Study to assess the long-term safety and tolerability of erenumab in migraine patients
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Migraine prophylaxisMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2019-002201-22-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 640
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method