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A Novel Approach to Infantile Spasms
Plain-language guide to NCT03347526: phase 3 randomized trial of Cosyntropin, 394 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03347526
- Phase
- phase 3
- Status
- suspended
- Start
- 2018-04-19
- Completion (planned or actual)
- 2021-06
- Participants
- 394 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Infantile Spasm
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Cosyntropin.
It had three arms (groups): one (experimental), one (experimental) and Vigabatrin (active comparator).
The registry classes the interventions as drug.
More on the Plan
This is a prospective randomized trial comparing 3 treatment arms: 1.
Who Took Part
Enrollment: 394 planned participants were the target.
It was open to people of any sex aged from 2 months up to 2 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: New onset infantile spasms. Age \> 2 months. Age\< 2 years. Hypsarrhythmia on video-EEG. Normal renal function.
The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: prior treatment given for infantile spasms; absence of hypsarrhythmia; inability for the parent or caregiver to provide consent.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Cosyntropin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Cosyntropin study did not mask who received what.
It started in 2018-04-19 with completion listed for 2021-06.
It ran at 14 sites in United States (14).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b) (time frame: 2 weeks).
It also tracked 4 secondary outcomes, for example Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) and Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Cosyntropin in 394 people.
Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cosyntropin compound page, all human trials.
Our Notes on the Compound
Cosyntropin: A synthetic 24-amino-acid fragment of ACTH (also tetracosactide, Synacthen) used mainly in the adrenal stimulation test.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.