EUCTR2018-003342-16-AT
Active, not recruiting
Phase 1
A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
ConditionsChronic migraineMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsAimovig
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic migraine
- Sponsor
- Amgen Inc
- Enrollment
- 687
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •101 Subject has provided informed consent prior to initiation of any study\-specific activities/procedures
- •102 Age \= 18 years on entry into the study
- •103 Documented history of migraine without aura and/or migraine with aura according to the ICHD\-3 Classification for \= 12 months at screening
- •104 Documented history of CM for a minimal duration of 6 months before screening
- •105 Current diagnosis of MOH
- •106 History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability
- •107\. \= 14 headache days during the 28\-day baseline period out of which \= 8 headache days meet criteria as migraine days
- •108 Observation of acute migraine medication overuse during baseline. Medication overuse at baseline is defined as:
- •\- \= 10 days of combination treatment OR
- •\- \= 10 days of short\-acting opioids/opioid\-containing medication OR
Exclusion Criteria
- •201 Age \> 50 years at migraine onset or \> 65 years at CM onset
- •202 History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
- •203 Current concomitant diagnosis of a secondary type of headache other than MOH
- •204 History of clinically significant orofacial pain (eg, painful cranial neuropathies, temporomandibular disorder) that in the opinion of the investigator or Amgen's physician, if consulted, could interfere with the study evaluation, procedures or completion
- •205 Chronic headache with continuous pain, in which the subject does not experience headache\-free periods of any duration
- •206 No therapeutic response in prevention of migraine after an adequate therapeutic trial of \> 3 of the following medication categories. These medication categories include:
- •\- Category 1: Topiramate
- •\- Category 2: Other antiepileptics (eg, divalproex sodium, sodium
- •valproate, carbamazepine)
- •\- Category 3: Beta blockers
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Phase 4 Randomized Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse HeadacheEUCTR2018-003342-16-ESAmgen Inc687
Active, not recruiting
Phase 1
A Phase 4 Randomized Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse HeadacheChronic migraineMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2018-003342-16-PTAmgen Inc620
Active, not recruiting
Phase 1
A study to assess the clinical benefit of Midodrine Hydrochloride in patients with symptomatic orthostatic hypotension.EUCTR2012-005761-12-SKShire Development LLC18
Active, not recruiting
Phase 1
A Phase 4 Randomized Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse HeadacheChronic migraineMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2018-003342-16-CZAmgen Inc687
Active, not recruiting
Phase 1
A Phase 4 Randomized Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse HeadacheEUCTR2018-003342-16-PLAmgen Inc620