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Trial record 8 of 239 for:    (armodafinil)

Armodafinil for Patients Starting Hepatitis C Virus Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01470651
Recruitment Status : Terminated (European Medicines Agency issued a drug/drug interaction: sofosbuvir/modafinil)
First Posted : November 11, 2011
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Judith G. Rabkin, PhD, Research Foundation for Mental Hygiene, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Armodafinil
Drug: Sugar Pill
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Armodafinil Sugar Pill
Hide Arm/Group Description

Active medication

Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks

Inactive pill, matched to look like active medication

Placebo Comparator: Inactive pill, matched to look like active medication

Period Title: Overall Study
Started 13 13
Completed 6 10
Not Completed 7 3
Arm/Group Title Armodafinil Sugar Pill Total
Hide Arm/Group Description

Active medication

Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks

Inactive pill, matched to look like active medication

Placebo Comparator: Inactive pill, matched to look like active medication

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  92.3%
10
  76.9%
22
  84.6%
>=65 years
1
   7.7%
3
  23.1%
4
  15.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
53.77
(28 to 65)
57.23
(36 to 70)
55.5
(28 to 70)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
3
  23.1%
3
  23.1%
6
  23.1%
Male
10
  76.9%
10
  76.9%
20
  76.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Adherence to Medications Form
Hide Description 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.
Time Frame HCV medication adherence reported at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not all patients were given all medications, subjects are not factored in if they were not told to take a given drug.
Arm/Group Title Armodafinil Sugar Pill
Hide Arm/Group Description:

Active medication

Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks

Inactive pill, matched to look like active medication

Placebo Comparator: Inactive pill, matched to look like active medication

Overall Number of Participants Analyzed 6 10
Mean (Standard Error)
Unit of Measure: Percentage of doses missed
pegylated interferon Number Analyzed 6 participants 10 participants
0  (0) 1.74  (1.16)
ribavirin Number Analyzed 6 participants 10 participants
0  (0) 3.24  (1.87)
Incivek (or Victrelis) Number Analyzed 5 participants 9 participants
4.95  (3.06) 2.88  (1.14)
Armodafinil or Placebo Number Analyzed 6 participants 10 participants
14.00  (9.34) 8.02  (4.23)
2.Secondary Outcome
Title Fatigue Severity Scale (FSS)
Hide Description 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.
Time Frame Biweekly for the first month, monthly thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Sugar Pill
Hide Arm/Group Description:

Active medication

Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks

Inactive pill, matched to look like active medication

Placebo Comparator: Inactive pill, matched to look like active medication

Overall Number of Participants Analyzed 6 10
Mean (Standard Deviation)
Unit of Measure: FSS score (out of 63)
Baseline 23.29  (17.17) 26.90  (15.34)
Week 2 30.71  (16.16) 36.60  (17.37)
Week 4 37.14  (17.58) 38.90  (15.26)
Week 8 32.00  (20.93) 40.00  (18.06)
Week 12 31.71  (20.15) 38.40  (16.290)
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Armodafinil Sugar Pill
Hide Arm/Group Description

Active medication

Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks

Inactive pill, matched to look like active medication

Placebo Comparator: Inactive pill, matched to look like active medication

All-Cause Mortality
Armodafinil Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Armodafinil Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   12/13 (92.31%)   13/13 (100.00%) 
Cardiac disorders     
Chest Pain   0/13 (0.00%)  1/13 (7.69%) 
Eye disorders     
Swollen Eyes   1/13 (7.69%)  0/13 (0.00%) 
Gastrointestinal disorders     
Diarrhea   5/13 (38.46%)  6/13 (46.15%) 
Rectal Pain   3/13 (23.08%)  8/13 (61.54%) 
Nausea   7/13 (53.85%)  7/13 (53.85%) 
Constipation   0/13 (0.00%)  2/13 (15.38%) 
Stomach pain   0/13 (0.00%)  1/13 (7.69%) 
Altered Sense of Smell   0/13 (0.00%)  1/13 (7.69%) 
General disorders     
Sore Throat   1/13 (7.69%)  0/13 (0.00%) 
Immune system disorders     
Fever   5/13 (38.46%)  10/13 (76.92%) 
Allergy Symptoms   0/13 (0.00%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders     
Muscle Pain   3/13 (23.08%)  5/13 (38.46%) 
Plantar Fascitis   1/13 (7.69%)  0/13 (0.00%) 
Weakness   1/13 (7.69%)  0/13 (0.00%) 
Nervous system disorders     
Shortness of Breath   5/13 (38.46%)  9/13 (69.23%) 
Appetite or weight change   8/13 (61.54%)  10/13 (76.92%) 
Taste Change   5/13 (38.46%)  10/13 (76.92%) 
Dry Mouth   8/13 (61.54%)  8/13 (61.54%) 
Headaches   9/13 (69.23%)  10/13 (76.92%) 
Dizzyness   2/13 (15.38%)  3/13 (23.08%) 
Tingling Feeling   1/13 (7.69%)  0/13 (0.00%) 
feeling cold   0/13 (0.00%)  1/13 (7.69%) 
Psychiatric disorders     
Nervousness   4/12 (33.33%)  3/13 (23.08%) 
Insomnia   3/12 (25.00%)  6/13 (46.15%) 
Irritability   7/13 (53.85%)  10/13 (76.92%) 
Difficulty in Concentration   6/13 (46.15%)  6/13 (46.15%) 
Emotional instability   0/13 (0.00%)  1/13 (7.69%) 
Reproductive system and breast disorders     
Testicular Pain   0/13 (0.00%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough   1/13 (7.69%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders     
Rash   7/13 (53.85%)  11/13 (84.62%) 
Vascular disorders     
Lightheadedness   0/13 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
It is difficult to attribute side effects to Armodafinil or placebo given patients were undergoing Hepatitis C Treatment throughout the trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Judith Rabkin
Organization: New York State Psychiatric Institute-Research Foundation for Mental Hygene
Phone: 646-774-8075
Responsible Party: Judith G. Rabkin, PhD, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01470651     History of Changes
Other Study ID Numbers: C10953/6285
First Submitted: October 13, 2011
First Posted: November 11, 2011
Results First Submitted: October 25, 2016
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017