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Trial record 12 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)

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: NCT02260388
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cryptogenic Sensory Polyneuropathy
Interventions Drug: Nortriptyline
Drug: Duloxetine
Drug: Pregabalin
Drug: Mexiletine
Enrollment 402
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine
Hide Arm/Group Description

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

Period Title: Overall Study
Started 134 126 73 69
Completed 132 118 70 65
Not Completed 2 8 3 4
Reason Not Completed
Lost to Follow-up             2             8             3             4
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine Total
Hide Arm/Group Description

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

Total of all reporting groups
Overall Number of Baseline Participants 134 126 73 69 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
91
  67.9%
86
  68.3%
50
  68.5%
41
  59.4%
268
  66.7%
>=65 years
43
  32.1%
40
  31.7%
23
  31.5%
28
  40.6%
134
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
60.3  (12.7) 59.9  (14.0) 59.5  (13.6) 60.7  (13.7) 60.1  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
Female
59
  44.0%
68
  54.0%
34
  46.6%
28
  40.6%
189
  47.0%
Male
75
  56.0%
58
  46.0%
39
  53.4%
41
  59.4%
213
  53.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
Hispanic or Latino
8
   6.0%
6
   4.8%
4
   5.5%
3
   4.3%
21
   5.2%
Not Hispanic or Latino
126
  94.0%
119
  94.4%
68
  93.2%
66
  95.7%
379
  94.3%
Unknown or Not Reported
0
   0.0%
1
   0.8%
1
   1.4%
0
   0.0%
2
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
6
   4.5%
4
   3.2%
4
   5.5%
3
   4.3%
17
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   7.5%
11
   8.7%
4
   5.5%
1
   1.4%
26
   6.5%
White
113
  84.3%
104
  82.5%
62
  84.9%
64
  92.8%
343
  85.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.0%
7
   5.6%
3
   4.1%
1
   1.4%
15
   3.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
134
 100.0%
126
 100.0%
73
 100.0%
69
 100.0%
402
 100.0%
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale T-Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
PROMIS Pain Interference T-Score 63.1  (7.0) 62.4  (6.8) 63.3  (5.5) 60.9  (7.9) 62.5  (6.9)
PROMIS Fatigue T-Score 59.6  (3.4) 59.7  (3.3) 59.1  (3.7) 59.7  (3.2) 59.6  (3.4)
PROMIS Sleep Disturbance T-Score 59.1  (9.8) 60.6  (8.3) 59.8  (8.7) 57.0  (11.4) 59.3  (9.5)
[1]
Measure Description:

T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD). A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population

PROMIS Pain Interference Short Form v1.0 8a: Higher scores for pain interference represents worse outcome (more pain interference) PROMIS Fatigue Short Form v1.0 8a Higher scores indicate more fatigue (worse outcome).

PROMIS Sleep Disturbance Short Form v1.0 8a Higher scores indicate more sleep disturbance (worse outcome).

SF12 Health Component Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Norm-Based Standardization Score
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
Physical Component Score 38.0  (9.3) 38.5  (9.3) 37.9  (9.1) 41.1  (10.1) 38.7  (9.4)
Mental Component Score 48.0  (10.4) 46.7  (10.1) 46.8  (11.3) 47.2  (11.1) 47.2  (10.6)
[1]
Measure Description:

SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient’s point of view.

Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.

Scores are calibrated so that 50 is the average score or norm, standard deviation = 10.

Higher scores indicate better health for both mental and physical component summary scores.

Likert Pain Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 126 participants 73 participants 69 participants 402 participants
6.9  (1.5) 6.7  (1.6) 6.4  (1.6) 6.5  (1.7) 6.7  (1.6)
[1]
Measure Description: Likert Pain Scale - Incremental Scale 0 to 10 with 10 indicating most pain.
1.Primary Outcome
Title Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit
Hide Description The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine
Hide Arm/Group Description:

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

Overall Number of Participants Analyzed 134 126 73 69
Measure Type: Count of Participants
Unit of Measure: Participants
Efficacious and Non-Quit
34
  25.4%
29
  23.0%
11
  15.1%
14
  20.3%
Non-Efficacious and Non-Quit
49
  36.6%
50
  39.7%
31
  42.5%
15
  21.7%
Quit
51
  38.1%
47
  37.3%
31
  42.5%
40
  58.0%
2.Secondary Outcome
Title SF12 Health Composite Scores
Hide Description

SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient’s point of view.

Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.

Scores are calibrated so that 50 is the average score or norm, standard deviation = 10.

Higher scores indicate better health for both mental and physical component summary scores.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine
Hide Arm/Group Description:

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

Overall Number of Participants Analyzed 83 79 42 29
Mean (Standard Deviation)
Unit of Measure: Norm-Based Standardization Score
Mental Component Score 51.0  (8.9) 50.9  (9.9) 47.2  (11.2) 51.3  (10.8)
Physical Component Score 42.8  (8.7) 42.1  (9.5) 40.0  (8.2) 43.7  (9.6)
3.Secondary Outcome
Title PROMIS Pain Interference Short Form v1.0 8a T Score
Hide Description

Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.

On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine
Hide Arm/Group Description:

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

Overall Number of Participants Analyzed 83 79 42 29
Mean (Standard Deviation)
Unit of Measure: T-Score
56.4  (8.4) 56.5  (8.3) 60.0  (7.5) 54.5  (8.8)
4.Secondary Outcome
Title PROMIS Fatigue Short Form v1.0 8a
Hide Description

Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.

On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.

Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine
Hide Arm/Group Description:

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

Overall Number of Participants Analyzed 83 79 42 29
Mean (Standard Deviation)
Unit of Measure: T-Score
53.6  (9.5) 55.4  (10.2) 56.7  (10.6) 51.6  (10.7)
5.Secondary Outcome
Title PROMIS Sleep Disturbance Short Form v1.0 8a
Hide Description

Higher scores for sleep disturbance represents worse outcome (more sleep disturbance).

T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.

On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.

Higher scores equals more of the concept being measured

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine
Hide Arm/Group Description:

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

Overall Number of Participants Analyzed 83 79 42 29
Mean (Standard Deviation)
Unit of Measure: T-Score
58.9  (2.5) 58.9  (2.6) 58.3  (2.3) 59.1  (2.0)
Time Frame 12 Weeks Post Randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nortriptyline Duloxetine Pregabalin Mexiletine
Hide Arm/Group Description

Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.

Nortriptyline

Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.

Duloxetine

Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.

Pregabalin

Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.

Mexiletine

All-Cause Mortality
Nortriptyline Duloxetine Pregabalin Mexiletine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/134 (0.00%)   0/126 (0.00%)   0/73 (0.00%)   0/69 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nortriptyline Duloxetine Pregabalin Mexiletine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/134 (0.00%)   0/126 (0.00%)   0/73 (0.00%)   0/69 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nortriptyline Duloxetine Pregabalin Mexiletine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/134 (55.97%)   59/126 (46.83%)   29/73 (39.73%)   27/69 (39.13%) 
Ear and labyrinth disorders         
Nausea *  3/134 (2.24%)  11/126 (8.73%)  1/73 (1.37%)  6/69 (8.70%) 
Gastrointestinal disorders         
Bloating/Constipation *  10/134 (7.46%)  3/126 (2.38%)  1/73 (1.37%)  2/69 (2.90%) 
General disorders         
Insomnia *  5/134 (3.73%)  12/126 (9.52%)  1/73 (1.37%)  2/69 (2.90%) 
Nervous system disorders         
Dry Mouth *  27/134 (20.15%)  3/126 (2.38%)  1/73 (1.37%)  3/69 (4.35%) 
Drowsiness/Sleepiness *  16/134 (11.94%)  7/126 (5.56%)  8/73 (10.96%)  3/69 (4.35%) 
Fatigue *  7/134 (5.22%)  8/126 (6.35%)  3/73 (4.11%)  1/69 (1.45%) 
Headache *  4/134 (2.99%)  2/126 (1.59%)  2/73 (2.74%)  1/69 (1.45%) 
Other *  3/134 (2.24%)  13/126 (10.32%)  12/73 (16.44%)  9/69 (13.04%) 
*
Indicates events were collected by non-systematic assessment
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: Dr. Richard Barohn
Organization: University of Kansas Medical Center
Phone: 9139459943
EMail: rbarohn@kumc.edu
Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02260388     History of Changes
Other Study ID Numbers: STUDY00001500
PCORI-1306-02496 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Submitted: October 6, 2014
First Posted: October 9, 2014
Results First Submitted: March 2, 2018
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018