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Clinical Trials/EUCTR2004-005024-40-LV
EUCTR2004-005024-40-LVActive, not recruitingNot Applicable

A multicentre, randomised, double-blind, placebo controlled, parallel group study to evaluate the safety and efficacy of lamotrigine 200-400 mg/ day compared with placebo in subjects with painful diabetic neuropathy.

GlaxoSmithKline Research & Development Limited0 sites498 target enrollmentStarted: May 11, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
498
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •A subject will be eligible for inclusion in this study only if all of the following criteria
  • •1. Male or female outpatients at least 18 years of age.
  • •2. Clinical diagnosis of type 1 or type 2 diabetes mellitus.
  • •3. Distal symmetric sensorimotor polyneuropathy defined by any of the following
  • •abnormalities:
  • •Bilateral impaired or absent reflexes at the ankles
  • •Bilateral impaired vibration, pinprick, fine touch or temperature perception in
  • •the distal lower extremities
  • •Note: Specific nerve conduction velocity findings are not required for inclusion.
  • •4. A hemoglobin A1c concentration < 8% at entry into the study. Subjects with a
  • •hemoglobin A1c concentration of 8-11% can be included, if in the opinion of the
  • •investigator, attempts have been made by the subject to improve diabetic control but
  • •these attempts have failed.
  • •5. Stable glycemic control for three months prior to the time of investigational product randomization. If necessary, diabetes medication regimens may be changed after randomization if needed to maintain glycemic control.
  • •Stable glycemic control medication doses for subjects using insulin are defined as =
  • •25% change of habitual insulin dose needed to maintain blood glucose.
  • •For subjects using oral antidiabetic medications, stable glycemic medication doses
  • •are defined as = 50% change in habitual doses of oral antidiabetic medications.
  • •Those subjects with diet controlled diabetes are eligible if stable glycemic control
  • •6. Pain associated with diabetic neuropathy for at least 6 months but no longer than 5 years prior to enrollment. Subjects who have had pain associated with diabetic neuropathy for > 5 years can be included if a documented diagnosis of diabetic neuropathy by a neurologist exists.
  • •7. Baseline pain intensity scores averaging = 5.0 during the Baseline Phase and at least four days of pain (PI-NRS >0) recorded during the last seven days of that phase.
  • •8. If female, the subject is eligible to enter and participate in this study if she is not
  • •lactating and is of:
  • •a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
  • •including any female who is pre-menarchial or post-menopausal [defined as one
  • •year without menses]); or,
  • •b. child-bearing potential, has a negative urine pregnancy test at screen (prior to
  • •investigational product administration), and agrees to one of the acceptable
  • •methods of contraception as noted in Section 14.3., Appendix 3: Acceptable
  • •Methods of Contraception”.
  • •9. Is able to understand the study procedures, schedule and able to comply with study requirements including use of acetaminophen/paracetamol only as rescue analgesia, completion of electronic-diary, and questionnaires without assistance as well as walking 50 feet (15 meters) during a visit without help.
  • •10. A signed and dated written informed consent is obtained from the subject or the
  • •subject’s legally acceptable representative prior to study participation.
  • •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

  • •A subject will not be eligible for inclusion in this study if any of the following criteria
  • •1. Subject has other pain condition(s) not associated with painful diabetic neuropathy.
  • •However, the subject will not be excluded if the pain condition is:
  • •at a different region of the body
  • •the intensity of the pain is not greater than the intensity of the painful diabetic
  • •neuropathy.
  • •2. Lower extremity pain of any severity due to mononeuropathy, osteoarthritis of the ankle or foot, gout, bursitis, or fasciitis.
  • •3. Diffuse peripheral neuropathy attributable to other causes (e.g., alcoholism,
  • •malignancy, HIV, syphilis, drug abuse, peripheral ischemia, B-12 deficiency,
  • •hypothyroidism, liver disease, toxic exposure, significant focal neuropathy in the
  • •lower extremities, or acute or chronic poly-radiculopathy.
  • •4. Pain attributed to focal or multifocal diabetic neuropathies including
  • •mononeuropathies of the cranial nerve, trunk and limb, entrapment or asymmetric
  • •lower limb motor neuropathy (amyotrophy) or symmetric proximal lower limb motor
  • •neuropathy (amyotrophy). However, the subject will not be excluded from study
  • •participation if amyotrophic pain has resolved after at least one year and the current
  • •pain is due to distal symmetric sensorimotor polyneuropathy.
  • •5. Multiple sclerosis or other conditions commonly associated with central neuropathic pain.
  • •6. Unable to discontinue prohibited medications 2 weeks prior to the time of
  • •investigational product administration and throughout the duration of the study.
  • •(Note: Adenosine, topical capsaicin applied for the relief of target pain or intrathecal
  • •peptides must be discontinued 4 weeks prior to the time of investigational product
  • •administration and throughout the duration of the study.
  • •7. Initiation of a new analgesic for continuous use throughout the study is not allowed.
  • •However, short-term use of NSAID or COX-2 inhibitor analgesics for new, acute
  • •conditions can be added for pain not related to painful diabetic neuropathy for up to
  • •8. Nerve blocks or acupuncture for the relief of diabetic neuropathic pain performed
  • •four (4) weeks prior to the time of investigational product administration and
  • •throughout the duration of the study.
  • •9. Non-drug therapies or any other special procedures (e.g. TENS) administered for the relief of diabetic neuropathic pain 2 weeks prior to the time of investigational
  • •product administration and throughout the duration of the study. (TENS
  • •administered for pain removed from the site of diabetic neuropathic pain is
  • •acceptable.)
  • •10. Presence of any condition, physical examination finding or laboratory test result
  • •which, in the opinion of the investigator, could interfere with the evaluation of the
  • •subject, accurate completion of the symptom scale, interpretation of efficacy or
  • •safety data, or compliance with the protocol requirements. This includes, but is not
  • •limited to:
  • •Skin conditions at site of neuropathy that could alter sensation
  • •Lower extremity amputations other than toes
  • •Active infection at site of neuropathy
  • •11. Medical history or clinical evidence of major depression or a psychiatric condition
  • •that would interfere with safe participation in this study. A subject with major
  • •depression controlled by selective serotonin reuptake inhibitors will not be excluded
  • •from study participation.
  • •12. Subject has a history of clinically significant drug or alcohol abuse, as defined by the Diagnostic and Statistical M

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