Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00228267
Eligibility Criteria:
Inclusion criteria
* Adult subjects (18-65 years) with CDH by the criteria of Silberstein and Lipton.41 i.e. on the basis of pre-randomization history suffer chronic headaches lasting more than 4 hours a day for more than 15 days a month.
* Previously investigated to exclude serious treatable pathology.
* On the basis of the pre-randomization headache diary: the average pain intensity during each episode should be at least 5 /10 on the Numerical Rating Scale (NRS) on 4 days out of 7.
* Quality of life and function should be impaired as evidenced by a (pre-randomization) Headache Disability Index (HDI) of at least 40.
Exclusion criteria
History of the following:
* Known or suspected allergy to propofol, intralipid or midazolam,
* In emergency or life-threatening situations,
* Those having language barriers (e.g. illiterate, not English-speaking, dysphasic),
* Known or suspected difficult airway or sleep apnea,
* Severe respiratory disease,
* Neuromuscular disease,
* Seizure disorder,
* Severe cardiac disease,
* Severe gastroesophageal reflux disease,
* Pancreatitis,
* Lipid disorders,
* Receiving Total Parenteral Nutrition,
* Body mass index \> 35, diabetes or major endocrine disorder,
* Hepatic or renal failure,
* Unstable psychiatric disorder,
* Known drug abuse,
* Pregnancy,
* Cognitively impaired.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00228267
Study Brief:
Protocol Section:
NCT00228267