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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
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Trials

ISSN: 1745-6215