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Trial record 8 of 11 for:    Aevi

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
Sponsor:
Information provided by (Responsible Party):
Aevi Genomic Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Drug: NFC-1
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NFC-1 Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
Placebo Matching placebo capsules

Participant Flow:   Overall Study
    NFC-1   Placebo
STARTED [1]   49   52 
Safety Population [2]   47   50 
Modified Intent to Treat Population [3]   46   50 
COMPLETED   37   39 
NOT COMPLETED   12   13 
[1] All randomized subjects (Intent to Treat Population)
[2] All randomized subjects who took at least 1 dose of study drug
[3] Subjects who took at least 1 dose of study drug and have valid baseline and post baseline assessment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
NFC-1 Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
Placebo Matching placebo capsules
Total Total of all reporting groups

Baseline Measures
   NFC-1   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   50   97 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.8  (1.40)   14.4  (1.68)   14.1  (1.58) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  44.7%      15  30.0%      36  37.1% 
Male      26  55.3%      35  70.0%      61  62.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   2.1%      1   2.0%      2   2.1% 
Asian      0   0.0%      1   2.0%      1   1.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      11  23.4%      18  36.0%      29  29.9% 
White      29  61.7%      26  52.0%      55  56.7% 
More than one race      6  12.8%      3   6.0%      9   9.3% 
Unknown or Not Reported      0   0.0%      1   2.0%      1   1.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   47   50   97 


  Outcome Measures

1.  Primary:   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) ]

2.  Primary:   Clinical Global Impression – Global Improvement (CGI –I) Response   [ Time Frame: Visit 3 to Visit 8 (Week 6) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Garry A Neil, MD
Organization: Aevi Genomic Medicine
phone: 610-254-4208
e-mail: garry.neil@aevigenomics.com



Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT02777931     History of Changes
Other Study ID Numbers: MDGN-NFC1-ADHD-201
First Submitted: May 13, 2016
First Posted: May 19, 2016
Results First Submitted: January 25, 2018
Results First Posted: March 29, 2018
Last Update Posted: April 25, 2018