Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD

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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:

Information provided by (Responsible Party):

Gagan Joshi, Massachusetts General Hospital

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Attention-deficit/Hyperactivity Disorder Autism Spectrum Disorder
Intervention	Drug: Methylphenidate extended-release liquid formulation
Enrollment	15

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Methylphenidate Extended-release Liquid
Arm/Group Description	Methylphenidate extended-release li...
Arm/Group Description	Methylphenidate extended-release liquid formulation (MPH-ERLF) The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability.
Period Title: Overall Study
Started	15
Completed	14
Not Completed	1
Reason Not Completed
Adverse Event	1

Baseline Characteristics

Arm/Group Title		Methylphenidate Extended-release Liquid
Arm/Group Description		Methylphenidate extended-release li...
Arm/Group Description		Methylphenidate extended-release liquid formulation (MPH-ERLF) The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability.
Overall Number of Baseline Participants		15
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	15 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	15 100.0%
	>=65 years	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	15 participants
		24.9 (4.6)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	15 participants
	Female	3 20.0%
	Male	12 80.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	15 participants
	Hispanic or Latino	1 6.7%
	Not Hispanic or Latino	14 93.3%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	15 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	14 93.3%
	More than one race	0 0.0%
	Unknown or Not Reported	1 6.7%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	15 participants
United States		15

Outcome Measures

1.Primary Outcome


Title	Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
Description	The Adult ADHD Investiga...
Description	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.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Methylphenidate Extended-release Liquid
Arm/Group Description:	Methylphenidate extended-release li...
Arm/Group Description:	Methylphenidate extended-release liquid formulation
Overall Number of Participants Analyzed	15
Mean (Standard Deviation) Unit of Measure: units on a scale
	-22.8 (8.8)

Adverse Events

Time Frame	Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Methylphenidate Extended-release Liquid
Arm/Group Description	Methylphenidate extended-release li...
Arm/Group Description	Methylphenidate extended-release liquid formulation
All-Cause Mortality
	Methylphenidate Extended-release Liquid
	Affected / at Risk (%)
Total	0/15 (0.00%)
Serious Adverse Events Serious Adverse Events
	Methylphenidate Extended-release Liquid
	Affected / at Risk (%)	# Events
Total	1/15 (6.67%)
Psychiatric disorders
Suicide attempt ^†	1/15 (6.67%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Methylphenidate Extended-release Liquid
	Affected / at Risk (%)	# Events
Total	13/15 (86.67%)
Blood and lymphatic system disorders
High blood pressure ^†	2/15 (13.33%)	2
Cardiac disorders
Tachycardia ^†	2/15 (13.33%)	2
Heart racing ^†	1/15 (6.67%)	2
Palpitations ^†	1/15 (6.67%)	2
Gastrointestinal disorders
Nausea ^†	2/15 (13.33%)	5
General disorders
Headache ^†	8/15 (53.33%)	21
Difficulty falling asleep ^†	3/15 (20.00%)	5
Fatigue ^†	2/15 (13.33%)	4
Dizziness ^†	1/15 (6.67%)	1
Lightheadedness ^†	1/15 (6.67%)	1
Chest pressure ^†	1/15 (6.67%)	1
Infections and infestations
Flu ^†	1/15 (6.67%)	1
Toothache ^†	1/15 (6.67%)	1
Sinus issues ^†	1/15 (6.67%)	1
Metabolism and nutrition disorders
Decreased appetite ^†	4/15 (26.67%)	11
Musculoskeletal and connective tissue disorders
Back pain ^†	1/15 (6.67%)	1
Foot pain ^†	1/15 (6.67%)	2
Jaw pain ^†	1/15 (6.67%)	1
Psychiatric disorders
Insomnia ^†	5/15 (33.33%)	11
Anxiety ^†	5/15 (33.33%)	8
Irritability ^†	3/15 (20.00%)	3
Suicidal ideation ^†	2/15 (13.33%)	2
Depressed mood ^†	1/15 (6.67%)	1
Jittery and tense ^†	1/15 (6.67%)	1
Skin and subcutaneous tissue disorders
Sweaty hands ^†	1/15 (6.67%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Gahan Joshi
Organization:	Massachusetts General Hospital
Phone:	617-726-8392
EMail:	joshi.gagan@mgh.harvard.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Gagan Joshi, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT02096952
Other Study ID Numbers:	2014P000501
First Submitted:	March 24, 2014
First Posted:	March 26, 2014
Results First Submitted:	January 24, 2018
Results First Posted:	February 23, 2018
Last Update Posted:	February 23, 2018

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