SANCC: Clinical Trial Early Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03950037|
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Neurocysticercosis||Drug: Albendazole||Phase 2|
I. To estimate the risk of serious adverse events (SAE) related to intervention in asymptomatic SANCC; these include drug-related side effects, moderate/severe intracranial hypertension, hydrocephalus requiring shunting or endoscopy, stroke, status epilepticus, or unexplained death.
Participants will be hospitalized for approximately 15-30 days while they receive treatment with the antiparasitic drug albendazole, as well as additional drugs (dexmathesaone and omeprazole) to address potential treatment complications. Participants will have continuous monitoring for adverse events while in the hospital. After participants are released to home, they will monitored for adverse events for an additional 12 months through home visits, telephone contact, and monthly clinical evaluations with serologic and radiologic assessment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: Medical intervention
Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole.
Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.
- Safety; severe adverse events [ Time Frame: The 3 month period directly following the intervention ]Proportion of subjects that experience any severe adverse event that is directly related to the treatment intervention
- Safety; all adverse events [ Time Frame: The 12 month period directly following the intervention ]Frequency and type of all adverse events
- Diagnostic; antigen levels [ Time Frame: Months 3,6,9, and 12 after intervention ]Correlation between urine and serum levels of circulating parasite antigen and lesion resolution on MRI as a potential marker of treatment effect
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950037
|Contact: Seth E O'Neal, MD MPH||(504)firstname.lastname@example.org|
|Contact: Hector H Garcia, MD PhD||511 email@example.com|
|Principal Investigator:||Seth E O'Neal, MD MPH||Oregon Health and Science University|
|Principal Investigator:||Hector H Garcia, MD PhD||Universidad Peruana Cayetano Heredia|