Trial Outcomes & Findings for Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (NCT NCT00228566)
NCT ID: NCT00228566
Last Updated: 2013-07-19
Results Overview
A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
COMPLETED
PHASE3
247 participants
Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.
2013-07-19
Participant Flow
40 centers in the US. First participant enrolled: 5 October 2005. Last participant last visit: 27 July 2006
1 female participant withdrew for noncompliance after randomization but prior to receiving study drug. The number of participants then analyzed (241) by a PGI-C rating was defined to be those participants who took at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment (5 patients did not meet this requirement).
Participant milestones
| Measure |
Armodafinil 150 to 250 mg/Day
Armodafinil 150 to 250 mg once daily in the morning
|
|---|---|
|
Overall Study
STARTED
|
247
|
|
Overall Study
COMPLETED
|
176
|
|
Overall Study
NOT COMPLETED
|
71
|
Reasons for withdrawal
| Measure |
Armodafinil 150 to 250 mg/Day
Armodafinil 150 to 250 mg once daily in the morning
|
|---|---|
|
Overall Study
Adverse Event
|
31
|
|
Overall Study
Lack of Efficacy
|
14
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Miscellaneous
|
1
|
Baseline Characteristics
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Baseline characteristics by cohort
| Measure |
Armodafinil 150 to 250 mg/Day
n=247 Participants
Armodafinil 150 to 250 mg once daily in the morning
|
|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=93 Participants
|
|
Age Categorical
Between 18 and 65 years
|
243 participants
n=93 Participants
|
|
Age Categorical
>=65 years
|
3 participants
n=93 Participants
|
|
Age Continuous
|
46.6 years
STANDARD_DEVIATION 12.53 • n=93 Participants
|
|
Gender
Female
|
137 participants
n=93 Participants
|
|
Gender
Male
|
109 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
247 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
Outcome measures
| Measure |
Armodafinil 150 to 250 mg/Day
n=241 Participants
Armodafinil 150 to 250 mg once daily in the morning
|
|---|---|
|
Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings
|
241 Participants
|
Adverse Events
Armodafinil 150 to 250 mg/Day
Serious adverse events
| Measure |
Armodafinil 150 to 250 mg/Day
n=246 participants at risk
Armodafinil 150 to 250 mg once daily in the morning
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.41%
1/246
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.41%
1/246
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.41%
1/246
|
|
Infections and infestations
Pneumonia
|
0.41%
1/246
|
|
Infections and infestations
Fetal growth retardation
|
0.41%
1/246
|
|
Infections and infestations
Iliac artery occlusion
|
0.41%
1/246
|
|
Infections and infestations
Nasal abscess
|
0.41%
1/246
|
|
Infections and infestations
Cellulitis
|
0.41%
1/246
|
Other adverse events
| Measure |
Armodafinil 150 to 250 mg/Day
n=246 participants at risk
Armodafinil 150 to 250 mg once daily in the morning
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
12.2%
30/246
|
|
Gastrointestinal disorders
Dry mouth
|
8.9%
22/246
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
13/246
|
|
Infections and infestations
Nasopharyngitis
|
14.2%
35/246
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
21/246
|
|
Nervous system disorders
Headache
|
20.3%
50/246
|
|
Nervous system disorders
Dizziness
|
5.7%
14/246
|
|
Psychiatric disorders
Anxiety
|
6.5%
16/246
|
|
Psychiatric disorders
Insomnia
|
6.1%
15/246
|
Additional Information
Sponsor's Medical Director, Clinical Research
Cephalon, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60