Allopurinol in Functional Impairment (ALFIE) Trial ‘Improving muscle strength’

Phase 1

• Conditions: FUNCTIONAL IMPAIRMENT; MedDRA version: 19.0 Level: LLT Classification code 10065629 Term: Decreased exercise endurance System Organ Class: 100000004867; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-004122-18-GB
• Lead Sponsor: niversity of Dundee, Tayside Clinical Trials Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 124

Inclusion Criteria

• Age 65 and over
• 6-Minute Walk Distance less than 400m

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 124

Exclusion Criteria

-Documented history of peripheral arterial disease
-Pre-existing diagnosis of severe heart failure (LVEF<35%)
-Malignancy under active treatment (excluding basal cell carcinoma)
-Severe COPD (Physician diagnosis)
-Intolerance to allopurinol
-On long term high dose steroids (eq. Prednisolone>10mg/day due to risk of steroid induced myopathy and osteoporosis)
-Immobility that would render the patient incapable of doing the Short Physical Performance Battery Test (SPPB) or 6MWT
-Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded
-Cognitive impairment precluding informed consent
-Patients with active acute gout
-Patients who have had allopurinol in the previous 30 days or those on long-term allopurinol
-Patients with chronic kidney disease with an eGFR of 30ml/ or less
-Patients who have contraindications to MRS scanning
As the leg is the only part of the body in the scanner (unlike traditional MRI) we will not specifically exclude patients who have claustrophobia. Should they still not wish to take part, this is covered under the exclusion criteria: Any other considered by a study physician to be inappropriate for inclusion”
-Patients who are allergic or contraindicated to GTN should be excluded from undertaking FMD
-Any other considered by a study physician to be inappropriate for inclusion

Study & Design

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