Trial Outcomes & Findings for Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD (NCT NCT00780208)

Last Updated: 2018-06-14

Results Overview

Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2018-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Daytrana (Methylphenidate Patch) Methylphenidate patch Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
Overall Study STARTED	14
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daytrana (Methylphenidate Patch) n=14 Participants Methylphenidate patch Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	Daytrana (Methylphenidate Patch) n=14 Participants Methylphenidate patch Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
ADHD Symptom Severity	-17.93 units on a scale Standard Deviation 5.89

SECONDARY outcome

Timeframe: 8 weeks

Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens

Outcome measures

Outcome measures
Measure	Daytrana (Methylphenidate Patch) n=14 Participants Methylphenidate patch Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
Number of Participants With Positive Drug Screen	4 Participants

Adverse Events

Daytrana (Methylphenidate Patch)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Daytrana (Methylphenidate Patch) n=14 participants at risk Methylphenidate patch Daytrana (methylphenidate patch): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
Skin and subcutaneous tissue disorders Skin reaction	57.1% 8/14 • Number of events 9
Musculoskeletal and connective tissue disorders Muscle cramps	7.1% 1/14 • Number of events 1
General disorders Headache	28.6% 4/14 • Number of events 5
Respiratory, thoracic and mediastinal disorders Sinus/cold/allergies	7.1% 1/14 • Number of events 1
General disorders Dry mouth	14.3% 2/14 • Number of events 2
Skin and subcutaneous tissue disorders Canker sores	7.1% 1/14 • Number of events 1
General disorders Paresthesia	7.1% 1/14 • Number of events 2
General disorders Insomnia	7.1% 1/14 • Number of events 1
Psychiatric disorders Hyperactivity	7.1% 1/14 • Number of events 1
Psychiatric disorders Depression	7.1% 1/14 • Number of events 1
General disorders Dehydration	7.1% 1/14 • Number of events 1
Infections and infestations Yeast infection	7.1% 1/14 • Number of events 1
General disorders Tooth pain	7.1% 1/14 • Number of events 1
General disorders Hot flash	7.1% 1/14 • Number of events 1

Additional Information

Aimee McRae-Clark, Professor

Medical University of South Carolina

Phone: 843-792-5216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place