Hyperkalemic Periodic ParalysisPhase 3HYP-HOPNCT00494507
Hyper- and Hypokalemic Periodic Paralysis Study
A Phase 3 study testing Dichlorphenamide (double-blind) and Dichlorphenamide (open-label) in people with Hyperkalemic Periodic Paralysis and Hypokalemic Periodic Paralysis, run by University of Rochester at 12 sites in 3 countries.
Trial summary
The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemic Periodic Paralysis, Hypokalemic Periodic Paralysis
- What is being tested?
- Dichlorphenamide (double-blind) and Dichlorphenamide (open-label)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jun 2007to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Genetically definite, clinically definite or clinically probable Hyperkalemic or Hypokalemic Periodic Paralysis as outlined in the protocol
- Male and female participants, age 18 and older who are able to comply with the study conditions.
- Participants who have distinct regular episodes of weakness with an average frequency of > or = to 1 a week and < or = to 3 a day either on or off treatment, whichever is higher
- Normal thyroid-stimulating hormone (TSH) level
Who cannot join
- Evidence for Andersen-Tawil syndrome (any one of the following 3 criteria)
- Prolonged QT interval or complex ventricular ectopy between attacks
- Distinctive physical features (2 of the following 5)
- Low set ears
- Short stature
- Hypo-/micrognathia
Show all 15Show fewer
- Clinodactyly
- Hypo-/hypertelorism
- KIR 2.1 gene mutation
- Coincidental renal, hepatic, active thyroid disease, restrictive or obstructive lung disease, other neuromuscular disease, or heart disease
- Chronic, non-congestive, angle-closure glaucoma
- Use of any of the following medications for reasons other than treatment of periodic paralysis: diuretics, antiarrhythmics, corticosteroids, beta-blockers, calcium channel blockers, antiepileptics, magnesium
- History of life-threatening episodes of respiratory muscle weakness or cardiac arrhythmias during attacks
- Pregnancy
- Known mutation in the alpha subunit of the sodium channel gene in hypokalemic periodic paralysis patients
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern-Dallas
Dallas, Texas, 75390
University of Kansas Medical Center
Kansas City, Kansas, 66160
UCLA Neurology
Los Angeles, California, 90095
Columbia University Medical Center
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
University of California-San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Dichlorphenamide vs. Placebo for Periodic Paralysis
The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis.
Read the detailed description
Periodic paralysis is a relatively rare, life-long disorder characterized by intermittent bouts of paralysis, progressive weakness, and diminished quality of life. Two drugs, acetazolamide (ACZ) and dichlorphenamide, have been prescribed to treat the disorder, however, dichlorphenamide is no longer available.
In this multi-center, parallel, randomized trial researchers will compare the effects of dichlorphenamide vs. placebo in patients with hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis.
The trial consists of two 9-week studies-one study will enroll persons with hyperkalemic periodic paralysis and the other study will enroll persons with hypokalemic periodic paralysis. Participants will be randomly assigned to one of two treatment groups: dichlorphenamide or placebo (an inactive substance). During the studies, participants will be asked to keep a daily diary to record the time, length, and severity of each episode of weakness (attack). The study coordinator will contact participants weekly to review the diary information.
The 9-week phase will be followed by a 1-year open-label dichlorphenamide extension without placebo to determine the long-term effects of dichlorphenamide on the course of the disease and on inter-attack weakness.
Duration of the trial for participants is approximately 65 weeks, including a screening phase to determine eligibility, the first 9-week treatment phase, and the one-year open-label extension phase.
- Being tested
- Dichlorphenamide (double-blind), Placebo (double-blind), Dichlorphenamide (open-label)
- Keywords
- periodic paralysis, dichlorphenamide
- Medical subject headings
- Paralysis, Hyperkalemic Periodic, Hypokalemic Periodic Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dichlorphenamide (double-blind)Drug
Also called Daranide
50mg tablet; maximum dosage 400mg/day
Placebo (double-blind)Drug
Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label)Drug
Also called Daranide
50mg tablet; maximum dosage 400mg/day
| Study group | Role | What they receive |
|---|---|---|
| HYP Dichlorphenamide | Active comparator | 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. Receives: Drug: Dichlorphenamide (double-blind); Drug: Dichlorphenamide (open-label) |
| HYP Placebo | Placebo comparator | 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. Receives: Drug: Placebo (double-blind); Drug: Dichlorphenamide (open-label) |
| HOP Dichlorphenamide | Active comparator | 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. Receives: Drug: Dichlorphenamide (double-blind); Drug: Dichlorphenamide (open-label) |
| HOP Placebo | Placebo comparator | 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. Receives: Drug: Placebo (double-blind); Drug: Dichlorphenamide (open-label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HYP Attack Rate
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.
Measured: 8 weeks
HOP Attack Rate
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.
Measured: 8 weeks
Secondary outcomes (18)
HYP Severity-weighted Attack Rate
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.
Measured: 8 weeks
HOP Severity-weighted Attack Rate
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.
Measured: 8 weeks
HYP Attack Duration
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.
Measured: 8 weeks
HOP Attack Duration
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.
Measured: 8 weeks
HYP Endpoint of Acute Worsening
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.
Measured: 0-9 weeks
HOP Endpoint of Acute Worsening
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.
Measured: 0-9 weeks
HYP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score
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.
Measured: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score
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.
Measured: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores
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).
Measured: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores
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).
Measured: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal
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).
Measured: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal
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).
Measured: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in Lean Body Mass
Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Lean Body Mass
Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score
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.
Measured: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score
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.
Measured: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score
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.
Measured: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score
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.
Measured: Baseline and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hyperkalemic Periodic ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Robert Griggs, MD, University of Rochester
- Investigators
- Robert C. Griggs, M.D., Principal investigator, University of RochesterRabi Tawil, M.D., Principal investigator, Co-Principal Investigator, University of RochesterMichael McDermott, Ph.D., Biostatistician, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494507
- Sponsor's protocol ID
- R01NS045686-02
- Other IDs
- CRC
- Acronym
- HYP-HOP
- Status last verified
- May 2017
- First submitted
- 27 Jun 2007
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dichlorphenamide vs. Placebo for Periodic Paralysis
- ClinicalTrials.gov ID
- NCT00494507
- Acronym / sponsor ID
- HYP-HOP / R01NS045686-02
- Keywords
- periodic paralysis, dichlorphenamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 30 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis.
Detailed description
Periodic paralysis is a relatively rare, life-long disorder characterized by intermittent bouts of paralysis, progressive weakness, and diminished quality of life. Two drugs, acetazolamide (ACZ) and dichlorphenamide, have been prescribed to treat the disorder, however, dichlorphenamide is no longer available.
In this multi-center, parallel, randomized trial researchers will compare the effects of dichlorphenamide vs. placebo in patients with hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis.
The trial consists of two 9-week studies-one study will enroll persons with hyperkalemic periodic paralysis and the other study will enroll persons with hypokalemic periodic paralysis. Participants will be randomly assigned to one of two treatment groups: dichlorphenamide or placebo (an inactive substance). During the studies, participants will be asked to keep a daily diary to record the time, length, and severity of each episode of weakness (attack). The study coordinator will contact participants weekly to review the diary information.
The 9-week phase will be followed by a 1-year open-label dichlorphenamide extension without placebo to determine the long-term effects of dichlorphenamide on the course of the disease and on inter-attack weakness.
Duration of the trial for participants is approximately 65 weeks, including a screening phase to determine eligibility, the first 9-week treatment phase, and the one-year open-label extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HYP Dichlorphenamide | Active comparator | Drug: Dichlorphenamide (double-blind), Drug: Dichlorphenamide (open-label)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. |
| HYP Placebo | Placebo comparator | Drug: Placebo (double-blind), Drug: Dichlorphenamide (open-label)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. |
| HOP Dichlorphenamide | Active comparator | Drug: Dichlorphenamide (double-blind), Drug: Dichlorphenamide (open-label)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. |
| HOP Placebo | Placebo comparator | Drug: Placebo (double-blind), Drug: Dichlorphenamide (open-label)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Genetically definite, clinically definite or clinically probable Hyperkalemic or Hypokalemic Periodic Paralysis as outlined in the protocol
- Male and female participants, age 18 and older who are able to comply with the study conditions.
- Participants who have distinct regular episodes of weakness with an average frequency of > or = to 1 a week and < or = to 3 a day either on or off treatment, whichever is higher
- Normal thyroid-stimulating hormone (TSH) level
Key exclusion criteria (15 listed)
- Evidence for Andersen-Tawil syndrome (any one of the following 3 criteria)
- Coincidental renal, hepatic, active thyroid disease, restrictive or obstructive lung disease, other neuromuscular disease, or heart disease
- Chronic, non-congestive, angle-closure glaucoma
- Use of any of the following medications for reasons other than treatment of periodic paralysis: diuretics, antiarrhythmics, corticosteroids, beta-blockers, calcium channel blockers, antiepileptics, magnesium
- History of life-threatening episodes of respiratory muscle weakness or cardiac arrhythmias during attacks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dichlorphenamide (double-blind)Also: Daranide50mg tablet; maximum dosage 400mg/day | Drug | HOP Dichlorphenamide, HYP Dichlorphenamide |
| Placebo (double-blind)Inactive substance manufactured to look like Dichlorphenamide 50mg tablet | Drug | HOP Placebo, HYP Placebo |
| Dichlorphenamide (open-label)Also: Daranide50mg tablet; maximum dosage 400mg/day | Drug | HOP Dichlorphenamide, HOP Placebo, HYP Dichlorphenamide, HYP Placebo |
Primary outcome
HYP Attack Rate
Time frame: 8 weeks
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.
HOP Attack Rate
Time frame: 8 weeks
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.
18 secondary outcomes
HYP Severity-weighted Attack Rate
Time frame: 8 weeks
HOP Severity-weighted Attack Rate
Time frame: 8 weeks
HYP Attack Duration
Time frame: 8 weeks
HOP Attack Duration
Time frame: 8 weeks
HYP Endpoint of Acute Worsening
Time frame: 0-9 weeks
HOP Endpoint of Acute Worsening
Time frame: 0-9 weeks
HYP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score
Time frame: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score
Time frame: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores
Time frame: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores
Time frame: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal
Time frame: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal
Time frame: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in Lean Body Mass
Time frame: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in Lean Body Mass
Time frame: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score
Time frame: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score
Time frame: Baseline and 9 weeks
HYP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score
Time frame: Baseline and 9 weeks
HOP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score
Time frame: Baseline and 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hyperkalemic Periodic Paralysis
Recruiting
Effect of Physical Training in Individuals With Hypokalemic and Hyperkalemic Periodic Paralysis
Hypokalemic Periodic Paralysis, Hyperkalemic Periodic Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Griggs, M.D. principal investigator
University of Rochester
Rabi Tawil, M.D. principal investigator
Co-Principal Investigator, University of Rochester
Michael McDermott, Ph.D.
Biostatistician, University of Rochester
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dichlorphenamide (double-blind) and Dichlorphenamide (open-label) in people with Hyperkalemic Periodic Paralysis and Hypokalemic Periodic Paralysis, run by University of Rochester at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HYP Attack Rate (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.