A Phase 3 interventional study of Cosyntropin Injectable Suspension, 1 mg/mL and Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin in Infantile Spasm, sponsored by University of Colorado, Denver. Suspended at 14 sites in United States. Open to participants aged 2 Months to 2 Years. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by University of Colorado, Denver · Phase 3, Interventional, and Treatment
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).
This is a prospective randomized trial comparing 3 treatment arms:
The data is expected to demonstrate greater efficacy with Cosyntropin Injectable Suspension, 1 mg/mL than vigabatrin for the treatment of IS.
47 studies on the registry are indexed under Spasms, Infantile; 8 are open to participants now.
This study's planned enrollment of 394 is above the median of 40 across 33 interventional studies indexed under Spasms, Infantile.
Browse Spasms, Infantile studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
Diagnosis of:
Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
Drug: Cosyntropin Injectable Suspension, 1 mg/mL
Drug: Vigabatrin
Injectable
Drug page: Cosyntropin
Injectable + oral solution
oral
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
Time frame: 2 weeks
A comparison of combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become spasm-free as defined by a) and b)
a) Resolution of clinical spasms for 48 hours at 2 weeks sustained until day 42, and b) Resolution of hypsarrhythmia via video EEG at 2 weeks.
Time frame: Day 14-42
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.
Time frame: 6 months
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Adaptive Behavior Assessment System (ABAS III) at 18 months chronological age.
Time frame: 18 months chronological age
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Vineland II at 18 months chronological age.
Time frame: 18 months chronological age
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2018 (actual). Primary completion is estimated for Jun 2021, 38 months after the start.
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This study is suspended, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cosyntropin
University of Colorado, Denver →