[GP name]
[GP address]
14 March 2016
Dear Dr [GP name]
IIH:DT. Assessing the therapeutic efficacy of an 11β-hydroxysteroid dehydrogenase type 1
inhibitor (AZD4017) in idiopathic intracranial hypertension (IIH). Phase II Study.
Re: [participant name], [participant DOB], [participant address]
This patient has been identified, from the [insert clinic] at the [insert hospital], as being
potentially suitable to take part in the above clinical trial. The study is sponsored by the
University of Birmingham (Chief Investigator: Dr Alexandra Sinclair) and is being organised
locally in association with the Neuro-opthalmology department and the Wellcome Trust
Birmingham Clinical Research Facility (WTCRF). Participants enrolled onto the study will have
clinical measurements, biochemical markers, safety monitoring, visual assessments, 24-hour
urinary steroid profiles, lumbar punctures with CSF sampling, DXA scanning and fat and skin
biopsies. Each participant will be involved in the study for approximately 4 months and be asked
to attend 8 visits to the WTCRF and 4 telephone consultations. Patients can continue their IIH
treatment e.g. acetazolamide, but this must remain at a stable dose throughout the study. The
aims of the study are to assess the impact of an 11β-hydroxysteroid dehydrogenase type 1
inhibitor on intracranial pressure, papilloedema, symptoms of IIH, and to assess the safety
profile of the drug in this population.
The patient has been invited to participate in the study, either after discussing the study with a
nurse or investigator in clinic, by phone after their visit to the WTCRF or by an invitation mailing
following their visit. The patient has been given a brief overview of the study and the option to
express an interest in being contacted by research staff to discuss the study further. No
involvement is required from your practice. If they agree to participate in the study please do
not change any idiopathic intracranial treatment or start hormone-manipulating medications
without notifying the research team. When their study visits are complete or they decide not to
continue with the study we will write to you to commence any treatment.
If you have any queries regarding the study, please do not hesitate to contact me on 0121 371
3718.
.
IIH:DT GP Letter 1
V1.2. 141014
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Figure 1. IIH:DT Study Flow Chart
Assessed for Eligibility
Screening and enrolment
(Week 0)
N=30
Randomised 1:1
Treatment with
AZD4017
N=15
Treatment with
Placebo
Dropouts
N=15
Dropouts
Follow-up (Week 1,2,3,4,6,8,10)
N=12
End of study (Week 12)
N=12
Post-study Follow-up (Week 16)
Thank you for your help.
Yours sincerely
Dr Keira Markey
Clinical Research Fellow to Dr Alexandra Sinclair
University of Birmingham.
.
IIH:DT GP Letter 1
V1.2. 141014
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