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Trial record 27 of 112 for:    Chronic Fatigue Syndrome

Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome

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ClinicalTrials.gov Identifier: NCT01071044
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : June 26, 2014
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Joel L. Young, M.D., Rochester Center for Behavioral Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Fatigue Syndrome
Cognitive Impairments
Interventions Drug: Lisdexamfetamine Dimesylate
Drug: Placebo "30, 50 or 70 mg"
Enrollment 26
Recruitment Details Study site began recruiting for the trial in Oct 2009 and the last subject completed the final visit on 3/7/11. Recruitment was done from within the Rochester Center (a private mental health practice), as well as some local advertising and community outreach.
Pre-assignment Details  
Arm/Group Title Lisdexamfetamine Dimesylate Sugar Pill
Hide Arm/Group Description

Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.

Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo).

Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
Period Title: Overall Study
Started 15 11
Completed 13 11
Not Completed 2 0
Arm/Group Title Lisdexamfetamine Dimesylate Sugar Pill Total
Hide Arm/Group Description

Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.

Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo).

Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator. Total of all reporting groups
Overall Number of Baseline Participants 15 11 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
11
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 26 participants
Female
15
 100.0%
10
  90.9%
25
  96.2%
Male
0
   0.0%
1
   9.1%
1
   3.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 11 participants 26 participants
15 11 26
1.Primary Outcome
Title BRIEF-A
Hide Description The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.
Time Frame Every 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
Placebo "30, 50 or 70 mg"
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
21.38  (15.85) 3.36  (7.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Group, Control Group
Comments These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .005
Comments [Not Specified]
Method ANOVA
Comments These data were initially analyzed with a one-way ANOVA.
2.Secondary Outcome
Title Fatigue Severity Scale (FSS)
Hide Description The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.
Time Frame Every 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
Placebo "30, 50 or 70 mg"
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
20.92  (14.71) 5.00  (11.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Group, Control Group
Comments These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Hamiliton Anxiety Inventory
Hide Description The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.
Time Frame Every 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
Placebo "30, 50 or 70 mg"
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
11.31  (9.74) 6.18  (8.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Group, Control Group
Comments These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Short Form McGill Pain Questionnaire
Hide Description The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.
Time Frame Every 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in analysis.
Arm/Group Title Lisdexamfetamine Dimesylate Control Group
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 30, 50, 70 mg
Placebo "30, 50, or 70mg"
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
10.38  (8.84) 2.45  (9.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate, Control Group
Comments These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Fibromyalgia Impact Questionnaire (FIQ)
Hide Description

The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.

Below, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients.

Time Frame Every 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
Placebo "30, 50 or 70 mg"
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
20.90  (25.54) 8.83  (18.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Group, Control Group
Comments These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.219
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)
Hide Description The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.
Time Frame Every 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate, 30, 50 or 70 mg
Placebo "30, 50 or 70 mg"
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
18.17  (11.95) 8.73  (7.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Group, Control Group
Comments These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Clinical Global Impression (Severity)
Hide Description The Clinical Global Impression (Severity) is a one-item clinician-rated measure. The item is a likert scale on which the clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.
Time Frame Every visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 30, 50 or 70 mg
Placebo "30, 50 or 70 mg"
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.92  (1.50) .64  (.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Group, Control Group
Comments These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Each subject had a period of 10 weeks at which they could report any adverse events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description Lisdexamfetamine Dimesylate 30, 50, or 70 mg Placebo "30, 50 or 70 mg"
All-Cause Mortality
Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events .04%
Treatment Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/15 (53.33%)      7/11 (63.64%)    
Ear and labyrinth disorders     
Sinus Infection *  0/15 (0.00%)  0 4/11 (36.36%)  4
Tinnitus *  1/15 (6.67%)  1 0/11 (0.00%)  0
Gastrointestinal disorders     
Decreased Appetite *  1/15 (6.67%)  1 0/11 (0.00%)  0
Nausea *  1/15 (6.67%)  1 0/11 (0.00%)  0
Metabolism and nutrition disorders     
Weight Loss *  1/15 (6.67%)  1 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle Aches *  1/15 (6.67%)  1 1/11 (9.09%)  1
Nervous system disorders     
Facial Tics *  1/15 (6.67%)  1 0/11 (0.00%)  0
Headaches *  4/15 (26.67%)  4 2/11 (18.18%)  2
Psychiatric disorders     
Agitation *  0/15 (0.00%)  0 1/11 (9.09%)  1
Anxiety *  1/15 (6.67%)  1 0/11 (0.00%)  0
Insomnia *  2/15 (13.33%)  2 0/11 (0.00%)  0
Renal and urinary disorders     
Urinary Tract Infection *  1/15 (6.67%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchitis *  0/15 (0.00%)  0 1/11 (9.09%)  1
Dry Mouth *  2/15 (13.33%)  2 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Relatively small sample size, imbalance of participants in active vs. placebo group due to pre-randomization, heterogenous sample (only one male participant in the study, who was in the control group and not the treatment group).
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
Layout table for Results Point of Contact information
Name/Title: Joel L. Young, MD
Organization: Rochester Center for Behavioral Medicine
Phone: 248-608-8800 ext 261
EMail: jyoung@rcbm.net
Layout table for additonal information
Responsible Party: Joel L. Young, M.D., Rochester Center for Behavioral Medicine
ClinicalTrials.gov Identifier: NCT01071044     History of Changes
Other Study ID Numbers: RCBM11
First Submitted: February 17, 2010
First Posted: February 18, 2010
Results First Submitted: October 29, 2012
Results First Posted: June 26, 2014
Last Update Posted: April 3, 2015