Table 2.
Visit Schedule
| Pre-Randomisation | Week 3/Day 21 (+/- 3 days) | Week 12 (+/- 7 days) | Month 12 (+/- 7 days) |
|---|---|---|---|
| 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 | |||