Study of efficacy and safety of erenumab in adult subjects with chronic migraine
- Conditions
- Health Condition 1: G437- Chronic migraine without aura
- Registration Number
- CTRI/2020/09/027647
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Signed informed consent must be obtained prior to participation in the study.
2. Adults � 18 to � 65 years of age upon entry into screening
3. History of at least 5 attacks of migraine without aura and/or migraine with visual, sensory, speech and/or language, retinal or brainstem aura according to the IHS Classification ICHD-3 based on medical records and/or patient self-report.
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. � 15 headache days of which � 8 headache days meet criteria as migraine days during the
baseline period based on the eDiary calculation
6. Demonstrated at least 80% compliance with the eDiary (e.g. must complete eDiary items
on at least 23 out of 28 days during the baseline period) based on the eDiary calculation
7. History of migraine (with or without aura) for � 12 months prior to screening according to
the IHS Classification (Tassorelli et al 2018) based on medical records and/or patient selfreport
1. Older than 50 years of age at migraine onset
2. History of cluster headache or hemiplegic migraine headache
3. Chronic migraine with continuous pain, in which the subject does not experience any pain
free periods (of any duration) during the 1 month prior to screening
4. Unable to differentiate migraine from other headaches
5. Taken an opioid and/or opioid-containing analgesic for any indication during more than
4 days within one month prior to the start of the baseline period or during the baseline period
6. History of seizure disorder or other significant neurological conditions other than
migraine.
7. History of malignancy of any organ system (other than localized basal cell carcinoma of
the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless
of whether there is evidence of local recurrence or metastases.
8. History or evidence of any other unstable or clinically significant medical condition, that
in the opinion of the investigator, would pose a risk to subject safety or interfere with the
study evaluation, procedures or completion
9. Human immunodeficiency virus (HIV) infection by history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in <br/ ><br>subjects with chronic migraineTimepoint: Change from baseline in monthly migraine <br/ ><br>days during the last 4 weeks of the 12-week <br/ ><br>treatment period
- Secondary Outcome Measures
Name Time Method