Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03971071) looked at erenumab — a preventive migraine injection — in people who were overusing acute headache medications (a condition sometimes called "medication overuse headache," or MOH). A total of 620 adults took part in the main double-blind phase, split roughly equally into three groups: one receiving a placebo (dummy injection), one receiving a 70 mg dose of erenumab, and one receiving a 140 mg dose. Participants were tracked over six months to see whether their pattern of medication use changed. After the double-blind phase, 587 participants continued into an open-label phase where everyone received erenumab. The primary thing the trial measured was how many participants no longer met the criteria for medication overuse headache by the end of month six. The reported data shows that, out of roughly 206–207 people per group, 102 in the placebo group, 117 in the 70 mg group, and 134 in the 140 mg group reached that point. The trial also measured how many days per month participants used acute headache medications. The reported data shows average reductions of about 6.6 days per month for the placebo group, 7.8 days for the 70 mg group, and 9.4 days for the 140 mg group, compared to where each group started. On a separate measure — sustained remission from medication overuse headache at both the three-month and six-month marks — the reported figures were 73 participants in the placebo group, 96 in the 70 mg group, and 119 in the 140 mg group. The trial also tracked participants' scores on a questionnaire about how migraines affected their physical functioning and everyday activities (scored 0–100, where higher means greater burden). The reported data shows reductions in physical impairment scores of about 8.5 points (placebo), 11.8 points (70 mg), and 10.6 points (140 mg), and reductions in everyday activity impact scores of about 10.9 points (placebo), 13.5 points (70 mg), and 13.3 points (140 mg). Regarding unwanted events during the trial, the reported data shows that 130 out of 206 placebo participants, 139 out of 207 in the 70 mg group, and 142 out of 207 in the 140 mg group experienced at least one treatment-emergent adverse event during the double-blind phase; in the open-label phase, 178 out of 291 in the 70 mg group and 182 out of 296 in the 140 mg group did so. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 39283627) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Migraine Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older
- You have been diagnosed with migraine (with or without aura) for at least 12 months before joining
- You have had chronic migraine for at least 6 months before joining
- You are currently diagnosed with medication overuse headache (a condition where taking pain relief too often causes more headaches)
- You have tried at least one preventive migraine treatment in the past that did not work for you, caused side effects, or was poorly tolerated
- During the 4-week diary tracking period, you had at least 14 headache days, of which at least 8 were migraine days
- During the 4-week diary period, you used certain acute headache medications too frequently (for example, pain relievers on 15 or more days, or triptans/opioids on 10 or more days)
- You used acute headache medication at least 2 days per week during weeks where enough diary entries were recorded
- You completed the daily electronic diary on at least 23 out of 28 days during the tracking period
Who may not be able to join:
- Your migraines first started after age 50, or your chronic migraine began after age 65
- You have a history of hemiplegic migraine, cluster headaches, or certain other specific headache conditions
- You currently have another type of headache disorder (other than medication overuse headache)
- You have already tried more than 3 different categories of preventive migraine treatments with no benefit from any of them
- You changed the dose or frequency of a preventive migraine medication within 2 months before the tracking period started
- You received botulinum toxin (such as Botox) injections in the head or neck within 4 months before joining
- You have previously been treated with a type of preventive medication called an anti-CGRP therapy
- You have a serious or unstable health condition that could put you at risk or affect the study results, in the opinion of the study doctor
- You have used illegal recreational drugs in the 12 months before joining, based on records, self-report, or a positive drug test
- You changed or plan to change the dose of any medication that might prevent migraines during or after the tracking period
- You are pregnant, breastfeeding, or unwilling to use an acceptable method of contraception if required
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: MD, Amgen
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.