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Table 1 Visit schedule and methods

From: Botulinum neurotoxin type A in the treatment of classical Trigeminal Neuralgia (BoTN): study protocol for a randomized controlled trial

   First part: single blind Second part: double blind, randomized
Visit schedule and methods V-1 (Screening, 8 days before V0) V0 = open-label verum injection V1 (28 ± 3 days after V0) V2 = randomized, doubleblind intervention (84 ± 3 days after V0) V3 (28 ± 2 days after V2) V4 (84 ± 3 days after V2)
Patient’s consent X      
Inclusion/Exclusion criteria X      
Standardized, semi-structured patient history X X X X X X
SF-12 Questionnaire assessing life quality X X X X X X
ADS Questionnaire assessing depression X X X X X X
HIT-6 Questionnaire assessing pain severity X X X X X X
Neurological examination X   X X X X
Medical examination X   X X X X
Blood tests X      
Pain-evoked potentials   X X X X X
Randomization     X   
BT-A/Placebo injection   X (verum)   X (verum/placebo)   
Assessment of baseline TN frequency   X     
Assessment of therapy response    X   X  
Assessment of adverse events   X X X X X
Pseudonymization Patients are assigned to a screening number Screening numbers are assigned to randomization list
  1. ADS Allgemeine Depressionsskala: General Depression Scale, HIT-6 Headache Impact Test-6, SF-12 12-item short form questionnaire, TN trigeminal neuralgia