Italian Trigeminal Autonomic Cephalalgias Assessment Study (ITACA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Number of participants with premonitory symptoms
研究概览
简要总结
ITACA is a prospective, multicenter, observational longitudinal cohort study conducted in routine clinical practice at six Italian headache centers. Approximately 800 adults with trigeminal autonomic cephalalgias (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) diagnosed according to ICHD-3 will be enrolled. The study will describe clinical features and real-world treatment patterns and will evaluate treatment effectiveness and tolerability, changes in clinical features over time, comorbidities, lifestyle factors, patient-reported outcomes, and predictors of treatment response and disease progression. No investigational intervention will be assigned; treatments are prescribed by treating physicians as part of routine clinical care. Participants will be assessed at baseline and during routine follow-up visits, approximately every 3-6 months or as clinically indicated, for up to 3 years. Relevant clinical data already available in medical records before enrollment may also be collected to improve baseline characterization and reconstruction of disease course.
详细描述
Trigeminal autonomic cephalalgias are rare and highly disabling primary headache disorders characterized by unilateral pain and ipsilateral cranial autonomic symptoms. Their clinical heterogeneity, frequent misdiagnosis, diagnostic delay, and the limited availability of large longitudinal datasets make accurate phenotypic characterization and evidence-based treatment selection difficult. ITACA is designed to address these gaps through systematic real-world data collection in a multicenter setting.
The study is a prospective, multicenter, observational longitudinal cohort conducted in routine outpatient clinical practice. Recruitment is planned for 3 years, with follow-up for up to 3 years per participant and an overall study duration of approximately 6 years. Consecutive eligible adult outpatients with a diagnosis of cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua according to ICHD-3 will be invited to participate. Relevant pre-enrollment clinical information already available in medical records may be collected retrospectively at baseline to improve characterization of disease history.
No protocol-mandated treatment or investigational intervention is assigned. Acute and preventive treatments are prescribed independently by treating physicians according to routine clinical practice. Data are collected at baseline and at routine follow-up visits, expected approximately every 3-6 months or whenever clinically indicated. Collected information includes attack frequency, duration and severity, cranial autonomic and other accompanying symptoms, temporal patterns, disease course, treatment history and ongoing treatment exposure, treatment effectiveness and tolerability, adverse events, comorbidities, lifestyle factors, concomitant medications, headache diary information, and patient-reported measures. Questionnaires may include PGIC, ASC-12, EQ-5D, SF-36, CHIQ, HARS, HDRS, HADS, LDQ, and PSQI according to routine practice and local availability. Data are recorded in a standardized electronic case report form using REDCap.
The planned sample size is approximately 800 participants, expected to include about 70-80% with cluster headache and 20-30% with other trigeminal autonomic cephalalgias. Analyses will be primarily descriptive and will include longitudinal and multivariable models to assess clinical characteristics, treatment outcomes, and predictors of response, refractoriness, and disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Diagnosis of trigeminal autonomic cephalalgia (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) according to ICHD-3 criteria.
- •Ability to provide written informed consent.
- •Availability for longitudinal follow-up and data collection.
排除标准
- •Secondary headache disorders.
- •Uncertain or unconfirmed diagnosis of a trigeminal autonomic cephalalgia.
- •Severe cognitive impairment or psychiatric condition interfering with reliable data collection.
- •Any condition that, in the investigator's judgment, may compromise participation or follow-up.
结局指标
主要结局
Number of participants with premonitory symptoms
时间窗: 3 years
Number and percentage of participants reporting one or more premonitory symptoms associated with their trigeminal autonomic cephalalgia.
Number of participants with postdromal symptoms
时间窗: 3 years
Number and percentage of participants reporting one or more postdromal symptoms associated with their trigeminal autonomic cephalalgia.
Number of participants with a circadian attack pattern
时间窗: 3 years
Number and percentage of participants reporting a recurrent within-day temporal pattern in the occurrence of headache attacks.
Number of participants with a circannual attack pattern
时间窗: 3 years
Number and percentage of participants reporting a recurrent seasonal or annual temporal pattern in the occurrence of headache attacks.
Number of participants by disease-course category
时间窗: 3 years
Number and percentage of participants classified according to the applicable trigeminal autonomic cephalalgia disease-course category, including episodic and chronic forms where applicable.
Number of participants with a transition in disease-course category
时间窗: 3 years
Number and percentage of participants who transition between applicable disease-course categories, including transitions between episodic and chronic forms where applicable.
Number of participants receiving each acute treatment
时间窗: 3 years
Number and percentage of participants receiving each type of acute treatment for trigeminal autonomic cephalalgia in routine clinical practice.
Number of participants receiving each preventive treatment
时间窗: 3 years
Number and percentage of participants receiving each type of preventive treatment for trigeminal autonomic cephalalgia in routine clinical practice.
Number of participants initiating a new preventive treatment
时间窗: 3 years
Number and percentage of participants who initiate a new preventive treatment during follow-up.
Number of participants switching preventive treatment
时间窗: 3 years
Number and percentage of participants who switch from one preventive treatment to another during follow-up.
Number of participants discontinuing preventive treatment
时间窗: 3 years
Number and percentage of participants who discontinue a preventive treatment during follow-up. Reasons for discontinuation will be categorized where available.
Duration of preventive treatment retention
时间窗: 3 years
Time from initiation of a preventive treatment to permanent discontinuation of that treatment, expressed in months.
Baseline and routine follow-up visits through 3 years after enrollment
时间窗: 3 years
Number of headache attacks occurring during a 7-day period, assessed from headache diary data when available or from clinical history collected at study visits. Values will be recorded according to the participant's trigeminal autonomic cephalalgia subtype.
Duration of individual headache attacks
时间窗: 3 years
Typical duration of headache attacks, expressed in minutes, assessed from headache diary data when available or from clinical history collected at study visits.
Headache attack pain intensity assessed using the 11-point Numerical Rating Scale
时间窗: 3 years
Pain intensity will be rated on an 11-point Numerical Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Number of participants with cranial autonomic symptoms
时间窗: 3 years
Number and percentage of participants reporting cranial autonomic symptoms associated with headache attacks. Symptom categories collected include lacrimation, conjunctival injection, nasal congestion, ptosis, and miosis.
次要结局
- Change from baseline in HARS score(3 years)
- Change from baseline in weekly attack frequency during preventive treatment(3 years)
- Number of participants achieving at least a 50% reduction in weekly attack frequency(3 years)
- Change from baseline in days per week requiring acute headache medication(3 years)
- Number of participants achieving sustained attack remission(3 years)
- Number of participants experiencing adverse events during preventive treatment(3 years)
- Number of participants experiencing serious adverse events during preventive treatment(3 years)
- Number of participants discontinuing preventive treatment because of adverse events(3 years)
- Number of participants achieving pain freedom 15 minutes after acute treatment of the first treated attack(3 years)
- Proportion of consecutively treated attacks with pain freedom 15 minutes after acute treatment(3 years)
- Number of participants achieving pain relief 15 minutes after acute treatment(3 years)
- Number of participants achieving pain relief 2 hours after acute treatment(3 years)
- Functional Disability Scale score 15 minutes after acute treatment(3 years)
- Functional Disability Scale score 2 hours after acute treatment(3 years)
- Number of participants with headache recurrence within 12 hours after initial pain freedom(3 years)
- Number of participants experiencing adverse events following acute treatment(3 years)
- Number of participants experiencing serious adverse events following acute treatment(3 years)
- Number of participants discontinuing an acute treatment because of adverse events(3 years)
- PGIC score(3 years)
- Change from baseline in ASC-12 score(3 years)
- Change from baseline in HDRS score(3 years)
- Change from baseline in HADS score(3 years)
- Change from baseline in modified LDQ score(3 years)
- Change from baseline in PSQI score(3 years)
- Change from baseline in EQ-5D measure(3 years)
- Change from baseline in SF-36 score(3 years)
- Change from baseline in CHIQ score(3 years)