Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy

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: NCT00294658
Recruitment Status : Completed
First Posted : February 22, 2006
Results First Posted : January 16, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Gary Cutter, PhD, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Myasthenia Gravis
Interventions Procedure: thymectomy plus prednisone
Drug: prednisone alone
Enrollment 126
Recruitment Details The first enrollment of two patients started with July 26, 2006 and the last patient was recruited on November 28, 2012. Of the 126 randomized patients, 96 were from centers outside the US and 30 were from US centers.
Pre-assignment Details After informed consent signed, 66 patients were randomized to extended transsternal thymectomy with prednisone treatment and 60 patients were assigned to take prednisone without surgery. Within the 126 subject that started, 15 dropped out before 3 year follow-up.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy had been performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen had been taken every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Period Title: Overall Study
Started 66 60
Completed 60 51
Not Completed 6 9
Reason Not Completed
Death             0             1
Lost to Follow-up             4             0
Physician Decision             1             2
Pregnancy             0             1
Withdrawal by Subject             0             4
Found to have invasive thymoma             1             0
Patient and family were not satisfied             0             1
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone Total
Hide Arm/Group Description

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Total of all reporting groups
Overall Number of Baseline Participants 66 60 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 66 participants 60 participants 126 participants
32
(18 to 63)
33
(18 to 64)
32
(18 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Female
50
  75.8%
39
  65.0%
89
  70.6%
Male
16
  24.2%
21
  35.0%
37
  29.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Asian 6 4 10
Black 7 6 13
Hispanic 17 17 34
Non-Hispanic 31 30 61
Other 5 3 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Argentina 10 11 21
United States 16 14 30
Japan 1 1 2
United Kingdom 2 2 4
Thailand 3 2 5
Canada 9 9 18
Netherlands 1 0 1
Brazil 3 2 5
Poland 1 1 2
Italy 6 4 10
Mexico 1 0 1
South Africa 4 4 8
Australia 2 2 4
Chile 5 5 10
Germany 2 3 5
Therapy at enrollment - Pyridostigimine  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Yes 60 56 116
No 5 1 6
Missing 1 3 4
Therapy at enrollment - Glucocorticoid  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Yes 49 47 96
No 16 10 26
Missing 1 3 4
Previous therapy - Intravenous immue globulin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Yes 12 13 25
No 53 44 97
Missing 1 3 4
Previous therapy - Plasma exchange  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Yes 9 7 16
No 56 50 106
Missing 1 3 4
MGFA class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
IIa 25 25 50
IIb 18 14 32
III 21 20 41
IV 2 1 3
[1]
Measure Description:

Class IIa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.

Class IIb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.

Class III. Moderate weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.

Class IV. Severe weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.

Higher class was considered worse outcome.

Duration of disease  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 66 participants 60 participants 126 participants
1.08
(0.02 to 4.41)
1.14
(0.15 to 4.38)
1.11
(0.02 to 4.41)
QMG score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 66 participants 60 participants 126 participants
11.40  (5.12) 12.35  (4.90) 11.84  (5.02)
[1]
Measure Description: Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39, with higher scores indicating more severe disease.
Prednisone use at baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Yes 49 47 96
No 16 10 26
Missing 1 3 4
Prednisone Dosage at baseline (mg)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg
Number Analyzed 66 participants 60 participants 126 participants
43.43  (28.92) 42.49  (23.52) 42.97  (26.28)
[1]
Measure Description: Prednisone dosage unit as mg, patient has been taken prednisone every other day
1.Primary Outcome
Title Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years
Hide Description Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.15  (4.09) 8.99  (4.93)
2.Primary Outcome
Title Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years
Hide Description Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.
Time Frame baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 61 56
Mean (Standard Deviation)
Unit of Measure: mg
32  (23) 54  (29)
3.Secondary Outcome
Title Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment
Hide Description Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants in Thymectomy plus prednisone and 5 in Prednisone alone group did not provide information to enable the calculation of Time-weighted average Quantitative Myasthenia Gravis Score by prednisone use at enrollment over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 62 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Not prednisone naïve Number Analyzed 47 participants 46 participants
6.30  (3.89) 9.10  (5.06)
Prednisone naïve Number Analyzed 15 participants 9 participants
5.66  (4.79) 8.84  (4.60)
4.Secondary Outcome
Title Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex
Hide Description Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
Female Number Analyzed 46 participants 38 participants
6.47  (4.13) 9.73  (5.16)
Male Number Analyzed 16 participants 18 participants
5.23  (3.95) 7.45  (4.11)
5.Secondary Outcome
Title Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset
Hide Description Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants in each group did not provide the information to enable calculation of the time-weighted average Quantitative Myasthenia Gravis Weakness Score over 3 years. Another 2 participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the age at disease onset information.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 60 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
Age (years) at Disease Onset < 40 Number Analyzed 42 participants 34 participants
6.50  (4.41) 9.60  (5.32)
Age (years) at Disease Onset ≥ 40 Number Analyzed 18 participants 18 participants
5.33  (2.79) 7.85  (3.50)
6.Secondary Outcome
Title Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment
Hide Description Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 1 in Prednisone alone group did not provide prednisone use at enrollment information.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 61 55
Mean (Standard Deviation)
Unit of Measure: mg
Not prednisone naïve Number Analyzed 46 participants 46 participants
35  (25) 56  (31)
Prednisone naïve Number Analyzed 15 participants 9 participants
25  (17) 45  (22)
7.Secondary Outcome
Title Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex
Hide Description Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 61 56
Mean (Standard Deviation)
Unit of Measure: mg
Female Number Analyzed 45 participants 37 participants
33  (25) 54  (27)
Male Number Analyzed 16 participants 19 participants
31  (18) 55  (34)
8.Secondary Outcome
Title Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset
Hide Description Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 2 in Thymectomy plus prednisone group and 4 in Prednisone alone group did not provide age at disease onset information.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 59 52
Mean (Standard Deviation)
Unit of Measure: mg
Age (Years) at Disease Onset < 40 Number Analyzed 41 participants 33 participants
35  (25) 55  (30)
Age (Years) at Disease Onset ≥ 40 Number Analyzed 18 participants 19 participants
27  (18) 49  (29)
9.Secondary Outcome
Title Number of Serious Adverse Events
Hide Description Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: events
48 93
10.Secondary Outcome
Title Number of Patients With at Least One Serious Adverse Events
Hide Description Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 66 60
Measure Type: Number
Unit of Measure: participants
25 33
11.Secondary Outcome
Title Classification of Serious Adverse Events
Hide Description [Not Specified]
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One participant might had experienced more than one serious adverse event.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: participants
Life-threatening 1 7
Disability or incapacity 8 2
Medical or surgical intervention 9 5
Death 0 1
Complication due to thytmectomy 1 0
Hospitalization 15 31
12.Secondary Outcome
Title Hospitalization for Exacerbation of Myasthenia Gravis
Hide Description [Not Specified]
Time Frame baseline to 2 years and baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who had hospitalized over 2 and 3 years
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 15 31
Measure Type: Number
Unit of Measure: participants
Months 0-24 6 17
Months 0-36 6 22
13.Secondary Outcome
Title Cumulative Number of Hospital Days
Hide Description Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 15 31
Mean (Standard Deviation)
Unit of Measure: days
8.4  (8.6) 19.2  (24.5)
14.Secondary Outcome
Title Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term
Hide Description Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 15 31
Measure Type: Number
Unit of Measure: events
Gastrointestinal disorder 2 2
Hepatobiliary disorder 0 1
Infection or infestation 4 7
Injury, poisoning, or procedure complication 2 0
Metabolism or nutrition disorder 1 0
Nervous system disorder 8 22
Respiratory, thoracic, or mediastinal disorder 1 2
Surgical or medical procedure 0 7
Vascular disorder 0 1
15.Secondary Outcome
Title Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)
Hide Description Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period.
Time Frame baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants in each group did not provide the information to enable calculation of the time-weighted average prescribed alternate-day prednisone dose (mg) over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: mg
34.3  (22.7) 55.6  (29.4)
16.Secondary Outcome
Title Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)
Hide Description For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.
Time Frame baseline, month 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 61 56
Mean (Standard Deviation)
Unit of Measure: mg
34.4  (28.2) 64.4  (40.8)
17.Secondary Outcome
Title Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)
Hide Description For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.
Time Frame baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 61 56
Mean (Standard Deviation)
Unit of Measure: mg
33.3  (27.2) 57.9  (36.9)
18.Secondary Outcome
Title Time-Weighted Average MG Activity of Daily Living (MG-ADL)
Hide Description MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.
Time Frame baseline, month 4, 6 and every 3 months through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Five participants in each group did not provide the information to enable calculation of the time-weighted average MG activity of daily life over 3 years.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 61 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.24  (2.09) 3.41  (2.58)
19.Secondary Outcome
Title Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36
Hide Description MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life.
Time Frame Month 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were in and out at month 12, 24 and 36 visit.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 66 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 12 Number Analyzed 61 participants 54 participants
1.92  (2.73) 3.33  (3.40)
Month 24 Number Analyzed 59 participants 53 participants
2.02  (2.78) 3.11  (2.93)
Month 36 Number Analyzed 59 participants 51 participants
2.14  (2.92) 2.69  (2.80)
20.Secondary Outcome
Title Azathioprine Use
Hide Description [Not Specified]
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 65 58
Measure Type: Number
Unit of Measure: participants
11 28
21.Secondary Outcome
Title Plasma Exchange Use
Hide Description [Not Specified]
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 65 58
Measure Type: Number
Unit of Measure: participants
10 9
22.Secondary Outcome
Title Intravenous Immunoglobulin Use
Hide Description [Not Specified]
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 65 58
Measure Type: Number
Unit of Measure: participants
11 23
23.Secondary Outcome
Title Minimal Manifestation (MM) Status at Month 12, 24 and 36
Hide Description Number of participants who were in minimal manifestation status at month 12, 24 and 36.
Time Frame Month 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Number analyzed: Thymectomy plus prednisone: n=61 (Month 12), 59 (Month 24) , and 58 (Month 36); Prednisone alone n=54 (Month 12), 53 (Month 24), and 51 (Month 36)
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 66 60
Measure Type: Number
Unit of Measure: participants
Month 12 Number Analyzed 61 participants 54 participants
41 20
Month 24 Number Analyzed 59 participants 53 participants
39 20
Month 36 Number Analyzed 58 participants 51 participants
39 24
24.Secondary Outcome
Title Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
Hide Description Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)
Time Frame baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 6 17
Mean (Standard Deviation)
Unit of Measure: days
5.5  (2.9) 26.4  (28.9)
25.Secondary Outcome
Title Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
Hide Description Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 6 22
Mean (Standard Deviation)
Unit of Measure: days
8.7  (7.7) 22.5  (27.1)
26.Secondary Outcome
Title Short Form-36 Standardized Physical Component
Hide Description Range from 0 to 100, the higher the physical component value, the better the mental health.
Time Frame Month 0, Month 12, Month 24 and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were in and out by visit.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 66 60
Median (Full Range)
Unit of Measure: units on a scale
Month 0 Number Analyzed 65 participants 58 participants
41.4
(18.2 to 60.0)
37.9
(13.5 to 64.3)
Month 12 Number Analyzed 61 participants 54 participants
48.4
(11.5 to 64.4)
44.4
(21.2 to 58.8)
Month 24 Number Analyzed 59 participants 53 participants
50.3
(11.2 to 60.5)
43.0
(25.3 to 59.6)
Month 36 Number Analyzed 58 participants 50 participants
48.2
(9.8 to 61.8)
44.2
(20.4 to 58.9)
27.Secondary Outcome
Title Short Form-36 Standardized Mental Component
Hide Description Range from 0 to 100, the higher the mental component value, the better the mental health.
Time Frame Month 0, Month 12, Month 24 and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were in and out by visit.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 66 60
Median (Full Range)
Unit of Measure: units on a scale
Month 0 Number Analyzed 65 participants 58 participants
49.1
(14.6 to 65.3)
46.2
(22.4 to 70.7)
Month 12 Number Analyzed 61 participants 54 participants
39.1
(17.6 to 66.7)
41.7
(7.6 to 64.4)
Month 24 Number Analyzed 59 participants 53 participants
49.9
(14.4 to 62.3)
46.7
(21.3 to 69.1)
Month 36 Number Analyzed 58 participants 50 participants
51.7
(29.9 to 65.1)
48.2
(24.1 to 69.2)
28.Secondary Outcome
Title Treatment Associated Complications (TAC)
Hide Description Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.
Time Frame Month 0, 1, 2, 3, 4 then every 3 months through Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were in and out by each visit.
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 66 60
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 Number Analyzed 65 participants 58 participants
22
  33.8%
17
  29.3%
Month 1 Number Analyzed 58 participants 56 participants
15
  25.9%
15
  26.8%
Month 2 Number Analyzed 61 participants 55 participants
22
  36.1%
20
  36.4%
Month 3 Number Analyzed 61 participants 55 participants
21
  34.4%
16
  29.1%
Month 4 Number Analyzed 62 participants 56 participants
23
  37.1%
23
  41.1%
Month 6 Number Analyzed 61 participants 55 participants
21
  34.4%
22
  40.0%
Month 9 Number Analyzed 61 participants 54 participants
37
  60.7%
26
  48.1%
Month 12 Number Analyzed 61 participants 54 participants
35
  57.4%
28
  51.9%
Month 15 Number Analyzed 60 participants 53 participants
29
  48.3%
24
  45.3%
Month 18 Number Analyzed 59 participants 53 participants
28
  47.5%
24
  45.3%
Month 21 Number Analyzed 60 participants 52 participants
22
  36.7%
20
  38.5%
Mpnth 24 Number Analyzed 59 participants 53 participants
28
  47.5%
23
  43.4%
Mpnth 27 Number Analyzed 61 participants 53 participants
25
  41.0%
17
  32.1%
Month 30 Number Analyzed 58 participants 53 participants
23
  39.7%
19
  35.8%
Month 33 Number Analyzed 61 participants 52 participants
24
  39.3%
23
  44.2%
Month 36 Number Analyzed 59 participants 51 participants
23
  39.0%
23
  45.1%
29.Secondary Outcome
Title Treatment Associated Symptoms (TAS)
Hide Description Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.
Time Frame Month 0, 1, 2, 3, 4 then every 3 months through Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were in and out by visit
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description:

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Overall Number of Participants Analyzed 66 60
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 Number Analyzed 65 participants 57 participants
63
  96.9%
53
  93.0%
Month 1 Number Analyzed 58 participants 56 participants
55
  94.8%
52
  92.9%
Month 2 Number Analyzed 61 participants 55 participants
61
 100.0%
53
  96.4%
Month 3 Number Analyzed 61 participants 55 participants
60
  98.4%
54
  98.2%
Month 4 Number Analyzed 62 participants 56 participants
59
  95.2%
54
  96.4%
Month 6 Number Analyzed 61 participants 55 participants
60
  98.4%
53
  96.4%
Month 9 Number Analyzed 61 participants 54 participants
59
  96.7%
50
  92.6%
Month 12 Number Analyzed 61 participants 54 participants
56
  91.8%
52
  96.3%
Month 15 Number Analyzed 60 participants 53 participants
56
  93.3%
51
  96.2%
Month 18 Number Analyzed 59 participants 53 participants
52
  88.1%
51
  96.2%
Month 21 Number Analyzed 60 participants 52 participants
52
  86.7%
50
  96.2%
Mpnth 24 Number Analyzed 59 participants 53 participants
52
  88.1%
51
  96.2%
Mpnth 27 Number Analyzed 61 participants 53 participants
50
  82.0%
50
  94.3%
Month 30 Number Analyzed 58 participants 53 participants
49
  84.5%
50
  94.3%
Month 33 Number Analyzed 61 participants 51 participants
51
  83.6%
48
  94.1%
Month 36 Number Analyzed 60 participants 51 participants
49
  81.7%
47
  92.2%
Time Frame Adverse events were reported from baseline to 3 years
Adverse Event Reporting Description There were two groups: 60 patients who received prednisone only and 66 patients had thymectomy plus prednisone
 
Arm/Group Title Thymectomy Plus Prednisone Prednisone Alone
Hide Arm/Group Description

Procedure: Extended Transsternal Thymectomy plus prednisone treatment

thymectomy: The thymectomy will be performed as soon as possible after randomization.

Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

All-Cause Mortality
Thymectomy Plus Prednisone Prednisone Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Thymectomy Plus Prednisone Prednisone Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/66 (37.88%)      33/60 (55.00%)    
Blood and lymphatic system disorders     
Pancytopenia * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Ear and labyrinth disorders     
Deafness * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Gastrointestinal disorders     
Abdominal hernia * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Dyspepsia * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Umbilical hernia * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Vomiting * 1  1/66 (1.52%)  1 1/60 (1.67%)  1
General disorders     
Cardiac death * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Hepatobiliary disorders     
Bile duct stone * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Cholelithiasis * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Infections and infestations     
Appendicitis * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Bronchitis bacterial * 1  1/66 (1.52%)  1 3/60 (5.00%)  4
Device related sepsis * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Diverticulitis * 1  0/66 (0.00%)  0 1/60 (1.67%)  4
Gastroenteritis * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Incision site cellulitis * 1  2/66 (3.03%)  2 0/60 (0.00%)  0
Pneumonia bacterial * 1  1/66 (1.52%)  2 3/60 (5.00%)  3
Pyelonephritis * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Pyelonephritis acute * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Septic shock * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Upper respiratory tract infection bacterial * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Urinary tract infection * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Viral upper respiratory tract infection * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Injury, poisoning and procedural complications     
Fibula fracture * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Forearm fracture * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Incisional hernia * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Meniscus lesion * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Muscle injury * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Rib fracture * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Tibia fracture * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control * 1  1/66 (1.52%)  2 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteonecrosis * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Osteopenia * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Osteoporotic fracture * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Nervous system disorders     
Myasthenia gravis * 1  6/66 (9.09%)  7 22/60 (36.67%)  43
Myasthenia gravis crisis * 1  4/66 (6.06%)  6 10/60 (16.67%)  13
Phrenic nerve paralysis * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Pregnancy * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Renal and urinary disorders     
Renal failure * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Renal impairment * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Diaphragm muscle weakness * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Dyspnoea * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Hypoxia * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Pleural effusion * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Pleurisy * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Pneumothorax * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Pulmonary embolism * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Sleep apnoea syndrome * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Surgical and medical procedures     
Eye operation * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Supportive care * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Thoracotomy * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
Thymectomy * 1  0/66 (0.00%)  0 7/60 (11.67%)  7
Thyroidectomy * 1  1/66 (1.52%)  1 0/60 (0.00%)  0
Vascular disorders     
Hypertensive crisis * 1  0/66 (0.00%)  0 1/60 (1.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Thymectomy Plus Prednisone Prednisone Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/66 (83.33%)      48/60 (80.00%)    
Eye disorders     
Cataract * 1  4/66 (6.06%)  14 7/60 (11.67%)  20
Glaucoma * 1  5/66 (7.58%)  22 1/60 (1.67%)  1
Infections and infestations     
Herpes zoster * 1  5/66 (7.58%)  6 4/60 (6.67%)  8
Injury, poisoning and procedural complications     
Tendon rupture * 1  2/66 (3.03%)  2 3/60 (5.00%)  3
Investigations     
Liver function test abnormal * 1  2/66 (3.03%)  2 3/60 (5.00%)  3
Metabolism and nutrition disorders     
Abnormal weight gain * 1  32/66 (48.48%)  184 31/60 (51.67%)  141
Diabetes mellitus * 1  6/66 (9.09%)  41 9/60 (15.00%)  44
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  15/66 (22.73%)  43 4/60 (6.67%)  9
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin cancer * 1  1/66 (1.52%)  1 3/60 (5.00%)  3
Psychiatric disorders     
Mental disorder * 1  4/66 (6.06%)  4 5/60 (8.33%)  8
Sleep disorder * 1  25/66 (37.88%)  86 22/60 (36.67%)  67
Skin and subcutaneous tissue disorders     
Rash * 1  21/66 (31.82%)  58 24/60 (40.00%)  48
Scab * 1  11/66 (16.67%)  44 2/60 (3.33%)  2
Vascular disorders     
Hypertension * 1  16/66 (24.24%)  53 16/60 (26.67%)  55
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Potential weakness of this trial include the single-blinded and pill count methodology.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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. Gary Cutter, Professor
Organization: University of Alabama at Birmingham
Phone: 205-975-5048
EMail: cutter@uab.edu
Publications of Results:
Layout table for additonal information
Responsible Party: Gary Cutter, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00294658     History of Changes
Other Study ID Numbers: R01NS050733
1U01NS042685-01A2 ( U.S. NIH Grant/Contract )
CRC ( Other Identifier: NINDS )
First Submitted: February 21, 2006
First Posted: February 22, 2006
Results First Submitted: September 19, 2016
Results First Posted: January 16, 2017
Last Update Posted: May 23, 2017