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A placebo-controlled, double-blind, randomized proof-of-concept study to evaluate the efficacy and tolerability of the CGRP receptor antibody erenumab in treating pain experienced by subjects with TN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | 140 mg Erenumab |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects classified as responders at the end of the evaluation period. | A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in mean average daily pain intensity score (mean ADP) assessed using the 11-point numerical rating scale (NRS) during the evaluation period (week 1-4) compared with baseline (weeks -4 to -1). Patients that are protocol violators, e.g., patients having to increase current medications or undergoes surgery in the evaluation period as well as pa-tients who drop out due to worsening of symptoms or side effects will be recorded as non-responders. | 4 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measures |
Due to word limitations not all secondary outcome measures were explaned in detail and/or registered. |
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Inclusion Criteria:
Exclusion Criteria:
Age ≥ 55 years with cessation of menses for 12 or more months, OR Age < 55 years but no spontaneous menses for at least 2 years, OR Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotro-pin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmeno-pausal range" for the laboratory involved. OR o Underwent bilateral oophorectomy OR o Underwent hysterectomy OR o Underwent bilateral salpingectomy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stine Maarbjerg, MD, PhD | Contact | 004538633525 | stine.maarbjerg@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lars Bendtsen, MD, Dr Med Sci | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center, Department of Neurology, Rigshospitalet - Glostrup | Recruiting | Glostrup Municipality | 2600 | Denmark |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C000605816 | erenumab |
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Placebo is saline
| Drug |
Saline |
|
| 4 weeks after randomization |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |