Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tafenoquine · 4 trials · 4 indications
The Multidimensional Fatigue Inventory (MFI) is a 20-item, patient-reported scale. designed to evaluate five dimensions of fatigue: general fatigue (items 1, 5, 12, 16), physical fatigue (items (items 2, 8, 14, 20), reduced motivation (items 3, 6, 10, 17), reduced activity (items 4, 9, 15, 18), and mental fatigue (items 7, 11, 13, 19) (Smets-1995). Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). This scale has been used to assess treatment outcomes in patients with chronic fatigue syndrome, women with fibromyalgia, Parkinson's disease, patients undergoing anti-cancer treatment, and the impact of fatigue on the quality of life in rheumatoid arthritis. Total scale score, and each of the 5 subscales scores will be calculated. MFI subscales are scored by summing four items, each has five possible responses giving a range of possible scores from 4 to 20.
Time to sustained clinical resolution of all the following symptoms of babesiosis: sweats, joint aches, cough, loss of appetite, muscle aches, headache, chills or shivering, feeling hot or feverish, nausea, fatigue (low energy or tiredness), and vomiting. The time to achieve sustained clinical resolution will be the date when patients first self-report a 7-day period without these symptoms relative to the start of tafenoquine or placebo treatment.
Clinical recovery from COVID-19 symptoms was defined as: temperature \< or equal to 37.7 degrees Celsius (surface by infra-red or oral), respiratory rate \< or equal to 24/minute on room air, shortness of breath is absent on a patient-report scale, and cough is mild or absent on a patient-reported scale.
Number of Participants with One or More protocol-defined serious ophthalmic safety event (SOSE) assessed by retinal changes from baseline using SD-OCT and qFAF. SOSE is assessed by significant retinal changes from baseline using SD-OCT and qFAF.
| Arm | Type | Description |
|---|---|---|
| Tafenoquine | EXPERIMENTAL | Tafenoquine (2 x 100 mg tablets) will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89. |
| Group 1 | ACTIVE_COMPARATOR | TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4 |
| Group 2 | PLACEBO_COMPARATOR | Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4 |
| Placebo | PLACEBO_COMPARATOR | Placebo two tablets 1x/day on Days 1,2,3 and 10 |
| Tafenoquine 200 mg (2 x 100 mg tablets) | ACTIVE_COMPARATOR | Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks |
| Name | Type | Description |
|---|---|---|
| Tafenoquine 100mg | DRUG | Tafenoquine |
| Tafenoquine | DRUG | Oral Tafenoquine |
| Placebo | OTHER | Placebo |
| Tafenoquine Oral Tablet | DRUG | Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10. |
Inclusion Criteria: * Male or female, aged ≥ 18 years * Severe disabling fatigue * Have at least one common symptom of babesiosis * Have laboratory evidence of exposure to babesia in the last 12 months * Able and willing to give written informed consent * Able and willing to perform all study asses...