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Neurophysiological double-blind trial of a botulinum neurotoxin type a free of complexing proteins . OBJECTIVE Safety and efficacy of botulinum neurotoxin type A preparation NT 201 ( Xeomin , Merz Pharmaceuticals GmbH , Frankfurt am Main , Germany ) were investigated over 52 weeks in a double-blind , randomized trial with 32 male volunteers . METHODS Electroneurographic assessments with surface electrodes were performed after single injections of NT 201 ( 2 , 4 , 16 , or 32 units ) into the extensor digitorum brevis ( EDB ) muscle and the same dose ( Botox ; Allergan Pharmaceuticals ( Ireland ) Ltd. Westport , Ireland ) into the contralateral EDB . RESULTS All NT 201 and BTXCo doses achieved a statistically significant reduction of the compound muscle action potential M-wave amplitude in the EDB muscle . At week 4 , the highest dose was statistically significantly more effective than the lowest dose ( NT 201 , P = 0.019 ; 95 % confidence interval , 0.195-1.370 ; and BTXCo , P = 0.002 ; 95 % confidence interval , 0.309-1.167 ) . Duration of effect was dose dependent . The mean values of compound muscle action potential M-wave amplitudes in the adjacent muscles ( abductor digiti quinti and abductor hallucis ) were above the predefined threshold of effect , indicating that there was no relevant diffusion-induced reduction of muscle activity . NT 201 and BTXCo were well tolerated . CONCLUSIONS NT 201 is effective and safe in inducing the desired paretic effect .
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Intervention_Pharmacological
botulinum neurotoxin type a
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Intervention_Pharmacological
botulinum neurotoxin type A preparation NT 201
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Intervention_Pharmacological
single injections of NT 201
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Intervention_Pharmacological
extensor digitorum brevis
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Intervention_Pharmacological
same dose
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Intervention_Pharmacological
into the contralateral EDB
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Intervention_Pharmacological
NT 201 and BTXCo
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Intervention_Pharmacological
NT 201
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Intervention_Pharmacological
BTXCo
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Intervention_Pharmacological
NT 201
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Outcome_Other
Safety
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Outcome_Other
efficacy
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Outcome_Other
Electroneurographic
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Outcome_Physical
reduction of the compound muscle action potential M-wave amplitude
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Outcome_Other
effective
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Outcome_Other
Duration of effect
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Outcome_Physical
mean values of compound muscle action potential M-wave amplitudes in the adjacent muscles
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Outcome_Physical
muscle activity
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Outcome_Other
tolerated
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Participant_Condition
randomized trial with
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Participant_Sample-size
32
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Participant_Sex
male
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Participant_Condition
volunteers .