Bumetanide in Hypokalaemic Periodic Paralysis

• Status: Terminated
• Trial end date: 2017-05-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Bumetanide

Criteria

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.