Status:
COMPLETED
Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Alcobra Ltd.
Conditions:
ADHD
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
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
Detailed Description
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 tr...
Eligibility Criteria
Inclusion
- Adult males and females, 18 to 50 years old, inclusive, at screening visit
- Diagnosed with ADHD based on
- DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS V1.2)
- SCID clinical interview
- Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
- Female subjects with childbearing potential must agree to use effective contraceptive and have negative urine pregnancy test at screening visit
- Able to attend the clinic regularly and reliably
- Able to swallow tablets/capsules
- Able to understand, read, write and speak Hebrew fluently to complete study related materials
- Able to understand and sign written informed consent to participate in the study
Exclusion
- Subjects who were non-responder to at least two ADHD treatments
- Subjects with any medical or psychiatric condition (e.g. schizophrenia, personality disorder as diagnosed by DSM-IV) or clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by medical history, physical examination, neurological exam, laboratory tests or ECG or based on the opinion of the Investigator; common diseases such as hypertension, type 2 diabetes mellitus, hyperlipidemia, etc. are allowed per the Investigator's judgment, as long as they are stable and controlled by medical therapy that is constant for at least 8 weeks prior to randomization and throughout the study
- Any prescription or non-prescription ADHD medications during the 7 days prior to the screening visit
- Known or suspected HIV-positive or with advanced diseases such as AIDS, Hepatitis C, Hepatitis B or tuberculosis
- History of allergy or sensitivity to B complex vitamins
- History or suspicion of PDD, NLD or other psychotic conditions
- Use of Vitamin B throughout the study
- Use of ADHD medications throughout the study
- Use of any psychiatric medications throughout the study
- Use of investigational medication/treatment in the past 30 days prior to the screening visit per the discretion of the Investigator
- Use of any medication or food supplement not considered acceptable by the clinical Investigator or the medical monitor during the 14-day period before randomization
- Current (or history within the last 6 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine). Subjects should also agree to refrain from consuming abnormally high amounts of caffeine during the study.
- Suicidality, defined as either active suicidal plan/intent or active suicidal thoughts, in the 6 months before the Screening Visit or no lifetime suicide attempt.
- Blind subjects
- Any relation to the Sponsor, Investigator or study staff
- Any condition, which in the opinion of the Principal Investigator would place the subject at risk or influence the conduct of the study or interpretation of results, including (but not limited to) abnormally low intellectual capacity.
- Subjects who cannot fully comprehend the implications of the protocol or comply with its requirements or are capable to follow the study schedule for any reason
- Pregnancy, lactation or inadequate contraceptive method
- \-
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01243242
Start Date
February 1 2011
End Date
September 1 2011
Last Update
April 20 2012
Active Locations (2)
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1
Cognitive Neurology unit Rambam Health Care Campus
Haifa, Israel
2
ADHD Unit, Geha Mental Health Center
Petah Tikva, Israel