901

koppert@kfa.imed.uni-erlangen.de

First Name & Middle Initial & Last Name & Degree

Wolfgang Koppert, PD MD

Facility Name

Insitute of Physiology and Experimental Pathophysiology

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Maihöfner, MD

Phone

+49(0)9131-85-22498

christian.maihoefner@neuro.imed.uni-erlangen.de

First Name & Middle Initial & Last Name & Degree

Christian Maihöfner, MD

Facility Name

Neurological University Hospital, University of Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ingolf C Bötefür, MD

Phone

+49(0)761-270-5001

botefur@nz.ukl.uni-freiburg.de

First Name & Middle Initial & Last Name & Degree

Ingolf C Bötefür, MD

Facility Name

Dept. of Neuroradiology, Neurological Health Care Center, University Hospital of Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Stippich, PD MD

Phone

+49(0)6221-56-39607

christoph.stippich@med.uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Christoph Stippich, PD MD

Facility Name

Dept. of Neurology, Neurological Section, Pain Research and Therapy, Universitätsklinikum Schleswig-Holstein, Campus Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ralf Baron, Prof. MD

Phone

+49(0)431-597-1809

r.baron@neurologie.uni-kiel.de

First Name & Middle Initial & Last Name & Degree

Ralf Baron, Prof. MD

First Name & Middle Initial & Last Name & Degree

Andreas Binder, MD

First Name & Middle Initial & Last Name & Degree

Janne Ludwig, MD

First Name & Middle Initial & Last Name & Degree

J Schattschneider, MD

Facility Name

Health Care Centre, Dept. of Neurology, Johannes Gutenberg University of Mainz

City

Mainz

ZIP/Postal Code

55101

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frank Birklein, Prof. MD

Phone

+49(0)6131-17-3270

birklein@neurologie.klinik.uni-mainz.de

First Name & Middle Initial & Last Name & Degree

Frank Birklein, Prof. MD

First Name & Middle Initial & Last Name & Degree

Christian Gerber, MD

First Name & Middle Initial & Last Name & Degree

Roman Rolke, MD

Facility Name

DRK - Pain Centre Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susann Seddigh, MD

Phone

+49(0)6131-988510

susann.seddigh@drk-schmerz-zentrum.de

First Name & Middle Initial & Last Name & Degree

Susann Seddigh, MD

Facility Name

Pain Therapy, Dept. of Anaestesiology and Intensive Care Medicine, Clinical Medicine Mannheim, University of Heidelberg

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulrike Friess, MD

Phone

+49(0)621-383-2608

ulrike.friess@anaes.ma.uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Ulrike Friess, MD

Facility Name

Anesthesiology and Surgical Intensive Care Medicine, University of Muenster

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Esther Pogatzki-Zahn, PD MD

Phone

+49(0)251-834-7258

pogatzki@anit.uni-muenste.de

First Name & Middle Initial & Last Name & Degree

Esther Pogatzki-Zahn, PD MD

Facility Name

Interdisciplinary Dept. of Pain Management, Dept. of Anaesthesiology, Ludwig-Maximilians-University

City

Munich

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shanhnaz C Azad, PD MD

Phone

+49(0)89-7094-4464

Shahnaz.Azad@med.uni-muenchen.de

First Name & Middle Initial & Last Name & Degree

Shanhaz C Azad, PD MD

First Name & Middle Initial & Last Name & Degree

Meike Lauchert, MD

First Name & Middle Initial & Last Name & Degree

Volker Huge, MD

Facility Name

Dept. of Neurology, Universtity Hospital TU Munich

City

Munich

ZIP/Postal Code

81675

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas R Toelle, Prof. MD

Phone

+49(0)89-4140-4603

toelle@neuro.med.tu-muenchen.de

First Name & Middle Initial & Last Name & Degree

Thomas R Toelle, Prof. MD

First Name & Middle Initial & Last Name & Degree

Michael Valet, MD

First Name & Middle Initial & Last Name & Degree

Till Sprenger, MD

First Name & Middle Initial & Last Name & Degree

Dorothee Nietzsche, MD

First Name & Middle Initial & Last Name & Degree

Christoph Bach, MD

First Name & Middle Initial & Last Name & Degree

Achim Berthele, PD MD

Facility Name

Dept. of Anaesthesia and Transfusion Medicine, University of Tuebingen

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sabine Bredanger, MD

Phone

+49(0)7071-29-85612

sabine.bredanger@med.uni-tuebingen.de

First Name & Middle Initial & Last Name & Degree

Sabine Bredanger, MD

First Name & Middle Initial & Last Name & Degree

Klaus Unertl, Prof. MD

Facility Name

Dept. of Neurology, University of Ulm

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernhard G. Landwehrmeyer, Prof. MD

Phone

+49(0)731-500-50950

bernhard.landwehrmeyer@uni-ulm.de

First Name & Middle Initial & Last Name & Degree

Bernhard G. Landwehrmeyer, Prof. MD

First Name & Middle Initial & Last Name & Degree

Roland Klug, MD

Facility Name

Neurological Hospital, University of Wuerzburg

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claudia Sommer, Prof. MD

Phone

+49(0)931-201-23763

sommer@mail.uni-wuerzburg.de

First Name & Middle Initial & Last Name & Degree

Claudia Sommer, Prof. MD

First Name & Middle Initial & Last Name & Degree

Nurcan Uceler, MD

12. IPD Sharing Statement

Links:

URL

http://www.bmbf.de/

Description

German Ministry of Education and Research

URL

http://www.bfarm.de

Description

German Federal Institute for Drugs and Medical Devices

URL

http://www.ruhr-uni-bochum.de/ethik/

Description

Ethics Committee, Medical Department of the Ruhr-University Bochum

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Effects of Pregabalin on Mechanical Hyperalgesia

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