Effects of Pregabalin on mechanical hyperalgesia - EPOM - EPOM

Conditions: G58.0
G59.8
G62.0 – 9
G63.2
G62.3
G63.8
G53.0
G55.0 – 8
G56.0 – 9
G57.0 – 9

Registration Number: EUCTR2005-000411-10-DE

Lead Sponsor: BG-Kliniken Bergmannsheil, Dept. of Pain Management

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

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, complex regional pain syndrome (CRPS);
• 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.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.

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. Extended specification for polyneuropathy: SRF outside normal range on one foot (normal range: women und 40 years: SRF > 4,65, women above 40 years: SRF > 5,71; men under 40 years: SRF > 7,10, men above 40 years: SRF> 4,49) OR SRF within normal range, but SRF affected/control at least 2.0 with a minimal SRF of 0.8 with a control region located at the ipsilateral hand.

Enrolment double-blind phase
• At least 30% reduction in mechanical hyperalgesia (SRF) (=”clinically meaningful reduction”) 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.