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Publication Number
US-11471434-B2
Publication Date
2022-10-18
Expiration Date
Abstract
A first aspect of the invention relates to leucine, acetyl-leucine, or a pharmaceutically acceptable salt thereof, for use in treating or preventing a migraine, or one or more symptoms associated therewith. A second aspect of the invention relates to a method of treating or preventing a migraine, or one or more symptoms associated therewith, in a subject, said method comprising administering to the subject a therapeutically or prophylactically effective amount of leucine, acetyl-leucine, or a pharmaceutically acceptable salt thereof.
Core Innovation
The invention provides leucine and acetyl-leucine, including pharmaceutically acceptable salts, for treating or preventing migraine and one or more symptoms associated therewith. The methods are directed to migraine that is not associated with vertigo or symptoms of vertigo, and the described symptom endpoints include headache, aura and visual aura, nausea and vomiting, photophobia and phonophobia, and sensory and systemic symptoms.
The problem addressed is the need for treating or preventing migraine and associated symptoms, including prophylaxis of aura and management across migraine subtypes. The disclosure frames the approach in terms of treating and preventing migraine, while defining symptom endpoints used to evaluate therapeutic effect.
The disclosed rationale and supportive evidence include in vitro data with NPC CHO cells, including NPC1-null, in which leucine and acetyl-leucine reduce lysosomal volume. Representative clinical use is supported by case-study examples of Tanganil® (acetyl-DL-leucine), including reported symptom improvements and relapse upon discontinuation.
Claims Coverage
The independent claim family is centered on a single independent claim directed to treating or preventing migraine, or symptoms associated therewith, using acetyl-leucine or a pharmaceutically acceptable salt, with the limitation that the migraine is not associated with vertigo or symptoms of vertigo. The coverage is refined by dependent claim features that narrow the treated migraine subtype and specify acetyl-leucine form and dosing constraints.
Treatment of migraine not associated with vertigo by acetyl-leucine
Administering a therapeutically or prophylactically effective amount of acetyl-leucine, or a pharmaceutically acceptable salt thereof, to treat or prevent a migraine, or one or more symptoms associated therewith, in a subject, wherein the migraine is not associated with vertigo or symptoms of vertigo.
Symptom-aligned migraine management
Using acetyl-leucine, or a pharmaceutically acceptable salt, to reduce the frequency of, alleviate, or eliminate migraine-related symptoms such as headache and various sensory, gastrointestinal, and systemic complaints.
Vestibular migraine embodiment
Carrying out the method such that the migraine being treated is a vestibular migraine.
Hemiplegic migraine embodiment
Further defining the method such that the migraine being treated is a hemiplegic migraine.
Racemic acetyl-leucine stereochemical form
Using acetyl-leucine in racemic form.
Daily dose range for acetyl-leucine
Administering acetyl-leucine at a daily dose ranging from about 500 mg to about 15 g per day.
Overall, the claim coverage focuses on acetyl-leucine, or pharmaceutically acceptable salts, as a therapeutic or prophylactic treatment for migraine and associated symptoms, excluding migraines associated with vertigo symptoms, with dependent coverage narrowing to particular migraine subtypes and specifying acetyl-leucine form and daily dosing constraints.
Stated Advantages
Treating or preventing migraine and one or more symptoms associated therewith.
Reducing the frequency of, alleviating, or eliminating migraine-related symptoms including headache and various sensory, gastrointestinal, and systemic complaints.
Providing prophylaxis of aura as described in the disclosure.
Documented Applications
Treating or preventing migraine and migraine-associated symptoms in a subject where the migraine is not associated with vertigo or symptoms of vertigo.
Treating prophylaxis of aura and migraine symptoms across multiple migraine subtypes described in the disclosure, including vestibular migraine, hemiplegic migraine, basilar-type migraine, retinal migraine, chronic migraine, episodic migraine, acute migraine, and prodromal/postdromal symptoms.
Tanganil® (acetyl-DL-leucine) use in case-study examples, with reported symptom improvement and relapse upon discontinuation.
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