Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 439 for:    Methylphenidate

Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methylphenidate Extended-release Liquid
Hide 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
Arm/Group Title Methylphenidate Extended-release Liquid
Hide 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
Hide 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
15
1.Primary Outcome
Title Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Extended-release Liquid
Hide 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)
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
Hide Arm/Group Description Methylphenidate extended-release liquid formulation
All-Cause Mortality
Methylphenidate Extended-release Liquid
Affected / at Risk (%)
Total   0/15 (0.00%)    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Layout table for additonal information
Responsible Party: Gagan Joshi, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02096952     History of Changes
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