Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD

• ClinicalTrials.gov Identifier: NCT02096952
• Recruitment Status: Completed
• First Posted: March 26, 2014
• Results First Posted: February 23, 2018
• Last Update Posted: February 23, 2018
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Gagan Joshi, Massachusetts General Hospital

Tracking Information

• First Submitted Date: March 24, 2014
• First Posted Date: March 26, 2014
• Results First Submitted Date: January 24, 2018
• Results First Posted Date: February 23, 2018
• Last Update Posted Date: February 23, 2018
• Study Start Date: May 2014
• Actual Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 21, 2018)

Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score [ Time Frame: Baseline to 6 weeks ]

The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54. The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score.

Original Primary Outcome Measures (submitted: March 25, 2014)

Adult ADHD Investigator Symptom Report Scale (AISRS) [ Time Frame: 6 weeks ]

The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD
• Official Title: Open-Label Treatment Trial to Assess the Short-Term Tolerability, Safety, and Efficacy of Methylphenidate Hydrochloride Extended-Release Liquid Formulation in High-Functioning Autism Spectrum Disorder Adults With Attention-Deficit/Hyperactivity Disorder
• Brief Summary: The purpose of this study is to determine whether methylphenidate hydrochloride extended release liquid formulation is safe and effective in the treatment of attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism spectrum disorders (ASD).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Attention-deficit/Hyperactivity Disorder
• Autism Spectrum Disorder

Intervention

Drug: Methylphenidate extended-release liquid formulation

Other Name: Quillivant extended release

Study Arms

Experimental: Methylphenidate extended-release liquid

Methylphenidate extended-release liquid formulation

Intervention: Drug: Methylphenidate extended-release liquid formulation

• Publications *: Joshi G, DiSalvo M, Wozniak J, Ceranoglu TA, Yule A, Surman C, Fried R, Galdo M, Hoskova B, Belser A, Biederman J. A prospective open-label trial of long-acting liquid methylphenidate for the treatment of attention deficit/hyperactivity disorder in intellectually capable adults with autism spectrum disorder. World J Biol Psychiatry. 2020 Apr;21(4):274-290. doi: 10.1080/15622975.2019.1679392. Epub 2019 Dec 19.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 21, 2018): 15
• Original Estimated Enrollment (submitted: March 25, 2014): 40
• Actual Study Completion Date: January 2018
• Actual Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

• Male or female participants between 18 and 40 years of age (inclusive)
• Fulfills DSM-5 diagnostic criteria for autism spectrum disorder as established by the clinical diagnostic interview and ADOS
• Fulfills DSM-5 diagnostic criteria for ADHD as established by the clinical diagnostic interview and confirmed by the K-SADS-E ADHD module
• Participants with at least moderately severe symptoms of ASD as demonstrated by SRS raw score ≥ 85 and CGI-ASD severity score ≥ 4
• Participants with at least moderately severe symptoms of ADHD as assessed by AISRS score ≥ 24 and CGI-ADHD severity score ≥ 4
• Participants and/or their legal representative must understand the nature of the study. Participants and/or their legal representative must sign an IRB-approved informed consent form before initiation of any study procedures.
• Participants and/or their legal representative must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
• Participant must be able to participate in mandatory blood draws.
• Participant with major mood and/or anxiety disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria

• Impaired intellectual capacity (IQ <85)
• Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills)
• Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days).
• Subjects currently (within past 30 days) experiencing significant features of anxiety, mood, or psychotic disorder as indicated by a >3 score on the disorder-specific Clinical Global Impression-Severity (CGI-S) clinician-rated scale.
• History of substance use (except nicotine or caffeine) within past 3 months (inclusive) or with urine drug screen positive for substances of abuse
• Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
• Pregnant or nursing females or females with a positive beta-HCG pregnancy test.
• Uncorrected hypothyroidism or hyperthyroidism.
• History of non-febrile seizures within last 1 month without a clear and resolved etiology.
• History of renal or hepatic impairment.
• Glaucoma
• Tourette's syndrome and/or motor tics
• Serious, unstable systemic illness
• Personal history of cardiac disease or a family history of non-geriatric cardiac disease or death
• Clinically significant abnormal baseline laboratory values which include the following:
• Values more than 20% above the upper range of the laboratory standard for a basic metabolic screen.
• Systolic and diastolic blood pressure parameters above 140 and 90, respectively.
• Resting heart rate outside of 60-100 bpm.
• Abnormal ECG parameters defined as QTC> 460msec, QRS>120 msec, and/or PR>200 msec.
• ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
• Participant with a history of non-response to adequate trial of methylphenidate (therapeutic dose for an adequate duration) as determined by clinician.
• History of intolerance or an allergic reaction to methylphenidate.
• Current or recent treatment (within the past 30 days) with current stimulant class of anti-ADHD medications.
• Current treatment with monoamine oxidase inhibitors (MAOIs)
• Current treatment with a first- or second-generation antipsychotic medication on a dose that has not been stable for at least 4 weeks prior to baseline visit.
• Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to baseline visit.
• Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.

While stably treated or remitted hypertension is not exclusionary, any subject with a history of high blood pressure will be asked to obtain approval from their primary care physician certifying that their hypertension is stable and that they may safely begin stimulant therapy. Subjects will be informed of the cardiovascular risks of MPH, and any subject with a history of hypertension who is unwilling to consult with their current treater-or to grant study staff permission to consult with the subject's current treater-will be excluded because of the potential risks to subject safety. Per the FDA approved MPH-ERLF package insert, high blood pressure is not a contraindication of MPH therapy; however, due to the cardiovascular side effects, it is recommended that subjects with a history of high blood pressure be monitored carefully. Cardiovascular risk factors are carefully monitored throughout the study for all subjects by way of screening electrocardiograms and pulse/blood pressure readings at every office visit. Patients with current untreated hypertension are not eligible.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02096952
• Other Study ID Numbers: 2014P000501
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gagan Joshi, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gagan Joshi, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: February 2018