Bumetanide in Hypokalaemic Periodic Paralysis (NCT02582476) | Clinical Trial Compass
TerminatedPhase 2
Bumetanide in Hypokalaemic Periodic Paralysis
Stopped: Slow enrolment and end of funding
United Kingdom12 participantsStarted 2015-01
Plain-language summary
This is a randomised, double-blind, placebo-controlled phase II clinical trial with a cross-over design to investigate the efficacy of bumetanide in patients with hypokalemic periodic paralysis (HypoPP).
The aim is to assess the efficacy of bumetanide in reducing severity and duration of a focal attack of weakness in a hand muscle.
Twelve participants will be recruited.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* At least 18 years of age;
* Diagnosis of genetically confirmed HypoPP;
* Clinical symptoms or signs of active symptomatic disease (at least 1 attack in last 12 months);
* Practising an acceptable method of birth control for the duration of the trial. This will be addressed on Patient Information Sheet for men and women (section 11.4.5);
Exclusion Criteria:
* Inability or unwillingness to provide informed consent;
* People older than 64 years old;
* Other conditions causing hand weakness which could interfere with study measurements (e.g. due to a stroke, trauma or arthritis)
* Patients with a history of cardiac disease, renal failure or moderate to severe hepatic disease. Note: abnormalities in serum transaminases are common in people with HypoPP as they arise from skeletal muscle rather than any specific liver abnormality. Consequently, raised serum bilirubin \>20% above the baseline value will be used to identify abnormal liver function;
* Women who are pregnant or breast-feeding;
* Patients with a current or previous history of diabetes, porphyria, symptomatic hypotension, prostatic hypertrophy or difficulty with micturition, allergy to sulfonamides or thiazides;
* Patients on lithium, digoxin, nephro- or ototoxic drugs;
* Patients known to be allergic bumetanide or its excipients;
* Patients with a history of inadequately treated Addison's disease;
* Patients participating in another interventional trial in the previous 1 month.
What they're measuring
1
Focal attack severity one hour after treatment
Timeframe: The effect of treatment on focal attack severity one hour after treatment