Trigeminal neuralgia MedDRA version: 20.0 Level: PT Classification code 10044652 Term: Trigeminal neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aimovig
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ERENUMAB
Other descriptive name: Aimovig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Dansk Hovedpine Center, Neurologisk Klinik, Rigshospitalet - Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A diagnosis of primary TN (idiopathic or classical) according to criteria of The Interna-tional Classification of Headache Disorders 3rd edition. • Age between 18 and 85 years. • Subjects must have a minimum mean of 3 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 3 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 ran-domized). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • 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 subject’s and investigator’s knowledge. • Severe psychiatric disease. • Anamnestic or clinical symptoms of any kind that are deemed relevant for study partic-ipation 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 and evaluation periods (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 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmen-opausal 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the proportion of subjects classified as responders at the evaluation period (i.e. week 1-4). 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 in-crease current medications or who will undergo surgery in the evaluation period as well as patients who drop out due to worsening of symptoms or side effects will be recorded as non-responders.;Secondary Objective: To evaluate the proportion of: - Subjects reaching a reduction of =50% and =75% respectively in mean ADP during the evaluation period compared with baseline. - Subjects with a response in mean daily number of paroxysms at evaluation period (i.e. reduction of = 30% in mean of daily number of paroxysms at evaluation period compared with baseline). - Subjects with a Patient Global Impression of Change (PGIC) scale response at evaluation period ( i.e. has a PGIC response of “much improved” or “very much improved” at week 4.) To evaluate the change from baseline to week 4 in the active and placebo group respectively: - Mean ADP. - Number of paroxysms. - The Penn Facial Pain Scale-Revised (PENN-FPS-R) score. To evaluate the percentage of drop-outs in active and placebo group caused by: - Increased intake of TN-medication. - Side-effects. To evaluate the percentage of subjects with side-effects registered in weeks 1-4 during treatment compared with placebo. ;Primary end point(s): 1. To evaluate the proportion of subjects classified as responders at the evaluation period (i.e. week 1-4). a. A subject who meets the following criterion will be classified as a responder: i. Has a reduction of = 30% in mean average daily pain intensity score (mean ADP) assessed using the 11-point numer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: 1. To evaluate the proportion of subjects reaching =50% reduction in mean ADP during the evaluation period (week 1-4) compared with baseline (week -4 to -1). 2. To evaluate the proportion of subjects reaching =75% reduction in mean ADP during the evaluation period (week 1-4) compared with baseline (week -4 to -1). 3. The proportion of subjects with a response in number of paroxysms at evaluation period. a. A subject who meets the following criterion will be classified as a responder: i. Has a reduction of = 30% in mean of daily number of paroxysms during the evaluation period (week 1-4) compared with baseline (week -4 to -1). The change/reduction in mean number of paroxysms from baseline to evaluation period is cal-culated as following: (mean number of paroxysms of evaluation period) – (mean number of paroxysm of baseline period). If this reduction is = 30% the given subjects is classified as a responder. 4. Proportion of subjects with a Patient Global Impression of Change (PGIC) scale re-sponse at evaluation period. A subject who meets the following criterion will be classi-fied as a responder: has a PGIC response of “much improved” or “very much improved” at week 4. 5. Change from baseline to week 4 in mean ADP in active and placebo group. This is calculated as following: (mean ADP of evaluation period) – (mean ADP of baseline pe-riod) and is a measure for the absolute change in mean ADP. 6. Change from baseline to week 4 in number of paroxysms in active and placebo group. This is calculated as following: (mean number of paroxysms of evaluation period) – (mean number of paroxysms of baseline period) and is a measure for the absolute change in mean number of paroxysms. 7. Change from baseline to week 4 in the Penn Facial Pain Scale-Revised (PENN-FPS-R) score. 8. Drop-outs caused by increased intake of TN-medication in active group compared to placebo. 9. Drop-outs caused by side-effect in active group compared to placebo. | — |
Countries
Denmark
Contacts
Public ContactLars Bendtsen
Danish Headache Center
Outcome results
None listed