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Also known as Galcanezumab
Galcanezumab Prefilled Syringe · 1 trial · 1 indication
This is a recently developed and validated outcome measure for vestibular migraine from the investigators. It has been shown to be highly reliable and valid, and responsive to treatment changes. At this point, it is the only disease specific outcome measure for vestibular migraine. Scores are between 0 and 100, with 100 indicating higher levels of disease related suffering.
| Arm | Type | Description |
|---|---|---|
| Galcanezumab | EXPERIMENTAL | The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab. |
| Placebo | PLACEBO_COMPARATOR | The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo. |
| Name | Type | Description |
|---|---|---|
| Galcanezumab Prefilled Syringe | DRUG | Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes. |
| Placebo | DRUG | Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes. |
Inclusion Criteria: 1. Male or female aged 18 to 75 years of age at Study Visit 1. 2. Documentation of a vestibular migraine or probable vestibular migraine diagnosis according to the following criteria determined by the Barany Society: * Vestibular migraine * A: At least 5 episodes with ...
Galcanezumab is a monoclonal antibody being developed for the treatment of migraine and cluster headache. It is studied in episodic migraine, chronic migraine, and episodic and chronic cluster headache. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
Galcanezumab is a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), a protein involved in pain transmission. By binding to CGRP, it is designed to prevent migraine attacks. The drug is being developed by Eli Lilly and Company for neurological conditions.
Galcanezumab is developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug is being studied for migraine and cluster headache indications and is currently in Phase 3 clinical trials.
Galcanezumab is in Phase 3 clinical development. It has completed multiple Phase 3 trials for migraine, including studies in Japanese participants and in treatment-resistant migraine. The drug is investigational and has not received FDA approval.
Galcanezumab has been studied in several clinical trials, including NCT02614287, a safety study in migraine patients, and NCT02959190, a Phase 3 study in Japanese participants with migraine. Another trial, NCT03559257, evaluated the drug in adults with treatment-resistant migraine. All trials are completed.
Yes, Galcanezumab is also known as LY2951742. Clinical trials have used the name LY2951742, such as NCT02959177, which studied the drug in Japanese participants with episodic migraine. Both names refer to the same investigational monoclonal antibody.