Efficacy and Safety of NFC-1 in Adolescents With Genetic Disorders Impacting mGluR and ADHD
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ClinicalTrials.gov Identifier: NCT02777931 |
Recruitment Status :
Completed
First Posted : May 19, 2016
Results First Posted : March 29, 2018
Last Update Posted : April 25, 2018
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Sponsor:
Aevi Genomic Medicine, LLC, a Cerecor company
Information provided by (Responsible Party):
Aevi Genomic Medicine, LLC, a Cerecor company
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Tracking Information | |||
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First Submitted Date ICMJE | May 13, 2016 | ||
First Posted Date ICMJE | May 19, 2016 | ||
Results First Submitted Date ICMJE | January 25, 2018 | ||
Results First Posted Date ICMJE | March 29, 2018 | ||
Last Update Posted Date | April 25, 2018 | ||
Study Start Date ICMJE | June 2016 | ||
Actual Primary Completion Date | February 10, 2017 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Change from baseline in ADHD-rating scale (ADHD-RS-5) Total Score [ Time Frame: Baseline to Visit 8 (Week 6) ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE |
Change from baseline in Clinical Global Impression - Global Improvement (CGI -I) Scale. [ Time Frame: Baseline to Visit 8 (Week 6) ] | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Efficacy and Safety of NFC-1 in Adolescents With Genetic Disorders Impacting mGluR and ADHD | ||
Official Title ICMJE | A Multicenter, 6-week, Double-blind, Randomized, Placebo-controlled, Parallel-design Study to Assess the Efficacy and Safety of NFC-1 in Adolescents (Ages 12-17) With Genetic Disorders Impacting Metabotropic Glutamate Receptors and ADHD | ||
Brief Summary | This is a randomized, double-blind, placebo-controlled, parallel-group study of NFC-1 versus placebo in adolescents with ADHD who have genetic disorders impacting mGluRs. | ||
Detailed Description | This is a randomized, double-blind, placebo-controlled, parallel-group study of adolescents with ADHD who have genetic disorders impacting mGluRs. Approximately 90 subjects will receive randomized treatment with NFC-1 or placebo. Dosing will be optimized during the first 4 weeks of treatment, based on clinical response and tolerability, and maintained for an additional 2 weeks. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Attention Deficit Disorder With Hyperactivity | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
101 | ||
Original Estimated Enrollment ICMJE |
90 | ||
Actual Study Completion Date ICMJE | February 17, 2017 | ||
Actual Primary Completion Date | February 10, 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 17 Years (Child) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02777931 | ||
Other Study ID Numbers ICMJE | MDGN-NFC1-ADHD-201 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Responsible Party | Aevi Genomic Medicine, LLC, a Cerecor company | ||
Study Sponsor ICMJE | Aevi Genomic Medicine, LLC, a Cerecor company | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Aevi Genomic Medicine, LLC, a Cerecor company | ||
Verification Date | March 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |