provigil for fatigue study showed no improvement in fatigue

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provigil for fatigue study showed no improvement in fatigue

Postby Cece » Thu Nov 17, 2011 10:21 am

http://www.neurology.org/content/64/7/1139.short
Modafinil for fatigue in MS

A randomized placebo-controlled double-blind study

B. Stankoff, MD, PhD*,
E. Waubant, MD, PhD*,
C. Confavreux, MD,
G. Edan, MD,
M. Debouverie, MD,
L. Rumbach, MD,
T. Moreau, MD, PhD,
J. Pelletier, MD, PhD,
C. Lubetzki, MD, PhD,
M. Clanet, MD, PhD and
French Modafinil Study Group†

+ Author Affiliations

From the Fédération de Neurologie (Drs. Stankoff and Lubetzki), Centre d’Investigation Clinique (Drs. Stankoff and Waubant), Hôpital de la Salpêtrière, AP-HP, Paris, France; Services de Neurologie, CHU de Lyon (Dr. Confavreux), Rennes (Dr. Edan), Nancy (Dr. Debouverie), Besançon (Dr. Rumbach), Dijon (Dr. Moreau), and Marseille (Dr. Pelletier); Fédération de Neurologie (Dr. Clanet), CHU de Toulouse, France; and UCSF MS Center (Dr. Waubant), San Francisco, CA.

Address correspondence and reprint requests to Dr. Bruno Stankoff, Centre d’Investigation Clinique, Hôpital de la Salpêtrière, 47 boulevard de l’Hôpital, 75651 Paris cedex 13, France; e-mail: bruno.stankoff@psl.ap-hop-paris.fr


Abstract

Objective: To assess whether modafinil, a wakefulness-promoting agent, is useful for fatigue in patients with multiple sclerosis (MS).

Methods: Patients with MS with stable disability, and a baseline score of 45 or more on the Modified Fatigue Impact Scale (MFIS), were eligible for the 5-week randomized, double-blind, placebo-controlled, parallel group study. The initial daily dose of modafinil was 200 mg for 1 week. Depending on tolerance, the dose was increased by 100 mg every week up to 400 mg/day and remained unchanged between day 21 and day 35. The primary outcome variable was the change of MFIS score at day 35.

Results: A total of 115 patients with MS were enrolled in the study and in the intention to treat analysis. The mean MFIS score at baseline was 63 ± 9 in the placebo group and 63 ± 10 in the modafinil group. MFIS scores improved between day 0 and day 35 in both placebo-treated and modafinil-treated groups, but no significant difference was detected between the two groups. There was no major safety concern.

Conclusions: There was no improvement of fatigue in patients with multiple sclerosis treated with modafinil vs placebo according to the Modified Fatigue Impact Scale.

Kinda surprising. I've found provigil helpful with my fatigue, although it doesn't take it away, it is more manageable.
I used to use 100 mg provigil every day, and 200 in the summer, but now it's 50 mg nuvigil occasional use, since CCSVI treatment helped with my fatigue.
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Re: provigil for fatigue study showed no improvement in fati

Postby ErikaSlovakia » Thu Nov 17, 2011 10:57 am

I am not surprised. Provigil doesn´t help my fatigue.
I started to take it about 2 years ago. I keep trying sometimes but really - it does nothing for me :-(
Erika
Aug. 7, 09 Doppler Ultras. in Poland, left Jugul. valve problem, RRMS since 1996, now SPMS,
- Nov.3,09: one stent in the left jug. vein in Katowice, Poland, LDN, never on DMDs
- Jan. 19, 11: control venography in Katowice - negative but I feel worse
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Re: provigil for fatigue study showed no improvement in fati

Postby CureOrBust » Fri Nov 18, 2011 1:06 am

I have found that physically it does less, but mentally I may be willing to drive myself a little harder. This would make sense in that placebo may trick people into driving themselves a little further. I like the stuff, but take it sparingly, and usually around 100-300mg in a single day, and not normally on consecutive days.
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Re: provigil for fatigue study showed no improvement in fati

Postby Wendigo » Fri Nov 18, 2011 7:13 am

Provigil "amped" me up but I'd still be yawning. I would feel like a car with the accelerator pedal stuck down but brakes on. Not fun. Stopped taking it.
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Re: provigil for fatigue study showed no improvement in fati

Postby CureOrBust » Fri Nov 18, 2011 4:07 pm

Yeah, its weird, once I took it while I was still in bed to help get me out of bed, but I still had no problem laying there.
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Re: provigil for fatigue study showed no improvement in fati

Postby ssmme » Sat Nov 19, 2011 1:18 pm

Ha ha ha - Cureorbust - you made me chuckle. :-))
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Re: provigil for fatigue study showed no improvement in fati

Postby Bear2 » Sun Nov 20, 2011 6:56 am

Provigil worked fantastic for me. I would alway drift off while driving. I drive alot, 30-40K per year for work. Most trips are 2-3 hours. It got to the point were I would have to stop and get out walk around and even nap.

I started taking Provigil and it worked great. No more drifting off while driving and it did not affect sleeping at night. All was great until my insurance decided it would not cover it anymore and I had to switch to Nuvigil. Both drugs are from same company and they made Nuvigil due to Provigil is due to go patent. Nuvigil is simular but 1/2 as effective. Need to take Nuvigil 2x per day.

Hopefully when Provigil goes off patent the price will full due to generics.
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