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1. WO2020115490 - TRAITEMENT DE SYMPTÔMES D'UNE LÉSION CÉRÉBRALE TRAUMATIQUE

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CLAIMS

1. A method for treating a symptom of traumatic brain injury (TBI), the method comprising administering a therapeutically-effective amount of a botulinum neurotoxin to a subject diagnosed to be in need thereof.

2. A composition for use in a method of treating a symptom of traumatic brain injury, the composition comprising a therapeutically-effective amount of a botulinum neurotoxin.

3. The method or composition for use according to claim 1 or claim 2, wherein the administration is local administration to the subject’s head.

4. The method or composition for use according to any one of the preceding claims, wherein the botulinum neurotoxin is administered in a single dose.

5. The method or composition for use according any one of the preceding claims, wherein the botulinum neurotoxin is administered subcutaneously.

6. The method or composition for use according to any one of the preceding claims, wherein the botulinum neurotoxin is administered pre-injury.

7. The method or composition for use according to any one of the preceding claims, wherein the botulinum neurotoxin is administered up to 4 days pre-injury.

8. The method or composition for use according to any one of the preceding claims, wherein the botulinum neurotoxin is administered between 1 -3 days pre-injury; optionally wherein the botulinum neurotoxin is administered 3 days pre-injury.

9. The method or use according to any one of the preceding claims, wherein the treatment is effected at a site that is peripheral to the site of administration; preferably wherein the administration is local administration to the subject’s head.

10. The method or composition for use according to any one of the preceding claims, wherein the botulinum neurotoxin is administered within 48 hours following injury; and/or wherein the botulinum neurotoxin is administered within 2 hours following injury; and/or wherein the botulinum neurotoxin is administered immediately following injury.

1 1 . The method or composition for use according to any one of the preceding claims, wherein the botulinum neurotoxin is administered at least about an hour following injury.

12. The method or composition for use according to any one of the preceding claims, wherein:

(a) the botulinum neurotoxin is administered at least about 2 hours following injury;

(b) the botulinum neurotoxin is administered at least about 6 hours following injury;

(c) the botulinum neurotoxin is administered at least about 12 hours following injury;

(d) the botulinum neurotoxin is administered at least about 24 hours following injury;

(e) the botulinum neurotoxin is administered at least about 48 hours following injury; and/or

(f) the botulinum neurotoxin is administered 2 to 72 hours following injury.

13. The method or composition for use according to any one of the preceding claims, wherein the symptom is one or more selected from temporary loss of consciousness, headache, sensitivity to light, sensitivity to noise, nausea, vomiting, lack of motor coordination, dizziness, light headedness, difficulty balancing, blurred vision or tired eyes, ringing in the ears, bad taste in the mouth, fatigue or lethargy, changes in sleep patterns, abnormality in learning and memory, impulsivity, emotional reactivity, mood swings, depression, or emotional blunting; optionally wherein the symptom is a headache or sensitivity to light.

14. The method or use according to any one of the preceding claims, wherein the symptom is chronic sensitivity to light, sound, stress and/or fatigue.

15. The method or use according to any one of the preceding claims, wherein the symptom is chronic sensitivity to light.

16. The method or composition for use according to any one of the preceding claims, wherein the amount of botulinum neurotoxin administered is between 20-70 units, optionally wherein the amount of botulinum neurotoxin administered is about 50 units.

17. The method or composition for use according to any one of the preceding claims, wherein:

(a) the amount of botulinum neurotoxin administered is less than about 30 units per kilogram of the total body weight of the subject;

(b) the botulinum neurotoxin is administered parenterally;

(c) the botulinum neurotoxin is administered through a suture of the skull of the subject;

(d) the botulinum neurotoxin has at least about 50%, 60%, 70%, 80%, 90%, 95%, 97%, 98%, or 99% sequence identity to the amino acid sequence of a botulinum neurotoxin of type A; or type A1 ; or type A2; or type A3; or type A4; or type B; or ty[e C; or type C1 ; or type D; or type E; or type F; or type G;

(e) the botulinum neurotoxin is: botulinum neurotoxin type A; botulinum neurotoxin type A1 ; botulinum neurotoxin type A2; botulinum neurotoxin type A3; botulinum neurotoxin type A4; botulinum neurotoxin type B; botulinum neurotoxin type C; botulinum neurotoxin type C1 ; botulinum neurotoxin type D; botulinum neurotoxin type E; botulinum neurotoxin type F; or botulinum neurotoxin type G, optionally wherein the botulinum neurotoxin is botulinum neurotoxin type A;

(f) the botulinum neurotoxin is DYSPORT®;

(g) the method further comprises measuring the severity of the symptom of the traumatic brain injury, optionally wherein the amount of botulinum neurotoxin administered is determined based in part on the level of severity of the symptom of traumatic brain injury;

(h) the method further comprises measuring the severity of the traumatic brain injury, optionally wherein the amount of botulinum neurotoxin administered is determined based in part on the level of severity of the traumatic brain injury;

(i) the amount of botulinum neurotoxin administered is determined based in part on the weight of the subject;

(j) the amount of botulinum neurotoxin administered is determined based in part on whether the subject has previously experienced traumatic brain injury;

(k) the amount of botulinum neurotoxin administered is determined based in part on the amount of time that has elapsed following injury;

(L) the composition further comprises a diluent, optionally wherein the diluent comprises a lyophilized powder, and optionally wherein the composition is formed by reconstituting lyophilized powder comprising botulinum neurotoxin; and/or

(m)the composition further comprises an excipient, optionally wherein the excipient is: a filler, a binder, a disintegrant, an anti-adherent, a solvent, a buffering agent, a preservative, or a humectant.

18. The method or composition for use according to any one of the preceding claims, the method further comprising:

(a) measuring the subject’s response to the administration of botulinum toxin; and/or

(b) measuring a dosing regimen for botulinum neurotoxin based on the subject’s response to a previous administration thereof, optionally wherein a subsequent administration of botulinum neurotoxin is based on the dosing regimen determined.

19. The method or composition for use according to any one of the preceding claims, further comprising recording the subject’s response to an administration of botulinum neurotoxin, optionally wherein the subject’s response is recorded on a first computer device and is accessed on a second computer device.

20. The method or composition for use according to claim 19, wherein the subject’s response is recorded into a software program that is configured to receive the information, and/or further comprising storing the subject’s response in a database.

21 . The method or composition for use according to any one of the preceding claims, the method further comprising determining whether the subject has or is likely to develop a symptom of traumatic brain injury before administering the botulinum neurotoxin.

22. The method or composition for use according to claim 21 , wherein the step of determining whether the subject has or is likely to develop a symptom of traumatic brain injury comprises measuring the level of a biomarker in the blood of the subject, the level being indicative of whether the subject has or is likely to develop the symptoms of traumatic brain injury, optionally wherein the biomarker is: ubiquitin carboxy-terminal hydrolase L1 , glial fibrillary acidic protein and calcitonin gene related peptide, TNF-a, or NF-L.