Presentation Number: LB 7 Publishing Title: Flame: A Multicenter

Presentation Number: LB 7
Publishing Title: Flame: A Multicenter Randomized Double-blind Placebo-controlled Trial With Fluoxetine In
Motor Recovery Of Patients With Acute Ischaemic Stroke.
Author Block: Francois Chollet, Jean Tardy, Jean Francois Albucher, Catherine Arnaud, Emilie Berard, CHU
de Toulouse, Hop Purpan, Toulouse, France; Yannick Bejot, CHU de Dijon, Dijon, France; Sandrine Deltour,
Hop La Salpetriere, Paris, France; Catherine Lamy, Hop Sainte Anne, Paris, France; Assia Jaillard, CHU de
Grenoble, Grenoble, France; Philippe Niclot, Ctr Hospier de Pontoise, Pontoise, France; Benoit Guillon, CHU
de Nantes, Nantes, France; Philippe Marque, Jeremie Pariente, Claire Thalamas, CHU de Toulouse, Hop
Purpan, Toulouse, France; Isabelle Loubinoux, INSERM U825, Toulouse, France
Abstract Body:
Background: hemiplegia and hemiparesia are the most common deficits caused by stroke. Some animal
studies and few clinical small-sized trials suggest that Fluoxetin enhances motor recovery but its clinical
efficacy is uncertain.
Participants and methods: in a double-blind, placebo-controlled trial, 118 patients with ischaemic stroke from 9
stroke centers in France were randomly assigned to a three-month treatment of 20mg o d Fluoxetin or placebo
starting 5 to 10 days after the stroke onset. All the patients had physiotherapy. The primary outcome measure
was the variation of Fugl-Meyer motor scale (FMMS) between D0 and D90. Secondary outcomes assessed
NIHSS, Rankin scale and MADRS variations between D0 and D90.
Results: baseline mean FMMSS was 13.4 (+/-8.8) and 17.1 (+/-11.7) in the placebo and Fluoxetin group
respectively. FMMS progression at D 90 was significantly greater in the Fluoxetin group (+36.4 +/-21.3) than in
the placebo group (+21.9 +/-16.7) (p= 0.003). NIHSS and MADRS showed no differences while motor part of
NIHSS showed a greater improvement in the Fluoxetin (-5.2 +/-2.4) than in the placebo group (-4 +/-2.5)
(p=0.016). The number of independent patients (Rankin: 1-2) was significantly higher in the Fluoxetin group at
D90 than in the placebo group (26.3%(N=15) vs 8.9%(N=5); p=0.015).
Conclusion: in patients with ischaemic stroke and severe motor deficit, the early prescription of a of 20mg o.d
Fluoxetin associated with physiotherapy, enhances motor recovery after three months and significantly
reduces the number of dependant patients with Rankin 3-5.
Registration: ClinicalTrials.gov, number NCT00657163
Author Disclosure Block: F. Chollet: None. J. Tardy: None. J. Albucher: None. C. Arnaud: None. E.
Berard: None. Y. Bejot: None. S. Deltour: None. C. Lamy: None. A. Jaillard: None. P. Niclot: None. B.
Guillon: None. P. Marque: None. J. Pariente: None. C. Thalamas: None. I. Loubinoux: None.