Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms (PREDVGB)
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|ClinicalTrials.gov Identifier: NCT02299115|
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : April 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infantile Spasms||Drug: Prednisolone Drug: Vigabatrin||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms|
|Actual Study Start Date :||September 5, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||March 2021|
Single center, prospective, observational, open trial using high-dose oral prednisolone as first-line treatment for newly diagnosed Infantile Spasms (non-Tuberous Sclerosis)
Other Name: pms-prednisolone
Active Comparator: Vigabatrin
Retrospective controls composed of our cohort of non-Tuberous Sclerosis Infantile Spasms patients from January 2010- September 2013 who received Vigabatrin as first-line treatment.
Other Name: Sabril
- Resolution of Infantile spasms and Hypsarrhythmia [ Time Frame: 14 days ]
Clinical response: cessation of spasms: no reported spasms for at least 48 hours including day 14 of the trial.
EEG response: complete resolution of hypsarrhythmia or modified hypsarrhythmia pattern, on follow up EEG at approximately 2 weeks of the trial.
- Clinical or EEG relapse of Infantile Spasms [ Time Frame: 6 months ]
Clinical relapse: any spasm occurring after 2 weeks up to and including final clinical assessment at approximately 5 months (+/- 2weeks) post-treatment in an infant who had cessation of spasms.
EEG Relapse: recurrence of hypsarrhythmia/modified hypsarrhythmia pattern after one previous EEG showing resolution of hypsarrhythmia
- Seizure outcome at final follow up (presence or absence of any seizure types at final follow up as assessed by seizure diary and on history at final follow up visit) [ Time Frame: 6 months ]Clinical assessment of the presence or absence of any seizure types at final follow up as assessed by seizure diary and on history at final follow up visit.
- Time to cessation of Infantile spasms [ Time Frame: 14 days ]Length of time in days to achieve cessation of Infantile spasms
- Time to relapse [ Time Frame: 6 months ]Length of time (in days) from the initial resolution of Infantile spasms to the relapse of Infantile spasms
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): NCT02299115
|Contact: Cristina Go, MDfirstname.lastname@example.org|
|Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Cristina Go, MD 416-813-7353 email@example.com|
|Principal Investigator: Carter Snead, MD|
|Sub-Investigator: Kevin C Jones, MD|
|Sub-Investigator: Blathnaid McCoy, MD|
|Sub-Investigator: Ayako Ochi, MD|
|Sub-Investigator: Jennifer Boyd, RN,MSCN|
|Principal Investigator:||Carter Snead, MD||The Hospital for Sick Children|