Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LBR-101 High Dose · 2 trials · 2 indications
A headache day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache of any severity or the participant used acute migraine medication (triptans and ergot compounds) to treat a headache. This calculation was defined as the change from baseline in the number of hours with headache of any severity during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or severe.
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
A migraine day was endorsed when at least 1 of the following situations occurred: 1) A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine, or 2) a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only one migraine criterion is missing, or 3) the participant used acute migraine medication (triptans and ergot compounds) to treat a headache of any duration, or 4) any of the above days preceded or followed by a day with a headache of any duration. This calculation was defined as the change from baseline in the number of headache days during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or severe.
Adverse events were rated based on the investigator's clinical judgment. Mild: awareness of a sign or symptom that was easily tolerated Moderate: sign or symptom intense enough to interfere with usual activity Severe: interfered significantly with ability to do work or usual activity
| Arm | Type | Description |
|---|---|---|
| LBR-101 High Dose | EXPERIMENTAL | Subcutaneous High Dose LBR-101 Administered Monthly x 3 |
| LBR-101 Low Dose | EXPERIMENTAL | Subcutaneous Low Dose LBR-101 Administered Monthly x 3 |
| Placebo | PLACEBO_COMPARATOR | Subcutaneous Placebo Administered Monthly x 3 |
| Name | Type | Description |
|---|---|---|
| LBR-101 High Dose | DRUG | Subcutaneously Administered LBR-101 Monthly x 3 |
| LBR-101 Low Dose | DRUG | Subcutaneously Administered LBR-101 Monthly x 3 |
| Placebo | DRUG | Subcutaneously Administered Placebo (Vehicle) Monthly x 3 |
Inclusion Criteria: * Males or females aged 18 to 65 years of age. * A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments. * Chronic migraine meet...
LBR-101 High Dose is an investigational small molecule being studied for the prevention of episodic migraine headache and chronic migraine. It is in Phase 2 clinical development and is not yet approved by the FDA. The drug is being developed by Teva Pharmaceutical Industries Limited.
LBR-101 High Dose is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its potential to reduce the frequency of migraine attacks in patients with episodic and chronic migraine.
LBR-101 High Dose is being developed by Teva Pharmaceutical Industries Limited, a company traded on the NYSE under the ticker TEVA. The drug is currently in Phase 2 clinical trials for migraine indications.
LBR-101 High Dose is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 2 trials have been completed, one in chronic migraine and one in high frequency episodic migraine.
LBR-101 High Dose has been studied in two completed Phase 2 trials. NCT02021773 assessed the drug in chronic migraine with 264 participants, and NCT02025556 assessed it in high frequency episodic migraine with 297 participants. Both trials were conducted in the United States.