Efficacy and Safety of NFC-1 in Adolescents With Genetic Disorders Impacting mGluR and ADHD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02777931|
Recruitment Status : Completed
First Posted : May 19, 2016
Results First Posted : March 29, 2018
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Drug: NFC-1 Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||February 10, 2017|
|Actual Study Completion Date :||February 17, 2017|
Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules for oral administration.
NFC-1 is supplied as size 2 hard gelatin capsules.
Other Name: NFC1
Placebo Comparator: Placebo
Matching placebo capsules.
Matching placebo capsules
Other Name: Control
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score [ Time Frame: Baseline to Visit 8 (Week 6) ]
The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often".
The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.
- Clinical Global Impression - Global Improvement (CGI -I) Response [ Time Frame: Visit 3 to Visit 8 (Week 6) ]
The CGI-I item is rated on a 7-point scale from 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", 7 = "Very much worse".
Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response
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): NCT02777931
|United States, Maryland|
|The Clinical Trials Center at Kennedy Krieger Institute|
|Baltimore, Maryland, United States, 21205|