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Trial record 1 of 3 for:    HYPERKALEMIC PERIODIC PARALYSIS
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Hyper- and Hypokalemic Periodic Paralysis Study (HYP-HOP)

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ClinicalTrials.gov Identifier: NCT00494507
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : May 30, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Robert Griggs, MD, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hyperkalemic Periodic Paralysis
Hypokalemic Periodic Paralysis
Interventions Drug: Dichlorphenamide (double-blind)
Drug: Placebo (double-blind)
Drug: Dichlorphenamide (open-label)
Enrollment 71
Recruitment Details  
Pre-assignment Details The original trial design included an Acetazolamide (ACZ) drug arm which was subsequently removed. Five participants randomized to ACZ and one ineligible participant are not included in the trial results reported here.
Arm/Group Title HYP Dichlorphenamide HYP Placebo HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description

Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Period Title: Double-Blind Phase
Started 12 9 24 20
Reached Endpoint of Acute Worsening 0 2 0 5
Completed 9 9 22 19
Not Completed 3 0 2 1
Reason Not Completed
Adverse Event             2             0             1             0
Withdrawal by Subject             1             0             0             0
Subject Non-compliance             0             0             1             0
Negative DNA test             0             0             0             1
Period Title: Open-Label Phase
Started 9 8 [1] 22 19
Completed 9 7 17 14
Not Completed 0 1 5 5
Reason Not Completed
Adverse Event             0             1             5             3
Worsening Disease             0             0             0             2
[1]
1 subject randomized to Acetazolamide in this phase is not included-drug arm was removed from trial.
Arm/Group Title HYP Dichlorphenamide HYP Placebo HOP Dichlorphenamide HOP Placebo Total
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Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Total of all reporting groups
Overall Number of Baseline Participants 12 9 24 20 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 9 participants 24 participants 20 participants 65 participants
40.6  (10.3) 45.2  (17.7) 44.8  (14.6) 44.0  (15.6) 44.2  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 24 participants 20 participants 65 participants
Female
6
  50.0%
6
  66.7%
8
  33.3%
4
  20.0%
24
  36.9%
Male
6
  50.0%
3
  33.3%
16
  66.7%
16
  80.0%
41
  63.1%
1.Primary Outcome
Title HYP Attack Rate
Hide Description The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HYP participants.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 12 9
Median (Inter-Quartile Range)
Unit of Measure: attacks per week
0.9
(0.4 to 1.5)
4.8
(0.5 to 7.1)
2.Primary Outcome
Title HOP Attack Rate
Hide Description The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HOP participants.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 24 20
Median (Inter-Quartile Range)
Unit of Measure: attacks per week
0.3
(0.1 to 1.6)
2.4 [1] 
(0.5 to NA)
[1]
The upper quartile for the placebo group could not be calculated because more than 25% of placebo-treated subjects reached the endpoint of acute worsening.
3.Secondary Outcome
Title HYP Severity-weighted Attack Rate
Hide Description HYP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:

Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.

Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet

Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day

Overall Number of Participants Analyzed 12 9
Median (Inter-Quartile Range)
Unit of Measure: severity-weighted attacks per week
1.0
(0.4 to 2.9)
5.8
(1.4 to 28.0)
4.Secondary Outcome
Title HOP Severity-weighted Attack Rate
Hide Description HOP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 24 20
Median (Inter-Quartile Range)
Unit of Measure: severity-weighted attacks per week
0.6
(0.2 to 3.9)
5.7 [1] 
(1.2 to NA)
[1]
The upper quartile for the placebo group could not be calculated because more than 25% of placebo-treated subjects reached the endpoint of acute worsening and thus were assigned an arbitrarily large attack duration for purposes of analysis.
5.Secondary Outcome
Title HYP Attack Duration
Hide Description HYP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 12 9
Median (Inter-Quartile Range)
Unit of Measure: hours per week
10.5
(2.5 to 21.3)
39.4
(6.2 to 139.4)
6.Secondary Outcome
Title HOP Attack Duration
Hide Description HOP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 24 20
Median (Inter-Quartile Range)
Unit of Measure: hours per week
2.7
(0.4 to 13.4)
26.2 [1] 
(4.0 to NA)
[1]
The upper quartile for the placebo group could not be calculated because more than 25% of placebo-treated subjects reached the endpoint of acute worsening and thus were assigned an arbitrarily large attack duration for purposes of analysis.
7.Secondary Outcome
Title HYP Endpoint of Acute Worsening
Hide Description Increase in attack frequency or severity in HYP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.
Time Frame 0-9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 12 9
Measure Type: Number
Unit of Measure: participants
0 2
8.Secondary Outcome
Title HOP Endpoint of Acute Worsening
Hide Description Increase in attack frequency or severity in HOP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.
Time Frame 0-9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 24 20
Measure Type: Number
Unit of Measure: participants
0 5
9.Secondary Outcome
Title HYP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score
Hide Description

The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.

The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor.

Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.13  (0.26) 0.00  (0.16)
10.Secondary Outcome
Title HOP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score
Hide Description

The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.

The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor.

Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Overall Number of Participants Analyzed 23 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (0.21) -0.08  (0.15)
11.Secondary Outcome
Title HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores
Hide Description

The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.

The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right).

Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: Z-score
0.78  (0.52) 0.55  (0.76)
12.Secondary Outcome
Title HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores
Hide Description

The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.

The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right).

Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 21 15
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.08  (0.92) -0.27  (0.58)
13.Secondary Outcome
Title HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal
Hide Description

The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.

The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right).

Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: average percent of predicted normal
10.84  (8.27) 10.17  (14.54)
14.Secondary Outcome
Title HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal
Hide Description

The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.

The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right).

Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Overall Number of Participants Analyzed 21 15
Mean (Standard Deviation)
Unit of Measure: average percent of predicted normal
-0.81  (11.27) -2.94  (7.20)
15.Secondary Outcome
Title HYP Change From Baseline to Week 9 in Lean Body Mass
Hide Description Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).
Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had lean body mass data available at baseline and week 9.
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: kg
-1.31  (1.94) -1.52  (1.47)
16.Secondary Outcome
Title HOP Change From Baseline to Week 9 in Lean Body Mass
Hide Description Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).
Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had lean body mass data available at baseline and week 9.
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 22 15
Mean (Standard Deviation)
Unit of Measure: kg
-0.78  (1.65) 0.44  (2.39)
17.Secondary Outcome
Title HYP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score
Hide Description The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP,BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.
Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: T-score
3.16  (7.84) -0.11  (7.82)
18.Secondary Outcome
Title HOP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score
Hide Description The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP, BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.
Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: T-score
4.83  (7.23) -3.75  (10.61)
19.Secondary Outcome
Title HYP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score
Hide Description The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.
Time Frame Baseline and 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HYP Dichlorphenamide HYP Placebo
Hide Arm/Group Description:
Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: T-score
-3.77  (14.09) 2.65  (8.64)
20.Secondary Outcome
Title HOP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score
Hide Description The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.
Time Frame Baseline and 9 weeks
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Hide Analysis Population Description
Participants with evaluable data at both timepoints
Arm/Group Title HOP Dichlorphenamide HOP Placebo
Hide Arm/Group Description:
Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: T-score
-1.10  (9.93) -5.65  (12.58)
Time Frame [Not Specified]
Adverse Event Reporting Description

Adverse events were assessed via weekly phone calls with participants and at all study visits.

One HOP participant inadvertently remained on placebo during the open-label phase and therefore is not reported in the Other Adverse Events for the HOP Open-Label Dichlorphenamide group.

 
Arm/Group Title HYP Double-Blind Dichlorphenamide HYP Double-Blind Placebo HYP Open-Label Dichlorphenamide HOP Double-Blind Dichlorphenamide HOP Double-Blind Placebo HOP Open-Label Dichlorphenamide
Hide Arm/Group Description Hyperkalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase. Hyperkalemic participants were randomized to Placebo for the 9 week double-blind phase. Hyperkalemic participants received Dichlorphenamide for the 52 week open-label phase. Hypokalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase. Hypokalemic participants were randomized to Placebo for the 9 week double-blind phase. Hypokalemic participants received Dichlorphenamide for the 52 week open-label phase.
All-Cause Mortality
HYP Double-Blind Dichlorphenamide HYP Double-Blind Placebo HYP Open-Label Dichlorphenamide HOP Double-Blind Dichlorphenamide HOP Double-Blind Placebo HOP Open-Label Dichlorphenamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HYP Double-Blind Dichlorphenamide HYP Double-Blind Placebo HYP Open-Label Dichlorphenamide HOP Double-Blind Dichlorphenamide HOP Double-Blind Placebo HOP Open-Label Dichlorphenamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/9 (0.00%)      0/17 (0.00%)      0/24 (0.00%)      1/20 (5.00%)      3/40 (7.50%)    
Injury, poisoning and procedural complications             
Humerus fracture  1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/17 (0.00%)  0 0/24 (0.00%)  0 1/20 (5.00%)  1 0/40 (0.00%)  0
Road traffic accident  1 [1]  1/12 (8.33%)  1 0/9 (0.00%)  0 0/17 (0.00%)  0 0/24 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Thyroid cancer  1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/17 (0.00%)  0 0/24 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Adenocarcinoma  1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/17 (0.00%)  0 0/24 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders             
Cauda equina syndrome  1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/17 (0.00%)  0 0/24 (0.00%)  0 0/20 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders             
Rash  1  1/12 (8.33%)  1 0/9 (0.00%)  0 0/17 (0.00%)  0 0/24 (0.00%)  0 0/20 (0.00%)  0 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Occurred in the pre-treatment screening period.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HYP Double-Blind Dichlorphenamide HYP Double-Blind Placebo HYP Open-Label Dichlorphenamide HOP Double-Blind Dichlorphenamide HOP Double-Blind Placebo HOP Open-Label Dichlorphenamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/12 (75.00%)      3/9 (33.33%)      12/17 (70.59%)      20/24 (83.33%)      11/20 (55.00%)      32/40 (80.00%)    
Ear and labyrinth disorders             
EAR PAIN  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
TINNITUS  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
Eye disorders             
EYE PAIN  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
LACRIMATION INCREASED  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  0/40 (0.00%) 
PHOTOPSIA  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
VISION BLURRED  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  1/24 (4.17%)  0/20 (0.00%)  1/40 (2.50%) 
VISUAL DISTURBANCE  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  1/24 (4.17%)  1/20 (5.00%)  1/40 (2.50%) 
Gastrointestinal disorders             
ABDOMINAL PAIN UPPER  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  1/40 (2.50%) 
CONSTIPATION  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  2/40 (5.00%) 
DIARRHOEA  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  1/24 (4.17%)  1/20 (5.00%)  2/40 (5.00%) 
DRY MOUTH  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  1/24 (4.17%)  0/20 (0.00%)  2/40 (5.00%) 
NAUSEA  1  2/12 (16.67%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
VOMITING  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  1/40 (2.50%) 
General disorders             
ASTHENIA  1  0/12 (0.00%)  1/9 (11.11%)  1/17 (5.88%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
FATIGUE  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  3/24 (12.50%)  0/20 (0.00%)  4/40 (10.00%) 
MALAISE  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  2/24 (8.33%)  0/20 (0.00%)  0/40 (0.00%) 
OEDEMA  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
OEDEMA PERIPHERAL  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  2/40 (5.00%) 
PAIN  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
PYREXIA  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  1/24 (4.17%)  0/20 (0.00%)  0/40 (0.00%) 
Immune system disorders             
CORNEAL GRAFT REJECTION  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
Infections and infestations             
CELLULITIS  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
CYSTITIS ESCHERICHIA  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
INFECTION  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  1/40 (2.50%) 
INFLUENZA  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  1/40 (2.50%) 
NASOPHARYNGITIS  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  2/20 (10.00%)  3/40 (7.50%) 
PHARYNGITIS STREPTOCOCCAL  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
TONSILLITIS  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
Injury, poisoning and procedural complications             
CONCUSSION  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  0/40 (0.00%) 
FALL  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  1/24 (4.17%)  2/20 (10.00%)  5/40 (12.50%) 
HEAD INJURY  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  0/40 (0.00%) 
MUSCLE STRAIN  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
RIB FRACTURE  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
SPINAL FRACTURE  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
Investigations             
BLOOD CHOLESTEROL INCREASED  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
BLOOD GLUCOSE INCREASED  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
WEIGHT DECREASED  1  2/12 (16.67%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
Metabolism and nutrition disorders             
ANOREXIA  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  1/24 (4.17%)  1/20 (5.00%)  2/40 (5.00%) 
MUSCLE SPASMS  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  3/24 (12.50%)  0/20 (0.00%)  3/40 (7.50%) 
MUSCLE TWITCHING  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  2/24 (8.33%)  0/20 (0.00%)  1/40 (2.50%) 
MUSCULAR WEAKNESS  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  1/40 (2.50%) 
MUSCULOSKELETAL DISCOMFORT  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  0/40 (0.00%) 
MUSCULOSKELETAL STIFFNESS  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  0/40 (0.00%) 
MYALGIA  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  1/40 (2.50%) 
PAIN IN EXTREMITY  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  3/40 (7.50%) 
Nervous system disorders             
COGNITIVE DISORDER  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  5/24 (20.83%)  2/20 (10.00%)  8/40 (20.00%) 
DIZZINESS  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  2/24 (8.33%)  0/20 (0.00%)  1/40 (2.50%) 
DYSARTHRIA  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
DYSGEUSIA  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  4/24 (16.67%)  0/20 (0.00%)  5/40 (12.50%) 
HEADACHE  1  0/12 (0.00%)  1/9 (11.11%)  1/17 (5.88%)  3/24 (12.50%)  1/20 (5.00%)  3/40 (7.50%) 
HYPOAESTHESIA  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  3/24 (12.50%)  0/20 (0.00%)  1/40 (2.50%) 
LETHARGY  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  2/24 (8.33%)  0/20 (0.00%)  2/40 (5.00%) 
MEMORY IMPAIRMENT  1  0/12 (0.00%)  1/9 (11.11%)  2/17 (11.76%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
PARAESTHESIA  1  8/12 (66.67%)  3/9 (33.33%)  9/17 (52.94%)  9/24 (37.50%)  1/20 (5.00%)  12/40 (30.00%) 
POLYNEUROPATHY  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
Psychiatric disorders             
CONFUSIONAL STATE  1  2/12 (16.67%)  0/9 (0.00%)  1/17 (5.88%)  2/24 (8.33%)  0/20 (0.00%)  2/40 (5.00%) 
DEPRESSED MOOD  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  1/40 (2.50%) 
DEPRESSION  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
NERVOUSNESS  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
NIGHTMARE  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
Renal and urinary disorders             
NEPHROLITHIASIS  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  0/20 (0.00%)  3/40 (7.50%) 
Respiratory, thoracic and mediastinal disorders             
DYSPNOEA  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  1/24 (4.17%)  0/20 (0.00%)  0/40 (0.00%) 
PHARYNGOLARYNGEAL PAIN  1  1/12 (8.33%)  0/9 (0.00%)  0/17 (0.00%)  1/24 (4.17%)  0/20 (0.00%)  1/40 (2.50%) 
Skin and subcutaneous tissue disorders             
ACNE  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
DRY SKIN  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  1/24 (4.17%)  1/20 (5.00%)  1/40 (2.50%) 
OILY SKIN  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  0/40 (0.00%) 
PHOTOSENSITIVITY REACTION  1  0/12 (0.00%)  0/9 (0.00%)  0/17 (0.00%)  0/24 (0.00%)  1/20 (5.00%)  0/40 (0.00%) 
PRURITUS  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  1/24 (4.17%)  0/20 (0.00%)  1/40 (2.50%) 
RASH  1  1/12 (8.33%)  0/9 (0.00%)  1/17 (5.88%)  1/24 (4.17%)  1/20 (5.00%)  2/40 (5.00%) 
Surgical and medical procedures             
FOOT OPERATION  1  0/12 (0.00%)  0/9 (0.00%)  1/17 (5.88%)  0/24 (0.00%)  0/20 (0.00%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Sample sizes in the trial were limited by slow recruitment and the trial was concluded before attainment of the target numbers of subjects. Statistical analyses were conducted using smaller group sizes than planned, particularly for HYP subjects.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Robert Griggs, MD
Organization: University of Rochester
Phone: 585-275-3707
Responsible Party: Robert Griggs, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00494507     History of Changes
Other Study ID Numbers: R01NS045686-02 ( U.S. NIH Grant/Contract )
CRC ( Other Identifier: NINDS )
First Submitted: June 27, 2007
First Posted: June 29, 2007
Results First Submitted: April 30, 2014
Results First Posted: May 30, 2014
Last Update Posted: June 14, 2017