Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03543254 |
Other study ID # |
2017/1490 |
Secondary ID |
2017-002516-13 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
May 1, 2018 |
Est. completion date |
January 1, 2021 |
Study information
Verified date |
January 2024 |
Source |
Norwegian University of Science and Technology |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
There is no doubt that chronic migraine is a large public health problem, which is both
disabling and costly. Many patients and headache doctors see Botulinum toxin (Botox)
treatment as a big stride forward, but it is a problem that the effect has been shown in only
one study, with a low therapeutic gain. For this reason, before this costly treatment is
expanded to potentially several thousand patients in Norway, it would be highly desirable
that 1) there is additional good scientific evidence for use of Botox , 2) a more effective
treatment procedure is developed, 3) the potential for unblinding is reduced, and 4) the
dose, number of injection sites and cost can be halved, and 5) the adverse effects are
minimized. These may be the results of this pilot project where injections are given along
the sutures, which can open up for a later randomized, blinded and controlled study.
Description:
The study is an an open-label, non-con trolled, single-arm and single-center phase II study,
at the outpatient clinic of the Department of Neurology and Clinical neurophysiology at St.
Olavs Hospital, Trondheim, Norway. The study was originally also planned at the Mayo Clinic,
Scottsdale, AZ, USA, but because the study there had not been started before the COVID-19
pandemic, the study was performed only in Trondheim. Potential study participants should be
identified among the regular outpatients at the Department of Neurology at St. Olavs
hospital. Potential participants should recceive an email with the informed consent form,
which should be signed at the screening visit where a detailed medical history and medical
examination should be per formed. Patients should complete a paper head ache diary, recording
pain intensity and duration, concomitant migraine symptoms (nausea, vomiting, phono- and
photophobia), acute medication (type, number of doses) and work absence (yes/no/not
relevant). Also, they should record any adverse events. After 7-14 days, they should receive
a telephone call from a nurse asking about adverse events and concom itant medication and
reminding them to maintain the daily diary. After a baseline period of at least 28 days,
diaries should be reviewed at a treatment visit, and each participant should receive
injections according to the described procedure. Women of child bearing potential should have
a negative pregnancy test before the injections. The duration of the injection procedure
should be measure with a stopwatch and immediately after the injections, the patient should
be asked to record on a VAS scale (0-10) the level of pain of the procedure and the
investigator recorded the degree of bleeding (no, mild, moderate, marked) and any other
injection-related adverse events (AEs). Patients should then be asked were asked to keep a
headache diary for another 12 weeks or more, before the end of the study visit. During this
period, they should receive a call from the study nurse at weeks 2 and 9, reminding to keep
the headache diary, and asking about AEs and concomitant medication. They should be also
asked whether they had noticed any change in their ability to make forehead wrinkles (no,
little, moderate, marked, full paralysis)