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Table 1 Schedule of assessments throughout the study

From: Efficacy, safety, and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutation-related small fiber neuropathy: study protocol of a randomized controlled trial–the LENSS study

Protocol Activity

Screen

(Week -4-0)

Base-line/

Randomization

Titration

(Week 1-3)

Treatment

Period 1

(Week 4- 11)

Tapering

Week 12-13

Washout

Week 14-15

Titration

(Week 16-18)

Treatment

Period 2

(Week 19- 26)

Tapering

Week 27-28

Follow-up

Week 33

Clinic Visita

V1

V2

T1-2

V3

T3-T5

V4

T6

V5

T7-T8

V6

T9-T11

V7

T12

V8

Informed Consent

X

             

Inclusion/Exclusion criteria

X

             

Randomizationb

 

X

            

Medical History

X

             

Demography

X

             

Physical Examination (Full)

X

             

Physical Examination (Brief)

 

X

 

X

 

X

 

X

 

X

 

X

  

Weight and Height

X

             

Safety Laboratory Testsc

X

  

X

 

X

 

X

 

X

 

X

  

FSHd

X

             

HbA1c blood teste

X

             

12-lead ECG

X

  

X

 

X

 

X

 

X

 

X

  

BP (supine and standing) and PR

X

  

X

 

X

 

X

 

X

 

X

  

Daily Pain Diary (PI-NRS)f

 

X

 

X

Daily Sleep Interference Scale (DSIS)g

 

X

 

X

Neuropathic Pain Scale (NPS)

X

X

X

X

X

X

X

X

X

X

X

X

X

 

SFN-SIQ Questionnaire

X

X

X

X

X

X

X

X

X

X

X

X

X

 

Patient Global Impression of Change

 

X

X

X

X

X

X

X

X

X

X

X

X

 

SF-36

 

X

   

X

 

X

   

X

  

Adverse Event Monitoringh

 

X

 

X

Concomitant Medicationh

 

X

 

X

Dispense Study Medicationi

 

X

 

X

 

X

 

X

 

X

 

X

  

Retrieve Study Medication dispensed at previous study visit

   

X

 

X

 

X

 

X

 

X

 

X

Dispense Rescue Medication

 

X

 

X

 

X

 

X

 

X

 

X

  

Retrieve Rescue Medication dispensed at previous study visit

   

X

 

X

 

X

 

X

 

X

 

X

Dispense and instruct on Daily Pain Diaries

X

             

Retrieve Daily Pain Diary

X

X

 

X

 

X

 

X

 

X

 

X

 

X

Study medication compliance check

   

X

 

X

 

X

 

X

 

X

 

X

  1. BP; blood pressure, ECG; electrocardiogram, FSH; follicle-stimulating hormone, HbA1c; hemoglobin A1c, NPS; neuropathic pain scale, PI-NRS; pain intensity numerical rating scale, PR; pulse rate, SFN-SIQ; small fiber neuropathy symptom inventory questionnaire, T; telephone call, V; visit, SF-36; short form 36
  2. a. Visit/study activity window can be ± 2 days
  3. b. Subjects will be randomized provided they fulfill study selection criteria
  4. c. Safety laboratory tests include hematology and clinical chemistry
  5. d. Females who are 45-60 years of age who are amenorrheic for at least 1 year
  6. e. HbA1c test to be performed in subjects with diabetes and at investigator’s discretion for subjects who do not have a clinical diagnosis of diabetes but present with hyperglycemia on safety lab tests
  7. f. Daily Pain Diary (PI-NRS) to be completed by subject twice daily (morning and evening pain scores) and reviewed by study personnel at scheduled clinic visits
  8. g. Daily Sleep Interference Scale (DSIS) to be completed by subject once daily on waking starting morning after Screening Visit (V1)
  9. h. Adverse events and concomitant medication will be monitored during the entire study
  10. I. Full dosing instructions will be provided and the first dose of study medication will be taken on the evening of the SECOND study visit (V2)
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Trials

ISSN: 1745-6215