Lamotrigine for HIV-associated painful sensory neuropathies: A placebo-controlled trial

David M. Simpson, Justin Charles McArthur, R. Olney, D. Clifford, Y. So, D. Ross, B. J. Baird, P. Barrett, A. E. Hammer, R. Baker, R. Bartt, S. Becker, J. Berger, T. Brannagan, B. Cohen, C. Dorko, R. Ellis, D. M. Feinberg, K. Goodkin, C. HallP. Kumar, C. Marra, R. Pollard, G. Schifitto, A. Tselis, K. Vollmer

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate the efficacy and tolerability of lamotrigine (LTG) for the treatment of pain in HIVassociated sensory neuropathies. Methods: In a randomized, double-blind study, patients with HIV-associated distal sensory polyneuropathy (DSP) received LTG or placebo during a 7-week dose escalation phase followed by a 4-week maintenance phase. Randomization was stratified according to whether or not patients were currently using neurotoxic antiretroviral therapy (ART). Results: The number of patients randomized was 92 (62 LTG, 30 placebo) in the stratum receiving neurotoxic ART and 135 (88 LTG, 47 placebo) in the stratum not receiving neurotoxic ART. Mean change from baseline in Gracely Pain Scale score for average pain was not different between LTG and placebo at the end of the maintenance phase in either stratum, but the slope of the change in Gracely Pain Scale score for average pain reflected greater improvement with LTG than with placebo in the stratum receiving neurotoxic ART (p = 0.004), as did the mean change from baseline scores on the Visual Analogue Scale for Pain Intensity and the McGill Pain Assessment Scale and patient and clinician ratings of global impression of change in pain (p ≤ 0.02). The incidence of adverse events, including rash, was similar between LTG and placebo. Conclusions: Lamotrigine was well-tolerated and effective for HIV-associated neuropathic pain in patients receiving neurotoxic antiretroviral therapy. Additional research is warranted to understand the differing response among patients receiving neurotoxic antiretroviral therapy compared with these not receiving neurotoxic antiretroviral therapy.

Original languageEnglish (US)
Pages (from-to)1508-1514
Number of pages7
JournalNeurology
Volume60
Issue number9
StatePublished - May 13 2003

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Placebos
HIV
Pain
Pain Measurement
Therapeutics
Maintenance
Painful Neuropathy
lamotrigine
Polyneuropathies
Neuralgia
Random Allocation
Exanthema
Double-Blind Method
Incidence
Research

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Simpson, D. M., McArthur, J. C., Olney, R., Clifford, D., So, Y., Ross, D., ... Vollmer, K. (2003). Lamotrigine for HIV-associated painful sensory neuropathies: A placebo-controlled trial. Neurology, 60(9), 1508-1514.

Lamotrigine for HIV-associated painful sensory neuropathies : A placebo-controlled trial. / Simpson, David M.; McArthur, Justin Charles; Olney, R.; Clifford, D.; So, Y.; Ross, D.; Baird, B. J.; Barrett, P.; Hammer, A. E.; Baker, R.; Bartt, R.; Becker, S.; Berger, J.; Brannagan, T.; Cohen, B.; Dorko, C.; Ellis, R.; Feinberg, D. M.; Goodkin, K.; Hall, C.; Kumar, P.; Marra, C.; Pollard, R.; Schifitto, G.; Tselis, A.; Vollmer, K.

In: Neurology, Vol. 60, No. 9, 13.05.2003, p. 1508-1514.

Research output: Contribution to journalArticle

Simpson, DM, McArthur, JC, Olney, R, Clifford, D, So, Y, Ross, D, Baird, BJ, Barrett, P, Hammer, AE, Baker, R, Bartt, R, Becker, S, Berger, J, Brannagan, T, Cohen, B, Dorko, C, Ellis, R, Feinberg, DM, Goodkin, K, Hall, C, Kumar, P, Marra, C, Pollard, R, Schifitto, G, Tselis, A & Vollmer, K 2003, 'Lamotrigine for HIV-associated painful sensory neuropathies: A placebo-controlled trial', Neurology, vol. 60, no. 9, pp. 1508-1514.
Simpson DM, McArthur JC, Olney R, Clifford D, So Y, Ross D et al. Lamotrigine for HIV-associated painful sensory neuropathies: A placebo-controlled trial. Neurology. 2003 May 13;60(9):1508-1514.
Simpson, David M. ; McArthur, Justin Charles ; Olney, R. ; Clifford, D. ; So, Y. ; Ross, D. ; Baird, B. J. ; Barrett, P. ; Hammer, A. E. ; Baker, R. ; Bartt, R. ; Becker, S. ; Berger, J. ; Brannagan, T. ; Cohen, B. ; Dorko, C. ; Ellis, R. ; Feinberg, D. M. ; Goodkin, K. ; Hall, C. ; Kumar, P. ; Marra, C. ; Pollard, R. ; Schifitto, G. ; Tselis, A. ; Vollmer, K. / Lamotrigine for HIV-associated painful sensory neuropathies : A placebo-controlled trial. In: Neurology. 2003 ; Vol. 60, No. 9. pp. 1508-1514.
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abstract = "Objective: To evaluate the efficacy and tolerability of lamotrigine (LTG) for the treatment of pain in HIVassociated sensory neuropathies. Methods: In a randomized, double-blind study, patients with HIV-associated distal sensory polyneuropathy (DSP) received LTG or placebo during a 7-week dose escalation phase followed by a 4-week maintenance phase. Randomization was stratified according to whether or not patients were currently using neurotoxic antiretroviral therapy (ART). Results: The number of patients randomized was 92 (62 LTG, 30 placebo) in the stratum receiving neurotoxic ART and 135 (88 LTG, 47 placebo) in the stratum not receiving neurotoxic ART. Mean change from baseline in Gracely Pain Scale score for average pain was not different between LTG and placebo at the end of the maintenance phase in either stratum, but the slope of the change in Gracely Pain Scale score for average pain reflected greater improvement with LTG than with placebo in the stratum receiving neurotoxic ART (p = 0.004), as did the mean change from baseline scores on the Visual Analogue Scale for Pain Intensity and the McGill Pain Assessment Scale and patient and clinician ratings of global impression of change in pain (p ≤ 0.02). The incidence of adverse events, including rash, was similar between LTG and placebo. Conclusions: Lamotrigine was well-tolerated and effective for HIV-associated neuropathic pain in patients receiving neurotoxic antiretroviral therapy. Additional research is warranted to understand the differing response among patients receiving neurotoxic antiretroviral therapy compared with these not receiving neurotoxic antiretroviral therapy.",
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T1 - Lamotrigine for HIV-associated painful sensory neuropathies

T2 - A placebo-controlled trial

AU - Simpson, David M.

AU - McArthur, Justin Charles

AU - Olney, R.

AU - Clifford, D.

AU - So, Y.

AU - Ross, D.

AU - Baird, B. J.

AU - Barrett, P.

AU - Hammer, A. E.

AU - Baker, R.

AU - Bartt, R.

AU - Becker, S.

AU - Berger, J.

AU - Brannagan, T.

AU - Cohen, B.

AU - Dorko, C.

AU - Ellis, R.

AU - Feinberg, D. M.

AU - Goodkin, K.

AU - Hall, C.

AU - Kumar, P.

AU - Marra, C.

AU - Pollard, R.

AU - Schifitto, G.

AU - Tselis, A.

AU - Vollmer, K.

PY - 2003/5/13

Y1 - 2003/5/13

N2 - Objective: To evaluate the efficacy and tolerability of lamotrigine (LTG) for the treatment of pain in HIVassociated sensory neuropathies. Methods: In a randomized, double-blind study, patients with HIV-associated distal sensory polyneuropathy (DSP) received LTG or placebo during a 7-week dose escalation phase followed by a 4-week maintenance phase. Randomization was stratified according to whether or not patients were currently using neurotoxic antiretroviral therapy (ART). Results: The number of patients randomized was 92 (62 LTG, 30 placebo) in the stratum receiving neurotoxic ART and 135 (88 LTG, 47 placebo) in the stratum not receiving neurotoxic ART. Mean change from baseline in Gracely Pain Scale score for average pain was not different between LTG and placebo at the end of the maintenance phase in either stratum, but the slope of the change in Gracely Pain Scale score for average pain reflected greater improvement with LTG than with placebo in the stratum receiving neurotoxic ART (p = 0.004), as did the mean change from baseline scores on the Visual Analogue Scale for Pain Intensity and the McGill Pain Assessment Scale and patient and clinician ratings of global impression of change in pain (p ≤ 0.02). The incidence of adverse events, including rash, was similar between LTG and placebo. Conclusions: Lamotrigine was well-tolerated and effective for HIV-associated neuropathic pain in patients receiving neurotoxic antiretroviral therapy. Additional research is warranted to understand the differing response among patients receiving neurotoxic antiretroviral therapy compared with these not receiving neurotoxic antiretroviral therapy.

AB - Objective: To evaluate the efficacy and tolerability of lamotrigine (LTG) for the treatment of pain in HIVassociated sensory neuropathies. Methods: In a randomized, double-blind study, patients with HIV-associated distal sensory polyneuropathy (DSP) received LTG or placebo during a 7-week dose escalation phase followed by a 4-week maintenance phase. Randomization was stratified according to whether or not patients were currently using neurotoxic antiretroviral therapy (ART). Results: The number of patients randomized was 92 (62 LTG, 30 placebo) in the stratum receiving neurotoxic ART and 135 (88 LTG, 47 placebo) in the stratum not receiving neurotoxic ART. Mean change from baseline in Gracely Pain Scale score for average pain was not different between LTG and placebo at the end of the maintenance phase in either stratum, but the slope of the change in Gracely Pain Scale score for average pain reflected greater improvement with LTG than with placebo in the stratum receiving neurotoxic ART (p = 0.004), as did the mean change from baseline scores on the Visual Analogue Scale for Pain Intensity and the McGill Pain Assessment Scale and patient and clinician ratings of global impression of change in pain (p ≤ 0.02). The incidence of adverse events, including rash, was similar between LTG and placebo. Conclusions: Lamotrigine was well-tolerated and effective for HIV-associated neuropathic pain in patients receiving neurotoxic antiretroviral therapy. Additional research is warranted to understand the differing response among patients receiving neurotoxic antiretroviral therapy compared with these not receiving neurotoxic antiretroviral therapy.

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