Table 2 |
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|
Visit Schedule |
|||
|
Pre-Randomisation |
Week 3/Day 21 (+/- 3 days) |
Week 12 (+/- 7 days) |
Month 12 (+/- 7 days) |
|
|
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|
A detailed list of drugs and other agents that might interact with lithium will be provided to volunteers and to their general practitioners, together with a list of 24 hour emergency contact numbers. |
Dose monitoring (Li levels) |
ALS Interventions |
ALS Interventions |
|
Informed consent |
Biochemistry |
ALSFRS-R |
ALSFRS-R |
|
Registration/Demographics |
Urine Pregnancy Test Adverse Events |
EQ-5D |
EQ-5D |
|
SVC |
Concomitant medications |
HADS |
HADS |
|
ALS History |
Physical Exam (inc vital signs) |
Physical Exam (inc vital signs) |
|
|
ALS Interventions |
Dose monitoring (Li levels) |
ECG |
|
|
Medical HistoryNeurological Exam |
Haematology |
Dose monitoring (Li levels) |
|
|
Inclusion/Exclusion Criteria Physical Exam (inc vital signs) |
Biochemistry |
Haematology |
|
|
ALSFRS-R |
Urine Pregnancy Test Adverse Events |
Biochemistry |
|
|
EQ-5D |
Concomitant medications |
TFTs |
|
|
HADS |
Trial Medication Log |
Urine Pregnancy Test Adverse Events |
|
|
ECG |
Drug Dispensing & Returns |
Concomitant medications |
|
|
Dose monitoring (Li levels) |
Trial Medication Log |
||
|
Haematology |
Drug Dispensing & Returns |
||
|
Biochemistry |
|||
|
Thyroid Function Tests |
|||
|
Urine Pregnancy Test |
|||
|
Concomitant Medications |
|||
|
Adverse Events |
|||
|
Drug Dispensing |
|||
|
Trial Medication Log |
|||
|
|
|||
|
Week 1/Day 7 (+/- 3 days) |
Week 4/Day 28 (+/- 3 days) |
Month 6 (+/- 7 days) |
Month 15 (+/- 7 days) |
|
|
|||
|
Dose monitoring (Li levels) |
Dose monitoring (Li levels) |
ALS Interventions |
ALS Interventions |
|
Biochemistry |
Haematology |
ALSFRS-R |
ALSFRS-R |
|
Urine Pregnancy Test |
Biochemistry |
EQ-5D |
EQ-5D |
|
Adverse Events |
Urine Pregnancy Test Adverse Events |
HADS |
HADS |
|
Concomitant medications |
Concomitant medications |
Physical Exam (inc vital signs) |
Physical Exam (inc vital signs) |
|
Trial Medication Log |
ECG |
Dose monitoring (Li levels) |
|
|
Drug Dispensing & Returns |
Dose monitoring (Li levels) |
Haematology |
|
|
Haematology |
Biochemistry |
||
|
Biochemistry |
Urine Pregnancy Test Adverse Events |
||
|
TFTs |
Concomitant medications |
||
|
Urine Pregnancy Test Adverse Events |
Trial Medication Log |
||
|
Concomitant medications |
Drug Dispensing & Returns |
||
|
Trial Medication Log |
|||
|
Drug Dispensing & Returns |
|||
|
|
|||
|
Week 2/Day 14 (+/- 3 days) |
Week 8 (+/- 3 days) |
Month 9 (+/- 7 days) |
Month 18/Week 77 (+ 7 days) |
|
|
|||
|
Dose monitoring (Li levels) |
Dose monitoring (Li levels) |
ALS Interventions |
ALS Interventions |
|
Biochemistry |
Haematology |
ALSFRS-R |
ALSFRS-R |
|
Urine Pregnancy Test Adverse Events |
Biochemistry |
EQ-5D |
EQ-5D |
|
Concomitant medications |
Urine Pregnancy Test Adverse Events |
HADS |
HADS |
|
Concomitant medications |
Physical Exam (inc vital signs) |
Physical Exam (inc vital signs) |
|
|
Trial Medication Log |
Dose monitoring (Li levels) |
ECG |
|
|
Drug Dispensing & Returns |
Haematology |
Dose monitoring (Li levels) |
|
|
Biochemistry |
Haematology |
||
|
Urine Pregnancy Test Adverse Events |
Biochemistry |
||
|
Concomitant medications |
TFT's |
||
|
Trial Medication Log |
Urine Pregnancy Test Adverse Events |
||
|
Drug Dispensing & Returns |
Concomitant medications |
||
|
Trial Medication Log |
|||
|
Drug Returns |
|||
|
Unscheduled Visits |
|||
|
|
|||
|
Al-Chalabi et al. BMC Neurology 2011 11:111 doi:10.1186/1471-2377-11-111 |
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