Trial Outcomes & Findings for A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity ) (NCT NCT02059642)

NCT ID: NCT02059642

Last Updated: 2017-03-28

Results Overview

Primary efficacy endpoint: change from Baseline in the total ADHD symptom score with adult prompts of the CAARS-Inv. The CAARS is a scale to assess the presence and severity of ADHD symptoms and behaviors in adults. During an interview with the investigator, subject rates items pertaining to their behavior using a 4-point Likert-style format ranging from 0 ('Not at all') to 3 ('Very much). The scale measures ADHD symptoms across clinically significant domains using a 30 item questionnaire, while examining the manifestations of those symptoms. The scale includes an assessment of 9 inattentive symptoms (Subset A) and 9 hyperactive \& impulsive symptoms (Subset B). The total ADHD symptom score, Subset C (the sum of the inattentive symptom scores from Subset A and the hyperactive \& impulsive symptoms from Subset B) is the primary outcome measure. Scores of the scale for Subset C, comprised of scores from 18 questions,range from 0 (no ADHD symptoms) to 54, highest rating of ADHD symptoms.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

300 participants

Primary outcome timeframe

baseline, 6 weeks

Results posted on

2017-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily placebo: Placebo 1400 mg administered orally once daily	MG01CI (1400 mg) MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
Overall Study STARTED	148	152
Overall Study COMPLETED	121	128
Overall Study NOT COMPLETED	27	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=146 Participants Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily placebo: Placebo 1400 mg administered orally once daily	MG01CI (1400 mg) n=152 Participants MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily	Total n=298 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	146 Participants n=5 Participants	152 Participants n=7 Participants	298 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	35.6 years STANDARD_DEVIATION 10.42 • n=5 Participants	35.1 years STANDARD_DEVIATION 9.93 • n=7 Participants	35.4 years STANDARD_DEVIATION 10.16 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	79 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	73 Participants n=7 Participants	140 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	131 Participants n=5 Participants	141 Participants n=7 Participants	272 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	130 Participants n=5 Participants	128 Participants n=7 Participants	258 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants	108 participants n=7 Participants	213 participants n=5 Participants
Region of Enrollment Israel	41 participants n=5 Participants	44 participants n=7 Participants	85 participants n=5 Participants
BMI	28.243 "kg/m^2" STANDARD_DEVIATION 6.3923 • n=5 Participants	28.345 "kg/m^2" STANDARD_DEVIATION 27.230 • n=7 Participants	28.295 "kg/m^2" STANDARD_DEVIATION 6.3393 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 weeks

Population: Intent to Treat

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily placebo: Placebo 1400 mg administered orally once daily	MG01CI (1400 mg) n=151 Participants MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks	-9.9 Change in Score from Baseline Interval -11.89 to -7.92	-12.0 Change in Score from Baseline Interval -13.95 to -10.06

SECONDARY outcome

Timeframe: 6 weeks

Population: Safety population

Safety assessments will be based on changes from Baseline of clinical AEs reported by the subject or observed by the Investigator and concomitant medication use, treatment adherence (eg, dropouts due to AEs)

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily placebo: Placebo 1400 mg administered orally once daily	MG01CI (1400 mg) n=152 Participants MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events	66.4 Percentage of participants with TEAEs	56.8 Percentage of participants with TEAEs

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

MG01CI (1400 mg)

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=146 participants at risk Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily placebo: Placebo 1400 mg administered orally once daily	MG01CI (1400 mg) n=152 participants at risk MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
Infections and infestations APPENDICITIS	0.68% 1/146 • Number of events 1 • 7 months	0.00% 0/152 • 7 months

Other adverse events

Other adverse events
Measure	Placebo n=146 participants at risk Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily placebo: Placebo 1400 mg administered orally once daily	MG01CI (1400 mg) n=152 participants at risk MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
Gastrointestinal disorders NAUSEA	6.2% 9/146 • Number of events 9 • 7 months	8.6% 13/152 • Number of events 13 • 7 months
General disorders FATIGUE	8.2% 12/146 • Number of events 12 • 7 months	7.2% 11/152 • Number of events 11 • 7 months
Metabolism and nutrition disorders DECREASED APPETITE	1.4% 2/146 • Number of events 2 • 7 months	5.3% 8/152 • Number of events 8 • 7 months
Nervous system disorders HEADACHE	12.3% 18/146 • Number of events 18 • 7 months	15.1% 23/152 • Number of events 23 • 7 months

Additional Information

Dr. Jonathan Rubin

Alcobra

Phone: 610-940-1631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee "Publication of the Study results in scientific literature is encouraged, but any publication should require gaining prior approval from the Company and the Company reserves the right to review any paper written utilizing data generated from the Study before such paper is presented or submitted for publication".
Publication restrictions are in place

Restriction type: OTHER