Trial Outcomes & Findings for A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD (NCT NCT02255513)

NCT ID: NCT02255513

Last Updated: 2021-06-30

Results Overview

Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day. The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 43 participants
• Primary outcome timeframe: 8-hours from 8:00 am to 4:00 pm
• Results posted on: 2021-06-30

Participant Flow

Participant milestones

Measure	HLD200 HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening.	Placebo Placebo capsules (dose matched to HLD200 capsules) Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening.
Open-label, Treatment Optimization STARTED	43	0
Open-label, Treatment Optimization COMPLETED	43	0
Open-label, Treatment Optimization NOT COMPLETED	0	0
Double Blind, Placebo-controlled STARTED	22	21
Double Blind, Placebo-controlled COMPLETED	22	21
Double Blind, Placebo-controlled NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

Baseline characteristics by cohort

Measure	HLD200 n=22 Participants Double-blind, optimal dose of HLD200 for 7 days	Placebo n=21 Participants Double-blind, placebo for 7 days	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.8 years STANDARD_DEVIATION 1.72 • n=5 Participants	9.5 years STANDARD_DEVIATION 1.81 • n=7 Participants	9.7 years STANDARD_DEVIATION 1.75 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 8-hours from 8:00 am to 4:00 pm

Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day.

The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day.

Outcome measures

Measure	HLD200 n=22 Participants Double-blind, optimal dose of HLD200 for 7 days	Placebo n=21 Participants Double-blind, placebo for 7 days
SKAMP	11.8 SKAMP Combined Score Standard Deviation 1.63	18.9 SKAMP Combined Score Standard Deviation 1.67

Adverse Events

HLD200

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HLD200 n=22 participants at risk Double-blind, optimal dose of HLD200 for 7 days	Placebo n=21 participants at risk Double-blind, placebo for 7 days
Nervous system disorders Headache	9.1% 2/22 • Number of events 2 • 1 Week (Double-blind Phase)	9.5% 2/21 • Number of events 2 • 1 Week (Double-blind Phase)
Cardiac disorders Bundle branch block right	4.5% 1/22 • Number of events 1 • 1 Week (Double-blind Phase)	0.00% 0/21 • 1 Week (Double-blind Phase)
Gastrointestinal disorders Abdominal pain upper	4.5% 1/22 • Number of events 1 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 1 • 1 Week (Double-blind Phase)
Gastrointestinal disorders Nausea	4.5% 1/22 • Number of events 1 • 1 Week (Double-blind Phase)	0.00% 0/21 • 1 Week (Double-blind Phase)
Gastrointestinal disorders Vomiting	4.5% 1/22 • Number of events 1 • 1 Week (Double-blind Phase)	0.00% 0/21 • 1 Week (Double-blind Phase)
Infections and infestations Gastroenteritis viral	4.5% 1/22 • Number of events 1 • 1 Week (Double-blind Phase)	0.00% 0/21 • 1 Week (Double-blind Phase)
Injury, poisoning and procedural complications Contusion	0.00% 0/22 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 1 • 1 Week (Double-blind Phase)
Injury, poisoning and procedural complications Fall	4.5% 1/22 • Number of events 1 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 1 • 1 Week (Double-blind Phase)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.5% 1/22 • Number of events 1 • 1 Week (Double-blind Phase)	0.00% 0/21 • 1 Week (Double-blind Phase)
Psychiatric disorders Emotional disorder	0.00% 0/22 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 2 • 1 Week (Double-blind Phase)
Psychiatric disorders Initial insomnia	0.00% 0/22 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 2 • 1 Week (Double-blind Phase)
Psychiatric disorders Insomnia	0.00% 0/22 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 1 • 1 Week (Double-blind Phase)
Renal and urinary disorders Urinary incontinence	0.00% 0/22 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 1 • 1 Week (Double-blind Phase)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/22 • 1 Week (Double-blind Phase)	4.8% 1/21 • Number of events 1 • 1 Week (Double-blind Phase)

Additional Information

Chief Scientific Officer

Ironshore Pharmaceuticals and Development, Inc.

Phone: 13457498174

Email: bev@ironshorepharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place