Trial Outcomes & Findings for SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder (NCT NCT00985725)

Last Updated: 2021-06-08

Results Overview

BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

143 participants

Primary outcome timeframe

Baseline and week 9

Results posted on

2021-06-08

Participant Flow

Subjects clinically stable on an anti-depressant were randomized (1:1) to LDX or placebo augmentation for 9 weeks. Double-blind LDX or placebo was administered orally as adjunctive therapy (20 to 70 mg per day, titrated over the initial 6 weeks), with the optimal individual dose being continued during a 3-week dose maintenance period.

Participant milestones

Participant milestones
Measure	Lisdexamfetamine Dimesylate (LDX) Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo Administered orally once-daily for 9 weeks.
Overall Study STARTED	71	72
Overall Study COMPLETED	60	59
Overall Study NOT COMPLETED	11	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Lisdexamfetamine Dimesylate (LDX) Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo Administered orally once-daily for 9 weeks.
Overall Study Adverse Event	4	1
Overall Study Protocol Violation	1	3
Overall Study Withdrawal by Subject	4	4
Overall Study Lost to Follow-up	1	1
Overall Study Lack of Efficacy	0	1
Overall Study Non-compliance	1	2
Overall Study Out-of-window visits	0	1

Baseline Characteristics

SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.	Total n=143 Participants Total of all reporting groups
Age, Continuous	41.9 years STANDARD_DEVIATION 9.79 • n=5 Participants	39.5 years STANDARD_DEVIATION 10.59 • n=7 Participants	40.7 years STANDARD_DEVIATION 10.23 • n=5 Participants
Age, Customized 18 to 39 years	28 Participants n=5 Participants	34 Participants n=7 Participants	62 Participants n=5 Participants
Age, Customized 40 to 55 years	43 Participants n=5 Participants	38 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	48 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	71 Participants n=5 Participants	72 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 9

Population: The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)	-21.2 T-scores Standard Error 1.67	-13.2 T-scores Standard Error 1.66

SECONDARY outcome

Timeframe: Baseline and week 9

Population: FAS

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)	-5.0 Scores on a scale Standard Error 0.66	-3.1 Scores on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline and week 9

Population: FAS

BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Behavioral recognition index	-17.4 T-scores Standard Error 1.51	-12.3 T-scores Standard Error 1.50
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Inhibit subscale	-13.5 T-scores Standard Error 1.26	-9.3 T-scores Standard Error 1.25
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Shift subscale	-16.2 T-scores Standard Error 1.51	-10.6 T-scores Standard Error 1.50
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Emotional control subscale	-13.8 T-scores Standard Error 1.48	-10.1 T-scores Standard Error 1.47
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Self-monitor subscale	-13.8 T-scores Standard Error 1.36	-10.7 T-scores Standard Error 1.35
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Metacognition index	-21.1 T-scores Standard Error 1.67	-12.2 T-scores Standard Error 1.66
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Initiate subscale	-19.4 T-scores Standard Error 1.57	-10.8 T-scores Standard Error 1.56
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Working memory subscale	-20.1 T-scores Standard Error 1.65	-11.0 T-scores Standard Error 1.64
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Plan/Organize subscale	-18.7 T-scores Standard Error 1.58	-11.3 T-scores Standard Error 1.57
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Task monitor subscale	-16.8 T-scores Standard Error 1.63	-11.9 T-scores Standard Error 1.62
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF Organization of materials subscale	-15.2 T-scores Standard Error 1.49	-8.2 T-scores Standard Error 1.48

SECONDARY outcome

Timeframe: Baseline and up to 9 weeks/Endpoint

Population: FAS

This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores \< 70 indicate likely deficit and impairment, and scores \> 110 indicate high function and capacity. Higher scores are better.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint Complex information speed processing index	8.7 Response scores Standard Deviation 10.13	3.7 Response scores Standard Deviation 9.02
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint Executive function index	11.0 Response scores Standard Deviation 14.80	6.0 Response scores Standard Deviation 14.43
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint Neurocognitive index	11.5 Response scores Standard Deviation 17.14	2.5 Response scores Standard Deviation 13.74

SECONDARY outcome

Timeframe: Baseline

Population: FAS

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Normal, not at all ill	0.0 percentage of participants	2.8 percentage of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Borderline mentally ill	7.0 percentage of participants	8.3 percentage of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Mildly ill	42.3 percentage of participants	36.1 percentage of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Moderately ill	45.1 percentage of participants	48.6 percentage of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Markedly ill	4.2 percentage of participants	4.2 percentage of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Severely ill	1.4 percentage of participants	0.0 percentage of participants
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline Among the most extremely ill	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 9 weeks/Endpoint

Population: FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=69 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=69 Participants Administered orally once-daily for 9 weeks.
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint Normal, not at all ill	21.7 percentage of participants	15.9 percentage of participants
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint Borderline mentally ill	40.6 percentage of participants	23.2 percentage of participants
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint Mildly ill	20.3 percentage of participants	24.6 percentage of participants
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint Moderately ill	14.5 percentage of participants	34.8 percentage of participants
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint Markedly ill	2.9 percentage of participants	1.4 percentage of participants
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint Severely ill	0.0 percentage of participants	0.0 percentage of participants
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint Among the most extremely ill	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 9

Population: FAS

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF	60.6 percentage of participants	38.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and up to 9 weeks/Endpoint

The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=46 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=43 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint	-20.4 Scores on a scale Standard Error 2.24	-15.9 Scores on a scale Standard Error 2.32

SECONDARY outcome

Timeframe: Baseline and week 9

Population: The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.

This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=20 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=21 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF	2.5 Scores on a scale Standard Deviation 4.61	2.4 Scores on a scale Standard Deviation 5.34

SECONDARY outcome

Timeframe: Baseline and week 9

Population: Only the females from the SAS population were used and not all of them completed this outcome assessment.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=48 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=46 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF	2.7 Scores on a scale Standard Deviation 8.47	1.6 Scores on a scale Standard Deviation 5.60

SECONDARY outcome

Timeframe: Baseline and week 9

The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=66 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=66 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 Aggregate physical	-0.10 Scores on a scale Standard Deviation 0.461	-0.23 Scores on a scale Standard Deviation 0.473
Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 Aggregate mental	0.69 Scores on a scale Standard Deviation 0.987	0.63 Scores on a scale Standard Deviation 0.807

SECONDARY outcome

Timeframe: Baseline and up to 9 weeks/Endpoint

The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=68 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=69 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint Physical health activities	17.9 Scores on a scale Standard Deviation 20.03	8.2 Scores on a scale Standard Deviation 16.82
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint Overall life satisfaction	12.1 Scores on a scale Standard Deviation 25.37	9.1 Scores on a scale Standard Deviation 22.27

SECONDARY outcome

Timeframe: Baseline and week 11

Population: SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.

ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=59 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=58 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11	-9.4 Scores on a scale Standard Deviation 14.43	-5.9 Scores on a scale Standard Deviation 10.86

SECONDARY outcome

Timeframe: Baseline and week 9

Population: SAS

The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF	-4.4 Scores on a scale Standard Deviation 5.81	-3.8 Scores on a scale Standard Deviation 5.43

SECONDARY outcome

Timeframe: Baseline and week 9

The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine Dimesylate (LDX) n=63 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=59 Participants Administered orally once-daily for 9 weeks.
Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9	-0.1 Scores on a scale Standard Deviation 0.40	0.0 Scores on a scale Standard Deviation 0.13

Adverse Events

Lisdexamfetamine Dimesylate (LDX)

Serious events: 2 serious events

Other events: 56 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 participants at risk Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 participants at risk Administered orally once-daily for 9 weeks.
Nervous system disorders Loss of consciousness	1.4% 1/71	0.00% 0/72
Psychiatric disorders Suicidal ideation	1.4% 1/71	0.00% 0/72
Infections and infestations Gastroenteritis	0.00% 0/71	1.4% 1/72
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/71	1.4% 1/72
Infections and infestations Salmonellosis	0.00% 0/71	1.4% 1/72
Infections and infestations Pelvic inflammatory disease	0.00% 0/71	1.4% 1/72

Other adverse events

Other adverse events
Measure	Lisdexamfetamine Dimesylate (LDX) n=71 participants at risk Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.	Placebo n=72 participants at risk Administered orally once-daily for 9 weeks.
Ear and labyrinth disorders Hyperacusis	2.8% 2/71	0.00% 0/72
Gastrointestinal disorders Abdominal pain	1.4% 1/71	2.8% 2/72
Gastrointestinal disorders Constipation	2.8% 2/71	0.00% 0/72
Gastrointestinal disorders Diarrhea	2.8% 2/71	5.6% 4/72
Gastrointestinal disorders Dry mouth	15.5% 11/71	8.3% 6/72
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/71	4.2% 3/72
Gastrointestinal disorders Nausea	7.0% 5/71	5.6% 4/72
Gastrointestinal disorders Vomiting	0.00% 0/71	2.8% 2/72
General disorders Fatigue	5.6% 4/71	5.6% 4/72
General disorders Feeling jittery	2.8% 2/71	1.4% 1/72
General disorders Irritability	12.7% 9/71	6.9% 5/72
Infections and infestations Nasopharyngitis	2.8% 2/71	2.8% 2/72
Infections and infestations Sinusitis	1.4% 1/71	5.6% 4/72
Infections and infestations Upper respiratory tract infection	8.5% 6/71	5.6% 4/72
Infections and infestations Urinary tract infection	9.9% 7/71	4.2% 3/72
Infections and infestations Viral infection	2.8% 2/71	0.00% 0/72
Investigations Blood pressure increased	1.4% 1/71	2.8% 2/72
Investigations Heart rate increased	4.2% 3/71	0.00% 0/72
Investigations Weight decreased	2.8% 2/71	0.00% 0/72
Metabolism and nutrition disorders Anorexia	2.8% 2/71	1.4% 1/72
Investigations Decreased appetite	22.5% 16/71	4.2% 3/72
Musculoskeletal and connective tissue disorders Back pain	4.2% 3/71	1.4% 1/72
Nervous system disorders Dizziness	2.8% 2/71	4.2% 3/72
Nervous system disorders Headache	22.5% 16/71	15.3% 11/72
Nervous system disorders Memory impairment	2.8% 2/71	0.00% 0/72
Nervous system disorders Somnolence	5.6% 4/71	2.8% 2/72
Nervous system disorders Tremor	2.8% 2/71	0.00% 0/72
Psychiatric disorders Abnormal dreams	2.8% 2/71	1.4% 1/72
Psychiatric disorders Agitation	2.8% 2/71	1.4% 1/72
Psychiatric disorders Anxiety	8.5% 6/71	5.6% 4/72
Psychiatric disorders Insomnia	14.1% 10/71	2.8% 2/72
Psychiatric disorders Nervousness	2.8% 2/71	0.00% 0/72
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/71	2.8% 2/72
Skin and subcutaneous tissue disorders Hyperhidrosis	5.6% 4/71	0.00% 0/72
Skin and subcutaneous tissue disorders Rash	4.2% 3/71	1.4% 1/72
Skin and subcutaneous tissue disorders Uticaria	2.8% 2/71	0.00% 0/72

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

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