2024-517079-19-00招募中4 期
MR-Spectroscopy: Investigating neurochemical changes in brain metabolism in migraineurs before and after CGRP-Antibody treatment – a randomized, controlled, open-label trial.
Medizinische Universitaet Innsbruck1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年10月30日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Difference in neurotransmitter level in the occipital cortex before and after 12 weeks of CGRP antibody treatment in the interventional group compared to the control group assessed by MR spectroscopy at baseline and FU visit 3.
研究概览
简要总结
To investigate whether CGRP-antibody treatment (Fremanezumab 225mg monthly) leads to neurochemical changes in the occipital cortex and the thalamus of patients with migraine with and without aura.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before assessment is performed
- •Adults > 18 and < 65 of age upon entry into screening
- •Documented history of migraine with or without aura > 12 months prior to screening according to the International Classification of Headache Disorders - 3rd Edition (ICHD-3)
- •Migraine frequency ≥ 4 and ≤ 15 migraine days per month across the 3 months prior to screening based on retrospective reporting
- •Subject has not received a CGRP mAB for migraine prophylaxis in the past
- •Subject can differentiate migraine from other headaches
- •Lack of contraindication for MRI
排除标准
- •Older than 50 years of age at migraine onset
- •History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes
- •Previous exposure to Fremanezumab 225mg monthly or 675mg quarterly or exposure to any other prophylactic CGRP-targeted therapy (prior to and during the study)
- •History of cluster headache or hemiplegic migraine headache
- •Unable to differentiate migraine from other headaches
- •Exposure to botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline period, during the baseline period, or treatment period
- •Traditional medications and/or procedures are not allowed if not used at a stable dose/frequency for at least 3 months prior to randomization and during the study
- •Active chronic pain syndromes (e.g., fibromyalgia, chronic pelvic pain)
- •History of major psychiatric disorders (such as schizophrenia or bipolar disorder) or current evidence of depression
- •History of seizure disorder or other significant neurological conditions other than migraine
- •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
- •Human immunodeficiency virus (HIV) infection by history
- •Unlikely to be able to complete all protocol required study procedures to the best of the subject’s and investigator’s knowledge
- •Taken the following for any indication during 2 months prior to screening: -Ergotamines or triptans on ≥10 days per month, or -NSAIDs, acetaminophen on ≥15 days per month, or -Opioid-containing analgesics on ≥4 days per month
- •History or evidence of any other unstable or clinically significant medical condition
- •Subject has any clinically significant vital sign during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
- •Coronary artery disease, myocardial infarction, stroke, transient ischemic attack, stable or unstable angina pectoris, carotid or vertebro-basilar artery disease, other cerebrovascular conditions (e.g.: AV malformation, aneurysm)
- •Evidence of drug or alcohol abuse or dependence in the past, based on medical records, patient self-report
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing with study treatment
- •Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
结局指标
主要结局
Difference in neurotransmitter level in the occipital cortex before and after 12 weeks of CGRP antibody treatment in the interventional group compared to the control group assessed by MR spectroscopy at baseline and FU visit 3.
Difference in neurotransmitter level in the occipital cortex before and after 12 weeks of CGRP antibody treatment in the interventional group compared to the control group assessed by MR spectroscopy at baseline and FU visit 3.
次要结局
- Comparison of neurochemical/metabolic changes between study participants with migraine with and without aura.
- Change in migraine frequency and intensity over the treatment period assessed by MIDAS and HIT 6 questionnaire
- Correlation between the neurochemical changes and the clinical symptoms (e.g. migraine frequency, intensity or duration)
研究者
University Hospital for Neurology
Scientific
Medizinische Universitaet Innsbruck
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
MR-Spectroscopy Study: Investigating changes in brain metabolism in migraine patients before and after therapeutic influenceEpisodic migraineEUCTR2021-006219-28-ATMedical University Innsbruck38
招募中
不适用
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease ActivityNCT07292480Centre Hospitalier Universitaire de Nīmes84
招募中
2 期
Is [18F]-DPA-714 PET a good marker of neuroinflammation in autoimmune encephalitis? (EAI-714)autoimmune encephalitis2025-522768-33-00Centre Hospitalier Universitaire De Toulouse20
招募中
1 期
Remimazolam NeuroImagingNCT07290205Keith M Vogt60
招募中
1 期
Study of RMC-6291 and RMC-6236 With Other Anti-Cancer Agents in Patients With RAS G12C-Mutated NSCLC - Subprotocol ALung Cancer2023-509571-16-00Revolution Medicines Inc.158