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Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS) (IPPoMS)

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ClinicalTrials.gov Identifier: NCT00950248
Recruitment Status : Completed
First Posted : July 31, 2009
Results First Posted : March 7, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Primary Progressive Multiple Sclerosis
Interventions Drug: Idebenone
Other: placebo
Enrollment 85
Recruitment Details Between November 1, 2009 and July 23, 2015, 85 patients were assessed for eligibility and enrolled into the IPPoMS trial at National Institutes of Health, Bethesda, MD
Pre-assignment Details  
Arm/Group Title Untreated Idebenone Placebo
Hide Arm/Group Description Patients in their first year baseline prior to study drug phase

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Period Title: Year 1: Baseline
Started 85 0 0
Completed 77 0 0
Not Completed 8 0 0
Reason Not Completed
Withdrawal by Subject             6             0             0
worsening of symptoms             2             0             0
Period Title: Year 2&3 Treatment Randomization
Started 0 39 38
Completed 0 33 33
Not Completed 0 6 5
Reason Not Completed
worsening of symptoms             0             2             4
Withdrawal by Subject             0             3             0
Death             0             0             1
MRI contraindication             0             1             0
Arm/Group Title Idebenone Placebo Total
Hide Arm/Group Description

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Total of all reporting groups
Overall Number of Baseline Participants 39 38 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
37
  97.4%
76
  98.7%
>=65 years
0
   0.0%
1
   2.6%
1
   1.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
Female
17
  43.6%
20
  52.6%
37
  48.1%
Male
22
  56.4%
18
  47.4%
40
  51.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.6%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.7%
3
   7.9%
6
   7.8%
White
36
  92.3%
34
  89.5%
70
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Age at Disease onset  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants 38 participants 77 participants
43.2
(18.5 to 63.7)
42.6
(24.2 to 57.5)
42.9
(18.5 to 63.7)
Time since disease onset at baseline  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants 38 participants 77 participants
13.6
(0.2 to 38.7)
11.9
(1.6 to 30.1)
12.7
(0.2 to 38.7)
Body Mass Index  
Mean (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 39 participants 38 participants 77 participants
25.7
(16.4 to 33.9)
25.8
(19.9 to 39)
25.8
(16.4 to 39)
History of Mononucleosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
Positive
8
  20.5%
6
  15.8%
14
  18.2%
Negative
19
  48.7%
19
  50.0%
38
  49.4%
Unknown
12
  30.8%
13
  34.2%
25
  32.5%
Northern European Ancestry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
Positive
17
  43.6%
18
  47.4%
35
  45.5%
Negative
5
  12.8%
5
  13.2%
10
  13.0%
Unknown
17
  43.6%
15
  39.5%
32
  41.6%
Family History of MS  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
Positive
13
  33.3%
8
  21.1%
21
  27.3%
Negative
26
  66.7%
28
  73.7%
54
  70.1%
Unknown
0
   0.0%
2
   5.3%
2
   2.6%
History of Smoking  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
Positive
29
  74.4%
30
  78.9%
59
  76.6%
Negative
9
  23.1%
3
   7.9%
12
  15.6%
Unknown
1
   2.6%
5
  13.2%
6
   7.8%
1.Primary Outcome
Title Change in the Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE) From Baseline to Treatment Phase
Hide Description

The AUCs of the CombiWISE scores during the 2-year treatment period was analyzed using an Analysis of Covariance (ANCOVA) model with the AUC of the pre-treatment CombiWISE scores, Baseline (Month 0) CombiWISE score and Baseline age as covariates.

CombiWISE is a composite scale derived from Expanded Disability Status Scale (EDSS) , Scripps Neurological Disability Scale (SNRS), times 25 foot walk (25FW), and non-dominant hand of 9 hole peg test (9HPT) with a minimum value of 0 (no disability) and maximum value of 100 (maximum disability).

The AUC values were calculated for both the pre-treatment baseline phase (from Months -12, -6, and 0) and for the double-blind phase (from Months 0, 6, 12, 18, and 24).

Because the follow-up times varied from patient to patient, the AUC values were made comparable by scaling them by dividing the AUC value by the square of the actual duration (in years) of each of the phases.

Time Frame 1-year pre-treatment baseline vs 2-year treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcome was assessed in Intention-to-treat population of patients: all randomized patients who have at least one post-baseline (post Mo 0) efficacy assessment. 38 out of 39 patients randomized to idebenone and 35 out of 38 patients randomized to placebo fulfill this definition.
Arm/Group Title Idebenone Placebo
Hide Arm/Group Description:

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Overall Number of Participants Analyzed 38 35
Mean (Standard Deviation)
Unit of Measure: units on a scale per year
-0.13  (2.17) -1.04  (2.87)
2.Secondary Outcome
Title Change in the AUC of Individualized Rates of Enlargement of Ventricular Volume From Baseline to Treatment Phase
Hide Description

The AUCs of the Ventricular volume scores (individualized rates of enlargement of segmented volume of lateral and 3rd ventricles) during the baseline and the 2-year treatment period were assessed using an ANCOVA model with the AUC of the pre-treatment Volumetric score, Baseline (Month 0) Volumetric score, and group as covariates.

The AUC values were calculated for both the pre-treatment baseline phase (from Months -12, -6, and 0) and for the double-blind phase (from Months 0, 6, 12, 18 and 24).

Because the follow-up times varied from patient to patient, the AUC values were made comparable by scaling them by dividing the AUC value by the square of the actual duration (in years) of each of the phases.

Time Frame 1-year pre-treatment baseline vs 2-year treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcome was assessed in Intention-to-treat population. Due to technical error in MRI images processing 2 out of 38 idebenone patients were excluded from the analysis.
Arm/Group Title Idebenone Placebo
Hide Arm/Group Description:

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: ml per year
-244  (1094.9) 35.4382  (1091.1)
3.Secondary Outcome
Title Disability Progression Measured by EDSS-plus
Hide Description

Categorical time-to-event endpoints (EDSS-plus) were analyzed using Cox Proportional hazards models, with treatment group as a covariate. The EDSS-plus event was defined as disability progression on at least 1 of 3 components [EDSS, 25FW, and/or non-dominant hand 9HPT]) confirmed 6 months apart and with a ≥ 20% minimum threshold change for 25FW and non-dominant hand 9HPT).

The patients who did not have an event during the study were censored at the time of the last assessment of EDSS-plus. The number of months from the date of first dose to date of event or censoring were used as endpoint. The measure is time to disease progression and unit of this measure is months.

Time Frame 2-year treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome was assessed in the Intention-to-treat population of patients: all randomized patients who have at least one post-baseline (post Mo 0) efficacy assessment. 38 out of 39 patients randomized to idebenone and 35 out of 38 patients randomized to placebo fulfill this definition.
Arm/Group Title Idebenone Placebo
Hide Arm/Group Description:

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Overall Number of Participants Analyzed 38 35
Median (95% Confidence Interval)
Unit of Measure: months
23.1 [1] 
(12.8 to NA)
23.7 [1] 
(19.8 to NA)
[1]
the upper limit of the 95% confidence interval cannot be estimated due to insufficient number of participants with events
4.Secondary Outcome
Title Change in Slopes of 25FW Time From Baseline to Treatment Phase
Hide Description

Lower extremity disability was measured by an average of two trials of timed 25 foot walk assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.

The maximum time assigned for a trial is 180s. Patients unable to complete the 25 foot trial within this time limit are coded as "179.9"

Time Frame 1-year pre-treatment baseline vs 2-year treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
Arm/Group Title Idebenone Placebo
Hide Arm/Group Description:

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Overall Number of Participants Analyzed 33 33
Mean (Standard Error)
Unit of Measure: seconds per year
0.02451  (0.01668) -0.01015  (0.01889)
5.Secondary Outcome
Title Change in Slopes of 9HPT Time From Baseline to Treatment Phase
Hide Description Upper extremity/fine motor movements disability was measured as an average of left and right hand time, with each hand assessed as an average of two trials with upper limit of 5 (300s) per trial. Patients unable to complete the task within this time are coded as "777" The outcome was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.
Time Frame 1-year pre-treatment baseline vs 2-year treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
Arm/Group Title Idebenone Placebo
Hide Arm/Group Description:

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Overall Number of Participants Analyzed 33 33
Mean (Standard Error)
Unit of Measure: seconds per year
0.001693  (0.000843) -0.0003  (0.000955)
6.Secondary Outcome
Title Change in Slopes of SNRS From Baseline to Treatment Phase on
Hide Description SNRS scale combines various elements of a neurological exam into a single number. The scale ranges from 100 to 0, where 100 marks no disability and 0 marks maximum disability. SNRS was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.
Time Frame 1-year pre-treatment baseline vs 2-year treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
Arm/Group Title Idebenone Placebo
Hide Arm/Group Description:

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Overall Number of Participants Analyzed 33 33
Mean (Standard Error)
Unit of Measure: units on a scale per year
1.5728  (0.9743) 0.2315  (0.9702)
7.Secondary Outcome
Title Change in Slopes of EDSS From Baseline to Treatment Phase
Hide Description EDSS scale combines various elements of neurological exam. EDSS is a discrete scale ranging from 0 to 10 with 0.5 point increments. EDSS of 0 means no neurological disability, while EDSS of 10 marks death due to MS. EDSS was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase.The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.
Time Frame 1-year pre-treatment baseline vs 2-year treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
Arm/Group Title Idebenone Placebo
Hide Arm/Group Description:

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Overall Number of Participants Analyzed 33 33
Mean (Standard Error)
Unit of Measure: units on a scale per year
1.6148  (3.762) -3.7879  (3.7214)
Time Frame 3 years
Adverse Event Reporting Description First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
 
Arm/Group Title Untreated Idebenone Placebo
Hide Arm/Group Description Patients in their first year baseline prior to study drug phase

Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.

Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

Placebo tablets administered orally as five tablets, three times per day with food.

placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)

All-Cause Mortality
Untreated Idebenone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)      0/39 (0.00%)      2/38 (5.26%)    
Show Serious Adverse Events Hide Serious Adverse Events
Untreated Idebenone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/85 (14.12%)      11/39 (28.21%)      10/38 (26.32%)    
Blood and lymphatic system disorders       
Lymphadenopathy  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Eye disorders       
Diplopia  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Gastrointestinal disorders       
Nausea  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Constipation  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Cholecystectomy  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Peritoneal haemorrhage  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Intestinal obstruction  1  0/85 (0.00%)  0 0/39 (0.00%)  0 2/38 (5.26%)  2
Faecaloma  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
General disorders       
Chest pain  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Asthenia  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Condition aggravated  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Pain  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Peripheral swelling  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Pyrexia  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Vascular stent occlusion  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Cholecystitis acute  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Immune system disorders       
Sarcoidosis  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Infections and infestations       
Urinary tract infection  1  1/85 (1.18%)  1 1/39 (2.56%)  1 2/38 (5.26%)  2
Lyme disease  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Pneumonia  1  0/85 (0.00%)  0 0/39 (0.00%)  0 2/38 (5.26%)  2
Influenza  1  1/85 (1.18%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1
Localised infection  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Wound infection  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Escherichia urinary tract infecti  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Herpes zoster  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Sepsis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Injury, poisoning and procedural complications       
Fall  1  3/85 (3.53%)  3 2/39 (5.13%)  2 2/38 (5.26%)  2
Laceration  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Ankle fracture  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Fibula fracture  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Post lumbar puncture syndrome  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Skin abrasion  1  1/85 (1.18%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1
Upper limb fracture  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Joint injury  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Ligament rupture  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Tibia fracture  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Road traffic accident  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Alcohol poisoning  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Investigations       
H1N1 influenza  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Muscular weakness  1  0/85 (0.00%)  0 2/39 (5.13%)  2 0/38 (0.00%)  0
Muscle rigidity  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Muscle spasticity  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Spinal osteoarthritis  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Arthralgia  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Rheumatoid arthritis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Rotator cuff syndrome  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/85 (0.00%)  0 2/39 (5.13%)  2 0/38 (0.00%)  0
Trigeminal neuralgia  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Loss of consciousness  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Cervical cord compression  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Serotonin syndrome  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Cerebrovascular accident  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Diabetic hyperglycaemic coma  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Optic neuritis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Transient ischaemic attack  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Neurological symptom  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Psychiatric disorders       
Stress  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Mental status changes  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Renal and urinary disorders       
Dysuria  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Reproductive system and breast disorders       
Erectile dysfunction  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Dyspnoea  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Surgical and medical procedures       
Catheter management  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Coronary arterial stent insertion  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Intrathecal pump insertion  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Prostatectomy  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Spinal cord operation  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Umbilical hernia repair (AE)  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Antibiotic therapy  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Colostomy  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Occupational therapy  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Physical therapy  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Surgery  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Vascular disorders       
Deep vein thrombosis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Peripheral artery aneurysm  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Untreated Idebenone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/85 (32.94%)      15/39 (38.46%)      11/38 (28.95%)    
Blood and lymphatic system disorders       
Anaemia  1  5/85 (5.88%)  5 0/39 (0.00%)  0 0/38 (0.00%)  0
Lymphopenia  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Cardiac disorders       
Tachycardia  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Ear and labyrinth disorders       
Middle ear effusion  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  2
Hypoacusis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Vertigo  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Endocrine disorders       
Goitre  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Eye disorders       
Retinal detachment  1  0/85 (0.00%)  0 2/39 (5.13%)  2 0/38 (0.00%)  0
Cataract  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Eye movement disorder  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Glaucoma  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Gastrointestinal disorders       
Nausea  1  0/85 (0.00%)  0 1/39 (2.56%)  1 2/38 (5.26%)  3
Diarrhoea  1  0/85 (0.00%)  0 1/39 (2.56%)  1 2/38 (5.26%)  2
Vomiting  1  0/85 (0.00%)  0 1/39 (2.56%)  1 2/38 (5.26%)  2
Cholecystectomy  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Dental caries  1  1/85 (1.18%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1
Dry mouth  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Melaena  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
General disorders       
Oedema peripheral  1  1/85 (1.18%)  1 3/39 (7.69%)  4 1/38 (2.63%)  1
Chest pain  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Asthenia  1  0/85 (0.00%)  0 1/39 (2.56%)  1 2/38 (5.26%)  2
Condition aggravated  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Gravitational oedema  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Pain  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
General symptom  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Peripheral swelling  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Systemic inflammatory response sy  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Pyrexia  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Hepatobiliary disorders       
Hepatic lesion  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Infections and infestations       
Urinary tract infection  1  5/85 (5.88%)  8 2/39 (5.13%)  3 2/38 (5.26%)  2
Upper respiratory tract infection  1  1/85 (1.18%)  1 2/39 (5.13%)  2 0/38 (0.00%)  0
Lyme disease  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Cellulitis  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Post procedural infection  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Bacteriuria  1  1/85 (1.18%)  3 1/39 (2.56%)  1 0/38 (0.00%)  0
Acute sinusitis  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Pneumonia  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Influenza  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Body tinea  1  1/85 (1.18%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1
Localised infection  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Wound infection  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Gastritis viral  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Genital herpes  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Oral infection  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Sinusitis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Tinea versicolor  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Staphylococcal infection  1  1/85 (1.18%)  3 0/39 (0.00%)  0 0/38 (0.00%)  0
Onychomycosis  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  4/85 (4.71%)  4 3/39 (7.69%)  4 3/38 (7.89%)  4
Laceration  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Ankle fracture  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Procedural pain  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Foot fracture  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Hip fracture  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Spinal fracture  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Post lumbar puncture syndrome  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Upper limb fracture  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Hand fracture  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Skin injury  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Road traffic accident  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Arthropod bite  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Buttock injury  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Pelvic fracture  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Investigations       
Platelet function test abnormal  1  0/85 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1
Alanine aminotransferase increase  1  2/85 (2.35%)  2 1/39 (2.56%)  1 0/38 (0.00%)  0
Aspartate aminotransferase increa  1  2/85 (2.35%)  2 1/39 (2.56%)  1 0/38 (0.00%)  0
White blood cell count increased  1  0/85 (0.00%)  0 1/39 (2.56%)  2 0/38 (0.00%)  0
Antiphospholipid antibodies posit  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Blood creatine phosphokinase abno  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Prostatic specific antigen increa  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Retinal function test abnormal  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Blood creatine phosphokinase incr  1  1/85 (1.18%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1
Gamma-glutamyltransferase increas  1  1/85 (1.18%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1
Blood glucose increased  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Blood uric acid increased  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Occult blood positive  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Anti-thyroid antibody positive  1  1/85 (1.18%)  2 0/39 (0.00%)  0 0/38 (0.00%)  0
Blood alkaline phosphatase increa  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Blood creatinine abnormal  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Blood creatinine increased  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Blood urine  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Cystoscopy  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Glomerular filtration rate increa  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Mean cell volume abnormal  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Nuclear magnetic resonance imagin  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Platelet count decreased  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Prostate biopsy  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Metabolism and nutrition disorders       
Hyperkalaemia  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Gout  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Hyponatraemia  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  0/85 (0.00%)  0 3/39 (7.69%)  3 0/38 (0.00%)  0
Pain in extremity  1  1/85 (1.18%)  1 2/39 (5.13%)  2 0/38 (0.00%)  0
Musculoskeletal pain  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Groin pain  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Osteoarthritis  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Spinal column stenosis  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Arthralgia  1  2/85 (2.35%)  2 0/39 (0.00%)  0 1/38 (2.63%)  1
Osteoperosis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 2/38 (5.26%)  2
Arthritis  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Joint swelling  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Muscle injury  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Muscle spasms  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Muscle strain  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Bone lesion  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Haemarthrosis  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  1/85 (1.18%)  1 2/39 (5.13%)  2 1/38 (2.63%)  1
Nervous system disorders       
Trigeminal neuralgia  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Aphasia  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Cervical radiculopathy  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Migraine  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Paresthesia  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Somnolence  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Headache  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Seizure  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Psychiatric disorders       
Depression  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Sleep disorder  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Renal and urinary disorders       
Haematuria  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Micturition urgency  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Urinary incontinence  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Urinary retention  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Chromaturia  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Reproductive system and breast disorders       
Prostatitis  1  1/85 (1.18%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Nasal congestion  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Nasal crusting  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Asthma  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Pulmonary mass  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Rhinitis allergic  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Sleep apnoea syndrome  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  1/85 (1.18%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1
Decubitus ulcer  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Dermatitis  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Pityriasis rosea  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Rash  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Seborrhoeic dermatitis  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Surgical and medical procedures       
Catheter management  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Trigeminal nerve ablation  1  0/85 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0
Ear tube insertion  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Tooth extraction  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Vasectomy  1  0/85 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1
Endodontic procedure  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
Vascular disorders       
Peripheral venous disease  1  1/85 (1.18%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
The small sample size is a limitation of this study evaluating therapeutic intervention in a complex progressive neurological disease.
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. Bibiana Bielekova
Organization: National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: (240) 669-2724
EMail: bibi.bielekova@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00950248     History of Changes
Other Study ID Numbers: 090197
09-I-0197 ( Other Identifier: NIH )
First Submitted: July 30, 2009
First Posted: July 31, 2009
Results First Submitted: November 15, 2018
Results First Posted: March 7, 2019
Last Update Posted: March 19, 2019