Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: A randomised controlled trial

Lancet

Volumn 355, Issue 9219, 2000, Pages 1949-1954

  Lees, Kennedy R ^a   Asplund, Kjell ^b   Carolei, Antonio ^c   Davis, Stephen M ^d   Diener, Hans Christop ^e   Kaste, Markku ^f   Orgogozo, Jean Marc ^g   Whitehead, John ^h  

^a WESTERN INFIRMARY   (United Kingdom)

^b UMEÅ UNIVERSITY HOSPITAL   (Sweden)

^c Ospedale S Maria di Collemaggio   (Italy)

^d ROYAL MELBOURNE HOSPITAL   (Australia)

^e UNIVERSITY OF DUISBURG ESSEN   (Germany)

^f HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^g HÔPITAL PELLEGRIN   (France)

^h UNIVERSITY OF READING   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

GAVESTINEL; GLYCINE RECEPTOR ANTAGONIST;

ADULT; AGED; ARTICLE; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; NEUROPROTECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT;

EID: 0034600485     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(00)02326-6     Document Type: Article

References (32)

1. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 333:1995;1581-1587.
2. McCulloch J. Ischaemic brain damage. prevention with competitive and non-competitive antagonists of N-methyl-D-aspartate receptors Arzneimittelforschung. 41:1991;319-324.
3. Warner D.S., Martin H., Ludwig P., McAllister A., Keana J.F.W., Weber E. In vivo models of cerebral ischemia. effects of parenterally administered NMDA receptor glycine site antagonists J Cereb Blood Flow Metab. 15:1995;188-196.
4. Yao H., Ibayashi S., Nakane H., Cai H., Uchimura H., Fujishima M. AMPA receptor antagonist, YM90K, reduces infarct volume in thrombotic distal middle cerebral artery occlusion in spontaneously hypertensive rats. Brain Res. 753:1997;80-85.
5. Di Fabio R., Cugola A., Donati D.et al. Identification and pharmacological characterization of GV150526, a novel glycine antagonist as a potent neuroprotective agent. Drugs Future. 23:1998;61-69.
6. Dyker A.G., Lees K.R. The safety and tolerability of GV150526 (a glycine site antagonist at the NMDA receptor) in patients with acute stroke. two double blind, randomised, placebo controlled, parallel group, ascending dose studies Stroke. 30:1999;986-992.
7. Lees K.R., Lavelle J.F., Cunha L.et al. Glycine antagonist (GV150526) in acute stroke: a double-blind placebo-controlled phase II trial. Cerebrovasc Dis. 1999;2000. (in press).
8. Phase II studies of the glycine antagonist GV150526 in acute stroke: the North American Experience. Stroke. 31:2000;358-365.
9. Sacco R.L., Phillips S.J., Haley E.C., Levin B. Efficacy and safety of GV150526 in acute stroke: results of the GAIN Americas trial (glycine antagonist in neuroprotection). Neurology. 54:2000;A87-A88.
10. Mahoney F.I., Barthel D.W. Functional evaluation. the Barthel Index Maryland Med J. 14:1965;61-65.
11. Brott T., Adams H.P., Olinger C.P.et al. Measurements of acute cerebral infarction. a clinical examination scale Stroke. 20:1989;864-870.
12. Lyden P.D., Brott T.G., Tilley B.et al. Improved reliability of the NIH stroke scale using video training. Stroke. 25:1994;2220-2226.
13. Rankin J. Cerebral vascular accidents in patients over the age of 60, II. prognosis Scot Med J. 2:1957;200-215.
14. Van Swieten J.C., Koudstaal P.J., Visser M.C., Schouten H.J.A., van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 19:1988;604-607.
15. Generalized efficacy of t-PA for acute stroke. Stroke. 28:1998;2119-2125.
16. Tilley B.C., Marler J., Geller N.L.et al. Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke t-PA Stroke Trial. Stroke. 27:1998;2136-2142.
17. Wahlgren N.G., Ranasinha K.W., Rosolacci T.et al. Clomethiazole Acute Stroke Study (CLASS): results of a randomized, controlled trial of clomethiazole versus placebo in 1360 acute stroke patients. Stroke. 30:1999;21-28.
18. Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke. 30:1999;2752-2758.
19. Dewar D., Yam P., McCulloch J. Drug development for stroke. importance of protecting cerebral white matter Eur J Pharmacol. 375:1999;41-50.
20. Wester P., Sandström E., Hoke F. The neuroprotectant, GV150526, penetrates the cerebrospinal fluid following treatment of acute stroke. Cerebrovasc Dis. 10:2000;76. (abstr).
21. Hoke J.F., Dyker A.G., Barnaby R., Lees K.R. Pharmacokinetics of GV150526 following multiple dosing in patients with acute stroke. Eur J Clin Pharmacol. 55:2000;867-872.
22. Sulter G., Steen C., De Keyser J. Use of the Barthel index and modified Rankin scale in acute stroke trials. Stroke. 30:1999;1538-1541.
23. Granger C.V., Dewis L.S., Peters N.C., Sherwood C.C., Barrett J.E. Stroke rehabilitation. analysis of repeated Barthel index measures Arch Phys Med Rehab. 60:1979;14-17.
24. Grotta J. Lubeluzole treatment of acute ischemic stroke. Stroke. 28:1997;2338-2346.
25. Diener H.C. Multinational randomised controlled trial of lubeluzole in acute ischaemic stroke. Cerebrovasc Dis. 8:1998;172-181.
26. Hacke W., Kaste M., Fieschi C.et al. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischemic stroke (ECASS II). Lancet. 352:1998;1245-1251.
27. Whitehead J. Application of sequential methods to a phase III clinical trial in stroke. Drug Inf J. 27:1993;733-740.
28. Heiss W.D., Thiel A., Grond M., Graf R. Which targets are relevant for therapy of acute ischemic stroke? Stroke. 30:1999;1486-1489.
29. Baron J. Mapping the ischaemic penumbra with PET. implications for acute stroke treatment Cerebrovasc Dis. 9:1999;193-201.
30. Davis S.M., Albers G.W., Diener H.C., Lees K.R., Norris J. Termination of acute stroke studies involving selfotel treatment. Lancet. 349:1997;332.
31. Davis S.M., Lees K.R., Albers G.W.et al. Selfotel in acute ischemic stroke. possible neurotoxic effects of an NMDA antagonist Stroke. 31:2000;347-354.
32. De Keyser J., Sulter G., Luiten P.G. Clinical trials with neuroprotective drugs in acute ischaemic stroke: are we doing the right thing? Trends Neurosci. 22:1999;535-540.