An Open-Label Study of DCCR Tablet in Patients With PWS
NCT ID: NCT04086810
Last Updated: 2021-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-10-31
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCCR
25 - 450 mg DCCR
DCCR
Once daily oral administration
Interventions
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DCCR
Once daily oral administration
Eligibility Criteria
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Inclusion Criteria
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
* Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.
Exclusion Criteria
* Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
* Any new disease, condition, or circumstance, which may significantly impact subject safety
4 Years
ALL
No
Sponsors
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Soleno Therapeutics, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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C603
Identifier Type: -
Identifier Source: org_study_id
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