EUCTR2014-004464-38-NL
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention - STRIVE study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amgen Inc
- Enrollment
- 852
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Criteria to be assessed prior to entering the subject into the initial screening phase and/or baseline phase:
- •Adults \= 18 to \= 65 years of age upon entry into screening
- •History of migraine (with or without aura) for \= 12 months prior to screening according to the IHS Classification ICHD\-3 based on medical records and/or patient self\-report
- •Migraine frequency: \= 4 and \< 15 migraine days per month on average across the 3 months prior to screening
- •Headache (ie, migraine and non\-migraine headache) frequency: \< 15 headache days per month on average across the 3 months prior to screening
- •Criteria to be assessed during the baseline phase and confirmed prior to randomizing the subject into the double\-blind treatment phase:
- •Migraine frequency: \= 4 and \< 15 migraine days during the baseline phase based on the eDiary calculations
- •Headache frequency: \< 15 headache days during the baseline phase based on the eDiary calculations
- •Demonstrated at least 80% compliance with the eDiary
- •Are the trial subjects under 18? no
Exclusion Criteria
- •Older than 50 years of age at migraine onset
- •History of cluster headache or hemiplegic migraine headache
- •Unable to differentiate migraine from other headaches
- •No therapeutic response with \> 2 of the following 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
- •\- Category 1: Divalproex sodium, sodium valproate
- •\- Category 2: Topiramate
- •\- Category 3: Beta blockers
- •\- Category 4: Tricyclic antidepressants
- •\- Category 5: Serotonin\-norepinephrine reuptake inhibitors
- •\- Category 6: Flunarizine, verapamil
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
A study to determine if ALXN2220 is effective, safe, and tolerable in adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM).Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]CTIS2023-506669-70-00Alexion Pharmaceuticals Inc.982
Active, not recruiting
Phase 1
Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCCResectable high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC)MedDRA version: 20.0 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-001974-76-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.570
Active, not recruiting
Phase 1
Phase 3 Study of Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)Recurrent, Platinum-Sensitive Ovarian CancerMedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-005099-21-NOMersana Therapeutics, Inc.581
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to study the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents = 6 to <18 years of ageAcute Migraine (with or without aura)MedDRA version: 20.0Level: PTClassification code 10052787Term: Migraine without auraSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2021-005246-15-PLPfizer Inc.640
Active, not recruiting
Phase 1
Combining chemotherapy with either the medication entospletinib or a placebo for adults with acute myeloid leukemia that has a nucleophosmin-1 abnormalityAcute Myeloid LeukemiaMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2021-000761-33-PLKronos Bio, Inc.180