Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia

NCT04054024 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: H-19011013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Secondary outcome measures

  4 weeks after randomization

Study Arms (2)

Active drug

ACTIVE COMPARATOR

Drug: Erenumab

Placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Erenumab DRUG

140 mg Erenumab

Active drug

Placebos DRUG

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of primary TN (idiopathic or classical) according to criteria of The Interna-tional Classification of Headache Disorders 3rd edition (1).
• Age between 18 and 85 years.
• Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 7-day screening phase to enter the baseline phase.
• Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 4-week baseline phase to enter the treatment phase (to be randomized).
• Fertile women must use safe contraceptives and present with a negative u-HCG at visit 1. Safe contraceptives are defined as intra-uterine devices, contraceptive pills or implants and surgical sterilization.

You may not qualify if:

• Significant cardiovascular and cerebrovascular disease such as ischemic heart disease, previous myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions.
• Language difficulties.
• Poor compliance, i.e. unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the sub-ject's and investigator's knowledge.
• Severe psychiatric disease.
• Anamnestic or clinical symptoms of any kind that are deemed relevant for study partici-pation by the physician who examines the patient.
• Taking any TN-medication, where the prescribed daily dose has changed within 2 weeks prior to the baseline period (refer to section 6.4 for the list of these medications).
• Pregnant or breastfeeding, or is a female expecting to conceive during the study, includ-ing through 4 weeks after treatment.
• Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide - males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:
• 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.
• Known sensitivity to any component of erenumab.
• Member of investigational site staff or relative of the investigator.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center, Department of Neurology, Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

erenumab

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Lars Bendtsen, MD, Dr Med Sci

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stine Maarbjerg, MD, PhD

CONTACT

004538633525; stine.maarbjerg@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo is saline
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: October 28, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

DK (1)