Bumetanide in Hypokalaemic Periodic Paralysis

Phase 1

• Conditions: Hypokalaemic Periodic Paralysis; MedDRA version: 17.0 Level: PT Classification code 10016208 Term: Familial periodic paralysis System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-004195-36-GB
• Lead Sponsor: niversity College of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-04
• Study Completion: 2017-05-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1)At least 18 years of age;
2)Diagnosis of genetically confirmed HypoPP;
3)Clinical symptoms or signs of active symptomatic disease (at least 1 attack in last 12 months);
4)Practicing an acceptable method of birth control for the duration of the trial. Methods of birth control for women and men are addressed on Patient Information Sheet and on section section 11.4.5 of this protocol;

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1)Inability or unwillingness to provide informed consent;
2)People older than 64 years old;
3)Other conditions causing non-dominant hand weakness which could interfere with study measurements (e.g. due to a stroke, trauma or arthritis);
4)Patients with a history of cardiac disease, renal failure or 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;
5)Women who are pregnant or breast-feeding;
6)Patients with a previous history of diabetes, porphyria, symptomatic hypotension, prostatic hypertrophy or difficulty with micturition, or allergy to sulfonamides or thiazides;
7)Patients on lithium;
8)Patients known to be allergic to bumetanide or its excipients;
9)Patients with a history of inadequately treated Addison's disease;
10) Patients participating in another interventional trial in the previous 1 month.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified