A Phase 2 interventional study of Metadoxine (MG01CI) in ADHD, sponsored by Alcobra Ltd.. Completed at 2 sites in Israel. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-04-20.
Sponsored by Alcobra Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with ADHD.
Eligible subjects will be randomly assigned in a 1:1 ratio to one of two treatment groups, 1400 mg Metadoxine (MG01CI) and Placebo. The study will consist of three periods: a screening period of up to 2 weeks, a 6-week double-blind treatment period, and a 2-week safety follow-up period. The total duration of subject participation will be \~10 weeks.
Overview of Study Visits
Screening Period:
Visit 1 - Screening/Baseline Visit (up to 14 days prior to dosing)
Treatment Period:
Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 2 days Visit 4 - Day 14 ± 2 days Visit 5 - Day 28 ± 2 days Visit 6 - Day 42 ± 2 days
Follow-up period:
Visit 7 - Day 56 ± 3 days
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Alcobra Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Diagnosed with ADHD based on
Exclusion Criteria:
Pregnancy, lactation or inadequate contraceptive method
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Eligible subjects will be randomly assigned to receive MG01CI (1,400 mg)
Drug: Metadoxine (MG01CI)
Eligible subjects will be randomly assigned to receive Placebo (1,400 mg)
Drug: Metadoxine (MG01CI)
MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.
Also known as: Metadoxil
Conners' Adult ADHD Rating Scales (CAARS™)
The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 ('Not at all', 'never') to 3 ('Very much', 'very frequently'). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90
Time frame: 6 weeks (from visit 1 baseline to visit 6)
Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6)
The TOVA is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning. ADHD score is a comparison of the subject's response to the CPT test to those of an ADHD group, and is reported as a Z-score. An ADHD score of -1.80 and less fits the profile of the ADHD sample. A score of more than -1.80 (more positive) does not fit the ADHD profile. When comparing ADHD scores the higher the ADHD score the better the performance.
Time frame: 6 weeks( visit 1 baseline to visit 6)
Adult ADHD Quality of Life (AAQoL)- Measuring Change in Total Score of AAQoL From Visit 1 to Visit 6
The AAQoL scale provides a validated disease-specific measure of the impact of ADHD on quality of life.It is scored as an overall score (29 items) and four subscale scores: life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Individual items are scored on a five-point Likert-like scale from 'Not at all/Never' (1) to 'Extremely/Very Often' (5).
Time frame: 6 weeks (from visit 1 baseline to visit 6)
Clinical Global Impression Scale (CGI-I)Score
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 ('very much improved') through to 7 ('very much worse'). During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited.
Time frame: 6 weeks from visit 1 baseline to visit 6
subjects recruitment was done in two medical centers Geha and Rambam during Feb 2011-June 2011.
| Milestone | METADOXINE(MG01CI) | Placebo |
|---|---|---|
| Started | 60 | 60 |
| Completed | 57 | 56 |
| Not completed | 3 | 4 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Sponsor decision | 0 | 1 |
| Withdrew: Non compliance | 1 | 0 |
The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 ('Not at all', 'never') to 3 ('Very much', 'very frequently'). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90
| units on a scale | METADOXINE(MG01CI) | Placebo |
|---|---|---|
| Conners' Adult ADHD Rating Scales (CAARS™) | -12 ± 9.69 | -8.93 ± 9.26 |
The TOVA is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning. ADHD score is a comparison of the subject's response to the CPT test to those of an ADHD group, and is reported as a Z-score. An ADHD score of -1.80 and less fits the profile of the ADHD sample. A score of more than -1.80 (more positive) does not fit the ADHD profile. When comparing ADHD scores the higher the ADHD score the better the performance.
| Z score | METADOXINE(MG01CI) | Placebo |
|---|---|---|
| Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6) | 4.96 ± 8.86 | 3.01 ± 6.40 |
The AAQoL scale provides a validated disease-specific measure of the impact of ADHD on quality of life.It is scored as an overall score (29 items) and four subscale scores: life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Individual items are scored on a five-point Likert-like scale from 'Not at all/Never' (1) to 'Extremely/Very Often' (5).
| units on a scale | METADOXINE(MG01CI) | Placebo |
|---|---|---|
| Adult ADHD Quality of Life (AAQoL)- Measuring Change in Total Score of AAQoL From Visit 1 to Visit 6 | 10.93 ± 11.1 | 5.71 ± 15.82 |
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 ('very much improved') through to 7 ('very much worse'). During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited.
No measurements were reported for this outcome.
Collected over 8 weeks (from time of informed consent to end of study). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| METADOXINE(MG01CI) | — | 1/58 (1.7%) | 44/58 (75.9%) |
| Placebo | — | 0/59 (0%) | 41/59 (69.5%) |
| Event | METADOXINE(MG01CI) | Placebo |
|---|---|---|
| AppendicitisInfections and infestations | 1/58 | 0/59 |
| Neuroendocrine tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/58 | 0/59 |
| Event | METADOXINE(MG01CI) | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 17/58 | 23/59 |
| NauseaGastrointestinal disorders | 10/58 | 0/59 |
| Abdominal pain upperGastrointestinal disorders | 5/58 | 3/59 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 5/58 | 4/59 |
| Back painMusculoskeletal and connective tissue disorders | 4/58 | 3/59 |
| DysmenorrhoeaReproductive system and breast disorders | 2/58 | 4/59 |
| DizzinessNervous system disorders | 3/58 | 1/59 |
| FatigueGeneral disorders | 3/58 | 1/59 |
| Initial insomniaPsychiatric disorders | 3/58 | 0/59 |
| AstheniaGeneral disorders | 2/58 | 0/59 |
| Age, Categorical(Participants) | METADOXINE(MG01CI) | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 60 | 60 | 120 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | METADOXINE(MG01CI) | Placebo | Total |
|---|---|---|---|
| Female | 26 | 21 | 47 |
| Male | 34 | 39 | 73 |
| Region of Enrollment(participants) | METADOXINE(MG01CI) | Placebo | Total |
|---|---|---|---|
| Israel | 60 | 60 | 120 |
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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