Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

JRCT ID: jRCT2080225076

Registered date:18/02/2020

Basic Information

• Recruitment status: recruiting
• Health condition(s) or Problem(s) studied: Migraine
• Date of first enrollment: 05/09/2019
• Target sample size: 286
• Countries of recruitment: United States,Belgium,Canada,Colombia,Finland,Germany,Hungary,Italy,Poland,Puerto Rico,Russian Federation,United Kingdom
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Erenumab
INN of investigational material : Erenumab
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for Investigational material : Weight-based injections of erenumab Dose 1 or Dose 2 will be administered subcutaneously monthly during the 24 week double-blind phase.

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Placebo will be administered subcutaneously monthly during the 24 week double-blind treatment period.

Outcome(s)

Primary Outcome

efficacy
1. Change from baseline in monthly migraine days (MMDs) [ Time Frame: Baseline through week 12 of the double blind treatment phase ]
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).

Secondary Outcome

efficacy
1. Change in monthly headache days from baseline [ Time Frame: Baseline through week 12 of the double blind treatment phase ]
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)
2. Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline [ Time Frame: Baseline through week 12 of the double blind treatment phase ]
To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).
3. Change in monthly migraine days (MMDs) from baseline to the average of the first 3 months [ Time Frame: Baseline through week 12 of the double blind treatment phase ]
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the double-blind treatment period (DBTP).
4. Change in monthly migraine days (MMDs) from baseline to the average of the first 6 months [ Time Frame: Completion of double blind treatment phase at 24 weeks ]
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the 6 month (week 1 through week 24) double-blind treatment period (DBTP).
5. Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale) [ Time Frame: Baseline through week 12 of the double blind treatment phase ]
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP). This will be measured in an electronic diary (eDiary) with a visual analogue scale.
6. Change from baseline in migraine-related disability and productivity [ Time Frame: Baseline through week 12 of the double blind treatment phase ]
To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified Pediatric Migraine Disability Assessment Questionnaire (modified PedMIDAS) to month 3 of the double-blind treatment period (DBTP).

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 17age old
• Gender: Both

Include criteria

1. Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study.
2. Subject's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
3. History of migraine (with or without aura) for >= 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013)
ICHD-3 specifications for pediatric migraine (subjects aged less than 18 years), should be considered for the diagnosis of migraine.
4. History of >= 15 headache days per month of which >= 8 headache days were assessed by the subject as migraine days per month in each of the 3 months prior to screening.
5. Migraine frequency: greater than or equal to 8 migraine days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration.
6. Headache frequency of greater than or equal to 15 headache days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration.
7. Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if more than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase).

Exclude criteria

1. History of cluster headache or hemiplegic migraine headache.
2. Chronic migraine with continuous pain, in which the subject does not have any pain free periods (of any duration) during the 1 month prior to screening.
3. No therapeutic response with greater than 3 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.
4. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
5. History of major psychiatric disorder. Subjects with anxiety disorder and/or mild major depressive disorder (Patient Health Questionnaire Modified for Adolescents [PHQ-A] score 9) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months before the start of the baseline phase.

Related Information

• Primary Sponsor: Amgen K.K.
• Secondary ID(s): NCT03832998,JapicCTI-205171