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Nuedexta for the Treatment of Adults With Autism (Nuedexta)

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ClinicalTrials.gov Identifier: NCT01630811
Recruitment Status : Completed
First Posted : June 28, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Chez, MD, Sutter Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Autism
Interventions Drug: Nuedexta
Other: Placebo
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nuedexta First Placebo Second Placebo First Nuedexta Second
Hide Arm/Group Description Participants first received Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. After a washout period of 4 weeks, they then received Placebo tablet (matching Neudexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. Participants first received Placebo tablet (matching Neudexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. After a washout period of 4 weeks, they then received Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
Period Title: First Intervention (8 Weeks)
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: Washout (4 Weeks)
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: Second Intervention (8 Weeks)
Started 7 6
Completed 6 6
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Second Washout (4 Weeks)
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Participants who were randomized to receive either Nuedexta tablet (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) or Placebo tablet (matching Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg)
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
21.68  (3.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
2
  15.4%
Male
11
  84.6%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants
28.00  (5.86)
Autism Diagnostic Observation Schedule (ADOS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants
16.31  (12.04)
[1]
Measure Description: The Autism Diagnostic Observation Schedule (ADOS) is a semi-structured assessment of communication, social interaction, and play (or imaginative use of materials) for individuals suspected of having autism or other pervasive developmental disorders. The total score ranges from 0 to 28 with 0 representing no abnormality present. A child is suspected to have Autism if the total ADOS score is greater than 7. The mean of the total ADOS scores is listed below.
1.Primary Outcome
Title Change in Maladaptive Behaviors
Hide Description Demonstrate a change in frequency and intensity of maladaptive behaviors as measured by the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8 weeks over subjects given placebo. This checklist consists of 20 questions relating to behavior and the reported total score is on a scale from 0 to 60. A lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. The below values are the difference in ABC scores from baseline to 8 weeks. A negative difference indicates improved behavior.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew at the time of crossover.
Arm/Group Title Nuedexta Placebo
Hide Arm/Group Description:
Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
Oral, one time daily for 7 days.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.62  (11.12) -1.08  (8.46)
2.Primary Outcome
Title Primary Safety Endpoints
Hide Description Number of serious adverse events
Time Frame Week 0 through week 25
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta Placebo
Hide Arm/Group Description:
Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
Placebo tablet equivalent to Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Change in Aggressive Behavior
Hide Description Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS). It consists of a scale from 0 - 40, and a lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. Reported is the mean difference in scores from baseline to 8 weeks. A positive score indicates more aggressive behavior and a negative score indicates less aggressive behavior.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject withdrew at the time of crossover.
Arm/Group Title Nuedexta Placebo
Hide Arm/Group Description:
Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.92  (2.78) 0.08  (1.88)
Time Frame Eight weeks for each intervention with 4 weeks washout in between interventions and at the end (total 24 weeks).
Adverse Event Reporting Description Safety population included all participants who received at least one dose of intervention.
 
Arm/Group Title Nuedexta Placebo
Hide Arm/Group Description Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. Placebo tablet equivalent to Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
All-Cause Mortality
Nuedexta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nuedexta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nuedexta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Michael Chez, MD
Organization: Sutter Medical Group, Neurology
Phone: (916) 454-6667
Responsible Party: Michael Chez, MD, Sutter Health
ClinicalTrials.gov Identifier: NCT01630811     History of Changes
Other Study ID Numbers: CHKI-Nued0911
First Submitted: June 26, 2012
First Posted: June 28, 2012
Results First Submitted: November 4, 2016
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017