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:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT00226668
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of a primary malignant glioma.
* Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
* If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
* Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
* Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.
Exclusion Criteria:
* Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
* Systemic steroid use for any other indication than peritumoral brain edema.
* Patients on dexamethasone or anticonvulsant therapy.
* Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
* Central nervous system (CNS) infection.
* Conditions that are considered contradictions for patients to receive niacin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00226668
Study Brief:
Protocol Section:
NCT00226668