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Trial Outcomes & Findings for Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism (NCT NCT01039792)

NCT ID: NCT01039792

Last Updated: 2017-02-24

Results Overview

PI assesses subject's change using the CGI-I measure. This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

57 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-02-24

Participant Flow

Children were recruited from the Autism clinic, an advertisement on Craigslist.org and letters to families of current and previous patients, between 12/8/10 to 10/22/13.

Enrolled patients excluded from the trial prior to assignment phase were attributed to inattention/inability to focus, increased hyperactivity/stimming, lack of efficacy, challenging behavior- parent request to drop out

Participant milestones

Participant milestones
Measure
Placebo
Placebo Placebo: placebo
Active
Active Methyl B12 Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days
Overall Study
STARTED
29
28
Overall Study
COMPLETED
23
27
Overall Study
NOT COMPLETED
6
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=23 Participants
Placebo Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid
Active
n=27 Participants
Active Methyl B12 Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days
Total
n=50 Participants
Total of all reporting groups
Age, Categorical
<=18 years
23 Participants
n=5 Participants
27 Participants
n=7 Participants
50 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
58 months
STANDARD_DEVIATION 14 • n=5 Participants
67 months
STANDARD_DEVIATION 16 • n=7 Participants
63 months
STANDARD_DEVIATION 16 • n=5 Participants
Gender
Female
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
Gender
Male
19 Participants
n=5 Participants
21 Participants
n=7 Participants
40 Participants
n=5 Participants
Region of Enrollment
United States
23 Participants
n=5 Participants
27 Participants
n=7 Participants
50 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: comparing placebo vs active B12 subjects

PI assesses subject's change using the CGI-I measure. This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=23 Participants
Placebo Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid
Active
n=27 Participants
Active Methyl B12 Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days
Clinical Global Impression-Improvement (CGI-I)
3.1 CGI- Improvement
Standard Deviation 0.8
2.4 CGI- Improvement
Standard Deviation 0.8

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Active

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=23 participants at risk；n=24 participants at risk
Placebo Placebo: placebo
Active
n=27 participants at risk
Active Methyl B12 Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days
Respiratory, thoracic and mediastinal disorders
cold
8.7%
2/23 • Number of events 2
11.1%
3/27 • Number of events 3
General disorders
fever
4.3%
1/23 • Number of events 1
7.4%
2/27 • Number of events 2
Psychiatric disorders
increased hyperactivity
30.4%
7/23 • Number of events 7
7.4%
2/27 • Number of events 2
General disorders
mouthing
4.3%
1/23 • Number of events 1
18.5%
5/27 • Number of events 5
General disorders
trouble sleeping
13.0%
3/23 • Number of events 3
3.7%
1/27 • Number of events 1

Additional Information

Dr. Robert Hendren

UCSF

Phone: 415-502-3500

Results disclosure agreements

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