Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis

R. G. Miller, D. H. Moore, D. F. Gelinas, V. Dronsky, M. Mendoza, R. J. Barohn, W. Bryan, J. Ravits, E. Yuen, H. Neville, S. Ringel, M. Bromberg, J. Petajan, A. A. Amato, C. Jackson, W. Johnson, R. Mandler, P. Bosch, B. Smith, M. GravesMark A Ross, Eric James Sorenson, P. Kelkar, G. Parry, R. Olney

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Abstract

Background: Preclinical and clinical studies of gabapentin in patients with ALS led the authors to undertake a phase III randomized clinical trial. Methods: Patients were randomly assigned, in a double-blinded fashion, to receive oral gabapentin 3,600 mg or placebo daily for 9 months. The primary outcome measure was the average rate of decline in isometric arm muscle strength for those with two or more evaluations. Results: Two hundred four patients enrolled, 196 had two or more evaluations, and 128 patients completed the study. The mean rate of decline of the arm muscle strength was not significantly different between the groups. Moreover, there was no beneficial effect upon the rate of decline of other secondary measures (vital capacity, survival, ALS functional rating scale, timed walking) nor was there any symptomatic benefit. In fact, analysis of the combined data from the phase II and III trials revealed a significantly more rapid decline of forced vital capacity in patients treated with gabapentin. Conclusion: These data provide no evidence of a beneficial effect of gabapentin on disease progression or symptoms in patients with ALS.

Original languageEnglish (US)
Pages (from-to)843-848
Number of pages6
JournalNeurology
Volume56
Issue number7
StatePublished - Apr 10 2001

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Amyotrophic Lateral Sclerosis
Vital Capacity
Muscle Strength
Phase III Clinical Trials
Walking
Disease Progression
gabapentin
Randomized Controlled Trials
Placebos
Outcome Assessment (Health Care)
Survival

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Miller, R. G., Moore, D. H., Gelinas, D. F., Dronsky, V., Mendoza, M., Barohn, R. J., ... Olney, R. (2001). Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis. Neurology, 56(7), 843-848.

Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis. / Miller, R. G.; Moore, D. H.; Gelinas, D. F.; Dronsky, V.; Mendoza, M.; Barohn, R. J.; Bryan, W.; Ravits, J.; Yuen, E.; Neville, H.; Ringel, S.; Bromberg, M.; Petajan, J.; Amato, A. A.; Jackson, C.; Johnson, W.; Mandler, R.; Bosch, P.; Smith, B.; Graves, M.; Ross, Mark A; Sorenson, Eric James; Kelkar, P.; Parry, G.; Olney, R.

In: Neurology, Vol. 56, No. 7, 10.04.2001, p. 843-848.

Research output: Contribution to journalArticle

Miller, RG, Moore, DH, Gelinas, DF, Dronsky, V, Mendoza, M, Barohn, RJ, Bryan, W, Ravits, J, Yuen, E, Neville, H, Ringel, S, Bromberg, M, Petajan, J, Amato, AA, Jackson, C, Johnson, W, Mandler, R, Bosch, P, Smith, B, Graves, M, Ross, MA, Sorenson, EJ, Kelkar, P, Parry, G & Olney, R 2001, 'Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis', Neurology, vol. 56, no. 7, pp. 843-848.
Miller RG, Moore DH, Gelinas DF, Dronsky V, Mendoza M, Barohn RJ et al. Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis. Neurology. 2001 Apr 10;56(7):843-848.
Miller, R. G. ; Moore, D. H. ; Gelinas, D. F. ; Dronsky, V. ; Mendoza, M. ; Barohn, R. J. ; Bryan, W. ; Ravits, J. ; Yuen, E. ; Neville, H. ; Ringel, S. ; Bromberg, M. ; Petajan, J. ; Amato, A. A. ; Jackson, C. ; Johnson, W. ; Mandler, R. ; Bosch, P. ; Smith, B. ; Graves, M. ; Ross, Mark A ; Sorenson, Eric James ; Kelkar, P. ; Parry, G. ; Olney, R. / Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis. In: Neurology. 2001 ; Vol. 56, No. 7. pp. 843-848.
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abstract = "Background: Preclinical and clinical studies of gabapentin in patients with ALS led the authors to undertake a phase III randomized clinical trial. Methods: Patients were randomly assigned, in a double-blinded fashion, to receive oral gabapentin 3,600 mg or placebo daily for 9 months. The primary outcome measure was the average rate of decline in isometric arm muscle strength for those with two or more evaluations. Results: Two hundred four patients enrolled, 196 had two or more evaluations, and 128 patients completed the study. The mean rate of decline of the arm muscle strength was not significantly different between the groups. Moreover, there was no beneficial effect upon the rate of decline of other secondary measures (vital capacity, survival, ALS functional rating scale, timed walking) nor was there any symptomatic benefit. In fact, analysis of the combined data from the phase II and III trials revealed a significantly more rapid decline of forced vital capacity in patients treated with gabapentin. Conclusion: These data provide no evidence of a beneficial effect of gabapentin on disease progression or symptoms in patients with ALS.",
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T1 - Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis

AU - Miller, R. G.

AU - Moore, D. H.

AU - Gelinas, D. F.

AU - Dronsky, V.

AU - Mendoza, M.

AU - Barohn, R. J.

AU - Bryan, W.

AU - Ravits, J.

AU - Yuen, E.

AU - Neville, H.

AU - Ringel, S.

AU - Bromberg, M.

AU - Petajan, J.

AU - Amato, A. A.

AU - Jackson, C.

AU - Johnson, W.

AU - Mandler, R.

AU - Bosch, P.

AU - Smith, B.

AU - Graves, M.

AU - Ross, Mark A

AU - Sorenson, Eric James

AU - Kelkar, P.

AU - Parry, G.

AU - Olney, R.

PY - 2001/4/10

Y1 - 2001/4/10

N2 - Background: Preclinical and clinical studies of gabapentin in patients with ALS led the authors to undertake a phase III randomized clinical trial. Methods: Patients were randomly assigned, in a double-blinded fashion, to receive oral gabapentin 3,600 mg or placebo daily for 9 months. The primary outcome measure was the average rate of decline in isometric arm muscle strength for those with two or more evaluations. Results: Two hundred four patients enrolled, 196 had two or more evaluations, and 128 patients completed the study. The mean rate of decline of the arm muscle strength was not significantly different between the groups. Moreover, there was no beneficial effect upon the rate of decline of other secondary measures (vital capacity, survival, ALS functional rating scale, timed walking) nor was there any symptomatic benefit. In fact, analysis of the combined data from the phase II and III trials revealed a significantly more rapid decline of forced vital capacity in patients treated with gabapentin. Conclusion: These data provide no evidence of a beneficial effect of gabapentin on disease progression or symptoms in patients with ALS.

AB - Background: Preclinical and clinical studies of gabapentin in patients with ALS led the authors to undertake a phase III randomized clinical trial. Methods: Patients were randomly assigned, in a double-blinded fashion, to receive oral gabapentin 3,600 mg or placebo daily for 9 months. The primary outcome measure was the average rate of decline in isometric arm muscle strength for those with two or more evaluations. Results: Two hundred four patients enrolled, 196 had two or more evaluations, and 128 patients completed the study. The mean rate of decline of the arm muscle strength was not significantly different between the groups. Moreover, there was no beneficial effect upon the rate of decline of other secondary measures (vital capacity, survival, ALS functional rating scale, timed walking) nor was there any symptomatic benefit. In fact, analysis of the combined data from the phase II and III trials revealed a significantly more rapid decline of forced vital capacity in patients treated with gabapentin. Conclusion: These data provide no evidence of a beneficial effect of gabapentin on disease progression or symptoms in patients with ALS.

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