Trials / Terminated
TerminatedNCT00442104
Open-label Extension to Protocol 1042-0500
An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolone in Treatment of Patients Diagnosed With Infantile Spasms.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Marinus Pharmaceuticals · Industry
- Sex
- All
- Age
- 4 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
To allow open-label extension to patients who have completed Protocol 1042-0500
Detailed description
Patient should have completed all scheduled clinical study visits in the double blind, controlled trial (Protocol 1042-0500) and have been deemed eligible (had a response to treatment) by the Investigator. Male or female, with a diagnosis of IS with a video EEG (vEEG) recording confirming the diagnosis. There will be a total of 14 visits over 99(+or-1)week. A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ganaxolone |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2007-03-01
- Last updated
- 2024-05-28
- Results posted
- 2023-06-02
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00442104. Inclusion in this directory is not an endorsement.