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Trial Outcomes & Findings for Nuedexta for the Treatment of Adults With Autism (NCT NCT01630811)

NCT ID: NCT01630811

Last Updated: 2017-12-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2017-12-08

Participant Flow

Participant milestones

Participant milestones
Measure
Nuedexta First Placebo Second
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.
Placebo First Nuedexta Second
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.
First Intervention (8 Weeks)
STARTED
7
6
First Intervention (8 Weeks)
COMPLETED
7
6
First Intervention (8 Weeks)
NOT COMPLETED
0
0
Washout (4 Weeks)
STARTED
7
6
Washout (4 Weeks)
COMPLETED
7
6
Washout (4 Weeks)
NOT COMPLETED
0
0
Second Intervention (8 Weeks)
STARTED
7
6
Second Intervention (8 Weeks)
COMPLETED
6
6
Second Intervention (8 Weeks)
NOT COMPLETED
1
0
Second Washout (4 Weeks)
STARTED
6
6
Second Washout (4 Weeks)
COMPLETED
6
6
Second Washout (4 Weeks)
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Nuedexta First Placebo Second
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.
Placebo First Nuedexta Second
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.
Second Intervention (8 Weeks)
Withdrawal by Subject
1
0

Baseline Characteristics

Nuedexta for the Treatment of Adults With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=13 Participants
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)
Age, Continuous
21.68 years
STANDARD_DEVIATION 3.30 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
Body Mass Index (BMI)
28.00 kg/m^2
STANDARD_DEVIATION 5.86 • n=5 Participants
Autism Diagnostic Observation Schedule (ADOS)
16.31 units on a scale
STANDARD_DEVIATION 12.04 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: One subject withdrew at the time of crossover.

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.

Outcome measures

Outcome measures
Measure
Nuedexta
n=13 Participants
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
n=12 Participants
Oral, one time daily for 7 days.
Change in Maladaptive Behaviors
-6.62 units on a scale
Standard Deviation 11.12
-1.08 units on a scale
Standard Deviation 8.46

PRIMARY outcome

Timeframe: Week 0 through week 25

Number of serious adverse events

Outcome measures

Outcome measures
Measure
Nuedexta
n=13 Participants
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
n=12 Participants
Oral, one time daily for 7 days.
Primary Safety Endpoints
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: One subject withdrew at the time of crossover.

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.

Outcome measures

Outcome measures
Measure
Nuedexta
n=13 Participants
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
n=12 Participants
Oral, one time daily for 7 days.
Change in Aggressive Behavior
-1.92 units on a scale
Standard Deviation 2.78
0.08 units on a scale
Standard Deviation 1.88

Adverse Events

Nuedexta

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Chez, MD

Sutter Medical Group, Neurology

Phone: (916) 454-6667

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place