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NCT01723787 · ClinicalTrials.gov registry record
Genetic Studies in Patients and Families With Infantile Spasms
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 63
- Enrollment target
NCT01723787: Completed study, sponsored by University of Colorado, Denver.
NCT01723787 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01723787 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
Study Summary
Infantile spasms (IIS), a characteristic epilepsy syndrome of infancy with often catastrophic developmental consequences, is known in some patients to have many different genetic, metabolic and structural etiologies. However, for most patients IIS is the only presenting clinical feature and the specific cause is unknown. Only two FDA approved pharmacologic treatments for IIS exist, Adrenocorticotropic hormone (ACTH) and vigabatrin. While vigabatrin may be the treatment of choice for Tuberous Sclerosis as a cause for IS, ACTH is the treatment of choice for all others. Unfortunately, a substantial number of patients may still not respond to ACTH and there is no a priori way that suggests which patients may be responders. This has led to the following key questions: Can novel genetic analyses determine known genetic causes of IS with greater efficiency (more timely and cost-effective)? Can novel genetic analyses determine previously unknown disease modifying genes that predispose individuals to develop IS? Can novel genetic analyses elaborate genes and gene polymorphisms that favor ACTH responsiveness? Do these polymorphisms suggest strategies to improve ACTH responsiveness?
Primary Outcome
Apply novel genetic analyses to determine possible causes of cryptogenic IIS and evaluate adding novel genetic analyses to standard practice for determining causes of IIS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-11-30 |
What the finished NCT01723787 record still lists
NCT01723787 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01723787 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01723787 about?
NCT01723787 is a clinical study titled "Genetic Studies in Patients and Families With Infantile Spasms". Infantile spasms (IIS), a characteristic epilepsy syndrome of infancy with often catastrophic developmental consequences, is known in some patients to have many different genetic, metabolic and structural etiologies. However, for most patients IIS is the only presenting clinical feature and the spec...
What is the current status of trial NCT01723787?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2013-03. Estimated completion is 2018-11-30.
Who is sponsoring clinical trial NCT01723787?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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