Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201412000967245 Date of Approval: 10/12/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pharmacological enhancement of motor function recovery in patients with ischaemic stroke: a trial of fluoxetine.
Official scientific title Pharmacological enhancement of motor function recovery in patients with ischaemic stroke: a trial of fluoxetine.
Brief summary describing the background and objectives of the trial Background: Cerebrovascular disease ( Stroke) is recognised as a major cause of morbidity and mortality amongst all populations and races. It is responsible for a high percentage of neurological admissions in Nigeria, and many medical deaths. The challenges of healthcare in the tropics and sub-Saharan Africa are well known with ridiculously high acute stroke mortality. Current medical advances in stroke including thrombolysis and revascularization remain the abstract contents of medical textbooks. Thus it becomes paramount that the stroke survivor has to contend with the residual neurological deficits with rehabilitation assuming a crucial place in the management of the stroke survivor. The benefits of optimizing the rate and quality of recovery during rehabilitation by addition of fluoxetine shall be studied. Objectives:To quantify and compare the mean changes in motor function using FMMS in both groups after 30 days. To identify a potential role for the pharmacological agent fluoxetine in motor function recovery following an ischaemic stroke, if commenced in the acute phase. To detect and measure changes in Fugl Myer motor scores of participants between enrolment and end of trial 30days later. Compare mean changes for both groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 01/06/2015
Actual Last follow-up date 30/06/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization, using blocks of 6, non-varied. Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group fluoxetine plus standard treatment 20mg 30days drug therapy 30
Control Group standard treatment standard treatment 30days therapy 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) 18- 85yrs of age (2) Ischaemic stroke, unilateral, supra-tentorialconfirmed by neuroimaging. (3) Presentation within first 14 days of ictus (4) NIHSS score </= 16 (5) Hemiparesis or hemiplegia, FMMS </=55 (6) Informed consent. (1) Glasgow coma score < 8, (2) NIHSS score >16 (3) Cardiovascular/metabolic /respiratory instability-: hypertensive emergency or hypotension/ acidosis or alkalosis/ RR >24cycles per min. (4) Previous central /peripheral nerve injury (5) Concurrent medications interacting with SSRI¿s (6) Haemorrhagic stroke on CT (7) Substantial premorbid disability (8) Depression (Montgomery-Åsberg Depression Rating Scale MADRS score >19), taking anti-depressant drugs, MAOI, neuroleptic drugs or benzodiazepines during the month before inclusion. (9) Pregnancy. (10) No consent. 18 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/10/2014 Uyo Institute of Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Uyo Teaching Hospital, Abak Road Uyo. Uyo 530001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in Fugl Meyr Motor score day 0 day 14 day 30
Secondary Outcome NIHSS, mRS day 0 day 30
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neurology Unit, Dept of Internal medicine, University of Uyo Teaching hospital, Uyo Abak Road Uyo Uyo 530001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
franklin Dike UUTH, Uyo Uyo 530001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor dike franklin UUTH, Uyo uyo 530001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof A. Ogunniyi UCH Ibadan Ibadan 200284 Nigeria
Dr Bertha Ekeh UUTH, Uyo Uyo 530001 Nigeria
Dr Udeme Ekrikpo UUTH, Uyo Uyo 530001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dike franklin frankincense4m@yahoo.com +2347033038651 Abak road Uyo
City Postal code Country Position/Affiliation
uyo 530001 Nigeria senior registrar
Role Name Email Phone Street address
Public Enquiries Dike franklin frankincense4m@yahoo.com +2347033038651 Abak road Uyo
City Postal code Country Position/Affiliation
uyo 530001 Nigeria senior registrar
Role Name Email Phone Street address
Scientific Enquiries Bertha Ekeh berthacekeh@yahoo.com +2348034018391 Abak road Uyo
City Postal code Country Position/Affiliation
Uyo 530001 Nigeria consultant neurologist
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information