Approval Probability
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Adjusted LOA
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Also known as LBR-101 IV, LBR-101 High Dose
LBR-101 · 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 is an investigational small molecule being studied for migraine prevention, specifically in chronic migraine and episodic migraine headache. It has been evaluated in Phase 2 clinical trials in adults with these conditions. It is not approved for any indication and remains in clinical development.
LBR-101 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating LBR-101 in migraine indications.
LBR-101 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in high frequency episodic migraine and one in chronic migraine. No Phase 3 trials have been reported, and the drug is not approved.
LBR-101 has been studied in two completed Phase 2 trials: NCT02025556, a multicenter assessment in high frequency episodic migraine with 297 participants, and NCT02021773, an assessment in chronic migraine with 264 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States.
Yes. LBR-101 IV and LBR-101 High Dose are alternative names for LBR-101, the same investigational compound developed by Teva Pharmaceutical Industries Limited for migraine prevention. Searches using any of these names refer to the same drug asset.