Trial Outcomes & Findings for An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00337285)

Last Updated: 2012-08-20

Results Overview

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

349 participants

Primary outcome timeframe

up to one year

Results posted on

2012-08-20

Participant Flow

Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse for up to 1 year.

Participant milestones

Participant milestones
Measure	Vyvanse Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Overall Study STARTED	349
Overall Study COMPLETED	191
Overall Study NOT COMPLETED	158

Reasons for withdrawal

Reasons for withdrawal
Measure	Vyvanse Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Overall Study Withdrawal by Subject	42
Overall Study Lost to Follow-up	41
Overall Study Adverse Event	28
Overall Study Protocol Violation	27
Overall Study Lack of Efficacy	11
Overall Study Death	1
Overall Study Physician Decision	1
Overall Study Lack of protocol compliance	7

Baseline Characteristics

An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vyvanse n=349 Participants Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	349 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	35.8 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants
Region of Enrollment United States	349 participants n=5 Participants

PRIMARY outcome

Timeframe: up to one year

Population: Intent-to-treat (ITT). Defined as all subjects who were treated and had both the baseline and at least one post-baseline primary efficacy measurement (i.e., ADHD-RS-IV total score)

Outcome measures

Outcome measures
Measure	Vyvanse n=345 Participants Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Change in ADHD-RS-IV Total Score From Baseline at Up to One Year	-24.8 Units on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Up to 1 year

Population: ITT

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.

Outcome measures

Outcome measures
Measure	Vyvanse n=345 Participants Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Number of Participants With Improvement on CGI-I	290 Participants

SECONDARY outcome

Timeframe: up to 1 year

Population: Safety population (Defined as all subjects who were enrolled and who received at least one dose of the investigational product.)

Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.

Outcome measures

Outcome measures
Measure	Vyvanse n=349 Participants Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Change in PSQI Total Score From Baseline at Up to One Year	-1.3 Units on a scale Standard Deviation 2.8

Adverse Events

Vyvanse

Serious events: 8 serious events

Other events: 306 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vyvanse Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Musculoskeletal and connective tissue disorders Chest pain	0.29% 1/349
Gastrointestinal disorders Anal fissure	0.29% 1/349
Social circumstances Cocaine and alcohol toxicity	0.29% 1/349
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.29% 1/349
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.29% 1/349
Injury, poisoning and procedural complications Foot fracture	0.29% 1/349
Hepatobiliary disorders Cholecystitis acute	0.29% 1/349
Infections and infestations Arthritis bacterial	0.29% 1/349

Other adverse events

Other adverse events
Measure	Vyvanse Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
Infections and infestations Upper respiratory tract infection	21.8% 76/349
Psychiatric disorders Insomnia	19.5% 68/349
Nervous system disorders Headache	17.2% 60/349
Gastrointestinal disorders Dry mouth	16.6% 58/349
Metabolism and nutrition disorders Decreased appetite	14.3% 50/349
General disorders Irritability	11.2% 39/349
Psychiatric disorders Anxiety	8.3% 29/349
Infections and infestations Nasopharyngitis	7.4% 26/349
Infections and infestations Sinusitis	6.6% 23/349
Investigations Weight decreased	6.0% 21/349
Musculoskeletal and connective tissue disorders Back pain	5.4% 19/349
Musculoskeletal and connective tissue disorders Muscle spasms	5.2% 18/349

Additional Information

Timothy Whitaker

Shire Pharmaceutical Development, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER