Migraine prophylaxis MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aimovig
Product Name: Aimovig
Product Code: AMG334
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ERENUMAB
CAS Number: 1582205-90-0
Current Sponsor code
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is capable of understanding the nature, significance and implications of the clinical trial. - Adults =18 years of age upon entry into screening - Earliest time point for inclusion to this open-label study is 26 weeks after randomization to trial CAMG334ADE01: a)Subjects who completed visit V199 in trial CAMG334ADE01 have to wait additional 2 weeks for down-titration of topiramate (doses 75 and 100 mg) and total elimination for topiramate (equals 26 weeks after randomization) b)Subjects who discontinued their participation in CAMG334ADE01 before V199 have to wait until the planned V199 visit date and additional 2 weeks (26 weeks after randomization). - Subjects who are deemed by the investigator to benefit from erenumab therapy Other protocol-defined inclusion criteria may apply. 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 608 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: - Patients who had to terminate the trial CAMG334ADE01 due to a protocol violation or due to a safety event. - Use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the Open-label Treatment Epoch. This exclusion criteria does not apply to erenumab or topiramate administered within clinical trial CAMG334ADE01 - Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab. - Use of the following for any indication one month prior to the start of the Open-label Treatment Epoch: a. Opioid- or butalbital-containing analgesics =4 days/month Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety of 70 and 140 mg erenumab in patients with episodic migraine;Secondary Objective: To evaluate the long-term tolerability of 70 and 140 mg erenumab in patients with episodic migraine;Primary end point(s): Exposure adjusted incidence rate of AE during Open-label Treatment Epoch per 100 subject years;Timepoint(s) of evaluation of this end point: End of Open-Label Treatment Epoch (Week 128) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients discontinuing open-label Treatment Epoch due to AE • Proportion of patients discontinuing open-label Treatment Epoch due to non-AE reasons ;Timepoint(s) of evaluation of this end point: End of Open-Label Treatment Epoch (Week 128) | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed