Author
|
Year
|
Country
|
Type of study
|
Size
|
Sex Males/Females
|
Age (mean)
|
Type of ALS
|
Drug
|
Dose
|
Administration
|
Time of treatment
|
Follow-up
|
Assessment measures
|
Result
|
Conclusion
|
Plaitakis et al.(1414 Plaitakis A, Mandeli J, Smith J, Yahr MD. Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. Lancet. 1988;1(8593):1015-8. http://dx.doi.org/10.1016/S0140-6736(88)91841-7. PMid:2896868. http://dx.doi.org/10.1016/S0140-6736(88)...
)
|
1988 |
USA |
Randomized, placebo controlled, double-blind |
22 |
D = 10/1 P = 9/2 |
D = 48.5 P = 53.7 |
|
Branched-chain amino acids |
3.0 g/L-leucine, 2.0 g/L-isoleucine, 1.6 g/L-valine |
Powder ingested 4 times a day between meals |
1 year |
The sample was assessed in months 0, 3, 6, 9, 12 |
Bulbar scale by Plaitakis et al.(1414 Plaitakis A, Mandeli J, Smith J, Yahr MD. Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. Lancet. 1988;1(8593):1015-8. http://dx.doi.org/10.1016/S0140-6736(88)91841-7. PMid:2896868. http://dx.doi.org/10.1016/S0140-6736(88)...
)
|
D - 0 month: score 12.5; 3rd month: 10; 6th month: 9; 9th month: 7; 12th month: 8; P - 0 month: score 13.2; 3rd month: 11; 6th month: 9; 9th month: 9; 12th month: 6. |
No statistically significant difference was found |
Askmark et al.(1515 Askmark H, Aquilonius SM, Gillberg PG, Liedholm LJ, Stålberg E, Wuopio R. A pilot trial of dextromethorphan in amyotrophic lateral sclerosis. J Neurol Neurosurg Psychiatry. 1993 Fev;56(2):197-200. http://dx.doi.org/10.1136/jnnp.56.2.197. PMid:8437010. http://dx.doi.org/10.1136/jnnp.56.2.197...
)
|
1993 |
Sweden |
Clinical trial, double-blind, crossed, 2nd phase open clinical trial |
14 |
5/9 |
62.07 |
B (5) UMN (1) LMN (8) |
Dextromethorphan |
150 mg/day/ 2nd phase 300 mg/day |
Tablet 3 (30 mg) + 1 (60 mg) 4 x day; 2nd phase: 3 (60 mg) + 1 (120 mg) |
12 weeks; 2nd phase 3 and 6 months |
The sample was assessed in weeks 12, 16, and 28; 2nd phase, 0, 16, and 28 |
Bulbar scale by Plaitakis et al.(1414 Plaitakis A, Mandeli J, Smith J, Yahr MD. Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. Lancet. 1988;1(8593):1015-8. http://dx.doi.org/10.1016/S0140-6736(88)91841-7. PMid:2896868. http://dx.doi.org/10.1016/S0140-6736(88)...
)
|
n = 10 concluded the treatment – 3 decreased score, 7 stable; 2nd phase – 3 months n = 8, 6 months n = 6, with unchanged scores. |
There were no effects on the parameters assessed |
Ryberg et al.(1616 Ryberg H, Askmark H, Persson LI. A double-blind randomized clinical trial in amyotrophic lateral sclerosis using lamotrigine: effects on CSF glutamate, aspartate, branched-chain amino acid levels and clinical parameters. Acta Neurol Scand. 2003 Jul;108(1):1-8. http://dx.doi.org/10.1034/j.1600-0404.2003.00111.x. PMid:12807386. http://dx.doi.org/10.1034/j.1600-0404.20...
)
|
2003 |
United Kingdom |
Double-blind, placebo-controlled, crossed |
39 |
D = 15/5 P = 9/10 |
D = 53.6 P = 59.2 |
D = 2 (B), 18 (L) P = 3 (B), 16 (L) |
Lamotrigine |
300 mg/day |
100-mg tablet taken 3x a day |
16 weeks |
The sample was assessed in weeks 0, 22, and 44 |
Bulbar scale by Plaitakis et al.(1414 Plaitakis A, Mandeli J, Smith J, Yahr MD. Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. Lancet. 1988;1(8593):1015-8. http://dx.doi.org/10.1016/S0140-6736(88)91841-7. PMid:2896868. http://dx.doi.org/10.1016/S0140-6736(88)...
)
|
D 0.35 (n = 17) - P 1.2 (n = 13) p-value = 0.42 (0.017). |
There were no effects on the parameters assessed |
Meininger et al.(1717 Meininger V, Bensimon G, Bradley WR, Brooks B, Douillet P, Eisen AA, et al. Efficacy and safety of xaliproden in amyotrophic lateral sclerosis: results of two phase III trials. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004 Jun;5(2):107-17. http://dx.doi.org/10.1080/14660820410019602. PMid:15204012. http://dx.doi.org/10.1080/14660820410019...
)
|
2004 |
France |
Multicentric, multinational, randomized, double-blind, placebo-controlled |
867 |
D 1mg = 176/117 D 2mg = 185/103 P = 168/118 |
D 1mg = 55.5 D 2mg = 56.8 P = 55.2 |
D 1mg= 73 (B), 220 (L) D 2mg = 69 (B), 219 (L) |
Xaliproden |
1 to 2 mg |
|
18 months /568 days |
The sample was assessed at the beginning and end of treatment |
ALSFRS-R swallowing subscale |
Decreased 25%, P = 0.013 and 17%, P> 0.087 for 1 mg and 2 mg. |
No statistically significant difference was found |
Green et al.(1818 Green JR, Allison KM, Cordella C, Richburg BD, Pattee GL, Berry JD, et al. Additional evidence for a therapeutic effect of dextromethorphan/quinidine on bulbar motor function in patients with amyotrophic lateral sclerosis: a quantitative speech analysis. Br J Clin Pharmacol. 2018;84(12):2849-56. http://dx.doi.org/10.1111/bcp.13745. PMid:30152872. http://dx.doi.org/10.1111/bcp.13745...
)
|
2018 |
USA |
Multicentric, randomized, double-blind, crossed |
10 |
7/3 |
57.5 |
(B) 5 (L) |
Dextromethorphan/Quinidine |
20 to 10 mg |
30 days for active treatment and placebo |
The sample was assessed at the beginning and end of treatment |
30 days for active treatment and placebo. |
ALSFRS-R speech subscale |
Active phase: Pre-treatment 2.20 Post-treatment 2.40 p-value 0.50; Placebo: Pre-treatment 2.50 Post-treatment 2.3 p-value 0.50 |
No statistically significant difference was found |