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Table 2 Schedule of enrolment, interventions, and assessments

From: Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial

  Enrollment Treatment period 1   Treatment period 2 Close-out
  Before Eligibility Screening
Visit 1c
Visit 2
Visit 3
2 weeks after V2
Visit 4
6 weeks after V2
4 weeks
Visit 5 Visit 6
2 weeks after V5
Visit 7
6 weeks after V5
Follow-up Visit 8
4 weeks after V7
Timeline (days)   0/-28 0 14 42 70 70 84 112 140
Informed consenta X          
Inclusion/exclusion criteria   X         
Medical history, including demographics & medications   X         
Documentation of physiotherapy/speech therapy   X Xb X X   X X X X
Neurological examination   X         
Blood tests   Xd    Xd   Xd   Xd  
Randomization    X        
Dispensing of trial drug    X     X    
Return of trial drug      X     X  
Compliance check     X X    X X  
Patient questionnaires
(EQ-5D-5 L, BDI-II, FSS)
   X X X   X X X X
Ataxia rating scale: SARA   X Xb X X   X X X X
Ataxia rating scale: SCAFI    X X X   X X X X
Documentation of (S)AEs   X Xb X X   X X X X
Documentation of concomitant medication (drug history)    X X X   X X X X
  1. A delay of -3 and +5 days is acceptable for visits 2 and 5, for all other visits a delay of ± 5 days is acceptable
  2. aprior to first study-specific intervention and allocation
  3. bIf visit 1 and visit 2 take place at the same time, the ataxia rating scale (SARA), documentation of physiotherapy/speech therapy and documentation of (S)AE are assessed only once
  4. cIf patients are on medication due to cerebellar symptoms at visit 1, a 4-week wash-out (screening period) prior to randomization at visit 2 is required (adherence will again be checked before randomization at V2). Otherwise, visit 1 and visit 2 coincide
  5. dincl. negative pregnancy test for women of childbearing potential