Trial Outcomes & Findings for Armodafinil for Patients Starting Hepatitis C Virus Treatment (NCT NCT01470651)

Last Updated: 2017-02-10

Results Overview

The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

HCV medication adherence reported at 12 weeks

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Armodafinil Active medication Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks	Sugar Pill Inactive pill, matched to look like active medication Placebo Comparator: Inactive pill, matched to look like active medication
Overall Study STARTED	13	13
Overall Study COMPLETED	6	10
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Armodafinil for Patients Starting Hepatitis C Virus Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil n=13 Participants Active medication Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks	Sugar Pill n=13 Participants Inactive pill, matched to look like active medication Placebo Comparator: Inactive pill, matched to look like active medication	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	53.77 years n=5 Participants	57.23 years n=7 Participants	55.5 years n=5 Participants
Gender Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Gender Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: HCV medication adherence reported at 12 weeks

Population: Not all patients were given all medications, subjects are not factored in if they were not told to take a given drug.

Outcome measures

Outcome measures
Measure	Armodafinil n=6 Participants Active medication Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks	Sugar Pill n=10 Participants Inactive pill, matched to look like active medication Placebo Comparator: Inactive pill, matched to look like active medication
Adherence to Medications Form ribavirin	0 Percentage of doses missed Standard Error 0	3.24 Percentage of doses missed Standard Error 1.87
Adherence to Medications Form pegylated interferon	0 Percentage of doses missed Standard Error 0	1.74 Percentage of doses missed Standard Error 1.16
Adherence to Medications Form Incivek (or Victrelis)	4.95 Percentage of doses missed Standard Error 3.06	2.88 Percentage of doses missed Standard Error 1.14
Adherence to Medications Form Armodafinil or Placebo	14.00 Percentage of doses missed Standard Error 9.34	8.02 Percentage of doses missed Standard Error 4.23

SECONDARY outcome

Timeframe: Biweekly for the first month, monthly thereafter

Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, family or social life"). Response format is a 7-point Likert scale of agreement with a 1-week time frame. Total score is the sum of item scores and ranges from 9 to 63 points, with higher scores indicating greater fatigue. A score greater than 40 is considered to be a clinically significant level of fatigue. Scores on the scale correlate highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil.

Outcome measures

Outcome measures
Measure	Armodafinil n=6 Participants Active medication Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks	Sugar Pill n=10 Participants Inactive pill, matched to look like active medication Placebo Comparator: Inactive pill, matched to look like active medication
Fatigue Severity Scale (FSS) Baseline	23.29 FSS score (out of 63) Standard Deviation 17.17	26.90 FSS score (out of 63) Standard Deviation 15.34
Fatigue Severity Scale (FSS) Week 2	30.71 FSS score (out of 63) Standard Deviation 16.16	36.60 FSS score (out of 63) Standard Deviation 17.37
Fatigue Severity Scale (FSS) Week 4	37.14 FSS score (out of 63) Standard Deviation 17.58	38.90 FSS score (out of 63) Standard Deviation 15.26
Fatigue Severity Scale (FSS) Week 8	32.00 FSS score (out of 63) Standard Deviation 20.93	40.00 FSS score (out of 63) Standard Deviation 18.06
Fatigue Severity Scale (FSS) Week 12	31.71 FSS score (out of 63) Standard Deviation 20.15	38.40 FSS score (out of 63) Standard Deviation 16.290

Adverse Events

Armodafinil

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Judith Rabkin

New York State Psychiatric Institute-Research Foundation for Mental Hygene

Phone: 646-774-8075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Armodafinil n=13 participants at risk Active medication Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks	Sugar Pill n=13 participants at risk Inactive pill, matched to look like active medication Placebo Comparator: Inactive pill, matched to look like active medication
Psychiatric disorders Nervousness	33.3% 4/12 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	23.1% 3/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Psychiatric disorders Insomnia	25.0% 3/12 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	46.2% 6/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders Shortness of Breath	38.5% 5/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	69.2% 9/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders Appetite or weight change	61.5% 8/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	76.9% 10/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders Taste Change	38.5% 5/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	76.9% 10/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders Dry Mouth	61.5% 8/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	61.5% 8/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Gastrointestinal disorders Diarrhea	38.5% 5/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	46.2% 6/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Musculoskeletal and connective tissue disorders Muscle Pain	23.1% 3/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	38.5% 5/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Immune system disorders Fever	38.5% 5/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	76.9% 10/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Gastrointestinal disorders Rectal Pain	23.1% 3/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	61.5% 8/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders Headaches	69.2% 9/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	76.9% 10/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Psychiatric disorders Irritability	53.8% 7/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	76.9% 10/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Gastrointestinal disorders Nausea	53.8% 7/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	53.8% 7/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Psychiatric disorders Difficulty in Concentration	46.2% 6/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	46.2% 6/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Skin and subcutaneous tissue disorders Rash	53.8% 7/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	84.6% 11/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders Dizzyness	15.4% 2/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	23.1% 3/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders Tingling Feeling	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Vascular disorders Lightheadedness	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Gastrointestinal disorders Constipation	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	15.4% 2/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Gastrointestinal disorders Stomach pain	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Nervous system disorders feeling cold	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
General disorders Sore Throat	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Musculoskeletal and connective tissue disorders Plantar Fascitis	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Cardiac disorders Chest Pain	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Immune system disorders Allergy Symptoms	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Reproductive system and breast disorders Testicular Pain	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Psychiatric disorders Emotional instability	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Eye disorders Swollen Eyes	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Gastrointestinal disorders Altered Sense of Smell	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Musculoskeletal and connective tissue disorders Weakness	7.7% 1/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.	0.00% 0/13 • Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week. Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.