Methylphenidate in Treating Patients With Fatigue Caused... | NCT00376675

ID	Type	Description	Link
NCI-2012-02701	Registry Identifier	CTRP (Clinical Trials Reporting System)
CDR0000495148	Registry Identifier	PDQ (Physician Data Query)

Name	Class
National Cancer Institute (NCI)	NIH
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	INDUSTRY

Description Module

Detailed Description

OBJECTIVES:

Primary

Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory.

Secondary

Evaluate the tolerability and adverse events associated with this drug in these patients.
Study the effect of this drug on quality of life (QOL)-related variables (vitality, sleep quality, overall QOL, QOL domains, other fatigue measures, and perceived treatment efficacy) in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (0, I, or II vs III or IV), level of fatigue at baseline (4-7 vs 8-10), concurrent biological therapy (yes vs no), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral methylphenidate daily on days 1-28.
Arm II: Patients receive oral placebo daily on days 1-28.

Patients in both arms complete questionnaires to assess their symptoms of fatigue, overall mood, quality of life, sleep quality, and adverse effects from treatment at baseline and once weekly for 4 weeks. Patients also complete a Symptom Experience Diary.

McNeil Consumer & Specialty Pharmaceuticals provided medication support for NCCTG N05C7.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Label	Type	Description	Intervention Names
Arm I	Experimental	Patients receive oral methylphenidate hydrochloride daily on days 1-28.	Drug: methylphenidate hydrochloride
Arm II	Placebo Comparator	Patients receive oral placebo daily on days 1-28.	Other: placebo

Name	Type	Description	Arm Group Labels	Other Names
methylphenidate hydrochloride	Drug	Given orally	Arm I
placebo

Measure	Description	Time Frame
Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4	The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following: For those completed 4 weeks item: AUC/4; For those completed up to week 3 item: (AUC * 4) / 3; For those completed up to week 2 item: AUC * 2; For those completed up to week 1 item: AUC * 4; The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis.	Baseline to week 4

Measure	Description	Time Frame
Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4	The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 years of age
Men or women with a history of cancer-related fatigue as defined by a score ≥ 4 on a fatigue numerical analogue scale (0 - 10)
Fatigue for ≥ 1 month prior to registration
ECOG Performance Score (PS) 0, 1, or 2
Life expectancy ≥ 6 months
Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma
Laboratory values obtained ≤ 30 days prior to registration:
- Hgb ≥ 10 g/dL
Willing and able to provide informed consent
Negative pregnancy test (urine or serum) done ≤ 7 days prior to registration, for women of childbearing potential only
Ability to complete questionnaire(s) by themselves or with assistance
Biological therapy (i.e. immunotherapy, biotherapy), chemotherapy or radiation therapy will be allowed
Use of a stable dose of anti-depressants (except tricyclic anti-depressants) will be allowed
Erythropoietic agents to treat anemia, and steroids as a part of cancer treatment and for symptom management (except for fatigue) will be allowed

Exclusion Criteria:

Hypersensitivity to methylphenidate
Any prior use of methylphenidate
Concomitant (≤ 2 weeks) use of prescription stimulants (pemoline, modafinil, amphetamines); other medications, herbal products or dietary supplements for fatigue
Uncontrolled hypertension [defined as systolic blood pressure (BP) ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg on 2 separate visits ≤ 2 months prior to randomization]; or a resting heart rate > 100
Moderate or severe pain as defined by an average daily score ≥ 4 on a pain analog scale (0 - 10)
Known brain metastasis or primary CNS malignancy
Clinically significant acute or chronic progressive or unstable neurologic (dementia, delirium, or seizure disorder), hepatic, renal, cardiovascular, thyroid, or respiratory disease that would limit participation in the study per MD discretion or judgment
Psychiatric disorder such as manic depression, anxiety disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia
Major surgery < 4 weeks prior to registration. (Note: Insertion of central venous catheter is not considered major surgery.)
Using a drug contraindicated when taken concurrently with methylphenidate: coumarin anticoagulants, anticonvulsants, tricyclic antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline, and pseudoephedrine

Note: use of Compazine prescribed as an antiemetic is permitted for use while participating in this study.
Additional medical conditions where use of methylphenidate is contraindicated:

glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, history of drug or alcohol abuse or intestinal obstruction.
Pregnant women or nursing women. Women of childbearing potential who are unwilling to employ adequate contraception. This study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown.
Untreated hypothyroidism (TSH ≥ 5)

Name	Affiliation	Role
Amit Sood, MD	Mayo Clinic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Scottsdale		Scottsdale	Arizona	85259-5499	United States
Aurora Presbyterian Hospital

PubMed Identifier	Type	Citation	Retractions
20625123	Result	Moraska AR, Sood A, Dakhil SR, Sloan JA, Barton D, Atherton PJ, Suh JJ, Griffin PC, Johnson DB, Ali A, Silberstein PT, Duane SF, Loprinzi CL. Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial. J Clin Oncol. 2010 Aug 10;28(23):3673-9. doi: 10.1200/JCO.2010.28.1444. Epub 2010 Jul 12.

ID	Title	Description
FG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
FG001	Placebo	Patients receive oral placebo daily on days 1-28.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00059.2± 11.23 BG00160.6± 13.82 BG00259.9± 12.58

Age, Customized

Number

participants

Title

Denominators

Categories

<50 years

Title	Measurements
	BG00014 BG00114 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00044 BG00140 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00069 BG00170 BG002

Current chemotherapy

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00044 BG00145 BG002

Curative intent treatment

Number

participants

Title

Denominators

Categories

Missing

Title	Measurements
	BG0000 BG0012 BG002

Concurrent radiation

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0009 BG0017 BG002

Concurrent biological therapy

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00017 BG00117 BG002

Fatigue scale

Fatigue was measured using a scale of 0 to 10, with 0 (No fatigue) and 10 (Fatigue as bad as you can imagine).

Number

participants

Title

Denominators

Categories

4-7

Title	Measurements
	BG00047 BG00148 BG002

Stage

Stage 0: Carcinoma in situ; Stage I, II and III: Higher numbers indicate more extensive disease: larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor; Stage IV: The cancer has spread to distant tissues or organs

Number

participants

Title

Denominators

Categories

0/I/II

Title	Measurements
	BG00022 BG001

Type of cancer

Number

participants

Title

Denominators

Categories

Breast

Title	Measurements
	BG00026 BG00120 BG002

Average fatigue over the last week

Fatigue was measured in a scale of 0 to 100 with 0 (poor quality of life or bad symptoms) and 100 (best quality of life or no symptoms).

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00033.6± 15.43 BG001

Average pain over the last 24 hours

Pain was measured in a scale of 0 to 100 with 0 (poor quality of life or bad symptoms) and 100 (best quality of life or no symptoms).

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00087± 13.88 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4

The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following:

For those completed 4 weeks item: AUC/4;
For those completed up to week 3 item: (AUC * 4) / 3;
For those completed up to week 2 item: AUC * 2;
For those completed up to week 1 item: AUC * 4;

The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis.

All participants meeting the eligibility criteria who have signed a consent form, started treatment, and provided a baseline and one post-baseline usual fatigue score were evaluable for this analysis.

Posted

Mean

Standard Deviation

units on a scale

Baseline to week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units	Counts
Participants	OG00062 OG00163

Title

Denominators

Categories

Title	Measurements
	OG00050.33± 20.32 OG00147.15± 17.00

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon rank sum test		0.317													No	Superiority or Other

Secondary

Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4

The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4.

All participants who have provided a baseline and week 4 SED scores were evaluable for this analysis.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units	Counts
Participants	OG000

Secondary

AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4

Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.

All participants who have provided a baseline and one post-baseline PSQI score were evaluable for this analysis.

Posted

Mean

Standard Deviation

units on a scale * weeks

Baseline to Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units	Counts
Participants	OG000

Secondary

AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4

The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.

All participants who have provided a baseline and one post-baseline Vitality subscale score were evaluable for this analysis.

Posted

Mean

Standard Deviation

units on a scale * weeks

Baseline to Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units	Counts
Participants	OG000

Secondary

AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4

Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.

All participants who have provided a baseline and one post-baseline LASA score were evaluable for this analysis.

Posted

Mean

Standard Deviation

units on a scale * weeks

Baseline to Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units	Counts
Participants	OG000

Secondary

AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4

Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.

All participants who have provided a baseline and one post-baseline BFI score were evaluable for this analysis.

Posted

Mean

Standard Deviation

units on a scale * weeks

Baseline to Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units	Counts
Participants	OG000

Secondary

Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue

Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of "a little better" via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms).

All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of "a little better" via SGIC scores.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units

Secondary

Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue

All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of "a little better" via SGIC scores.

Posted

Mean

Standard Deviation

Units on scale

Baseline and Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units

Secondary

Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue

All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of "a little better" via SGIC scores.

Posted

Mean

Standard Deviation

Units on scale

Baseline and Week 4

ID	Title	Description
OG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
OG001	Placebo	Patients receive oral placebo daily on days 1-28.

Units

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hemoglobin decreased	Blood and lymphatic system disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Palpitations	Cardiac disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Abdominal pain	Gastrointestinal disorders	CTCAEV3.0	Systematic Assessment	EG00033 events16 affected68 at risk EG00153 events21 affected69 at risk
Constipation	Gastrointestinal disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0012 events1 affected69 at risk
Diarrhea	Gastrointestinal disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Flatulence	Gastrointestinal disorders	CTCAEV3.0	Systematic Assessment	EG0002 events1 affected68 at risk EG0010 events0 affected69 at risk
Nausea	Gastrointestinal disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Vomiting	Gastrointestinal disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0012 events1 affected69 at risk
Disease progression	General disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Fatigue	General disorders	CTCAEV3.0	Systematic Assessment	EG0005 events2 affected68 at risk EG0019 events4 affected69 at risk
Fever	General disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Infection	Infections and infestations	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0013 events1 affected69 at risk
Bruising	Injury, poisoning and procedural complications	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Fracture	Injury, poisoning and procedural complications	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Leukocyte count decreased	Investigations	CTCAEV3.0	Systematic Assessment	EG0002 events2 affected68 at risk EG0010 events0 affected69 at risk
Lymphocyte count decreased	Investigations	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Neutrophil count decreased	Investigations	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Platelet count decreased	Investigations	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Anorexia	Metabolism and nutrition disorders	CTCAEV3.0	Systematic Assessment	EG0002 events2 affected68 at risk EG0011 events1 affected69 at risk
Blood glucose increased	Metabolism and nutrition disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Serum albumin decreased	Metabolism and nutrition disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Serum potassium decreased	Metabolism and nutrition disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Serum sodium decreased	Metabolism and nutrition disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0012 events2 affected69 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0014 events2 affected69 at risk
Dizziness	Nervous system disorders	CTCAEV3.0	Systematic Assessment	EG00040 events18 affected68 at risk EG00158 events25 affected69 at risk
Headache	Nervous system disorders	CTCAEV3.0	Systematic Assessment	EG00055 events28 affected68 at risk EG00139 events21 affected69 at risk
Intracranial hemorrhage	Nervous system disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Syncope	Nervous system disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0011 events1 affected69 at risk
Tremor	Nervous system disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0011 events1 affected69 at risk
Anxiety	Psychiatric disorders	CTCAEV3.0	Systematic Assessment	EG00044 events24 affected68 at risk EG00166 events24 affected69 at risk
Confusion	Psychiatric disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Depression	Psychiatric disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0011 events1 affected69 at risk
Insomnia	Psychiatric disorders	CTCAEV3.0	Systematic Assessment	EG00080 events37 affected68 at risk EG00180 events32 affected69 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0014 events1 affected69 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	CTCAEV3.0	Systematic Assessment	EG0001 events1 affected68 at risk EG0010 events0 affected69 at risk
Sweating	Skin and subcutaneous tissue disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk
Hypotension	Vascular disorders	CTCAEV3.0	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected69 at risk

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.
BG001	Placebo	Patients receive oral placebo daily on days 1-28.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Methylphenidate	Patients receive oral methylphenidate daily on days 1-28.			0	68	56	68
EG001	Placebo	Patients receive oral placebo daily on days 1-28.			0	69	54	69