Supported by the observation from the Phase I studies in healthy volunteers, doses within a range of 50 to 500 mg are safe and well tolerated. This Phase II trial will be performed to:a. obtain proof of concept of BI 44370 TAb. perform dose finding…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A pain free response, defined as reduction of severe or moderate headache to no
headache, 2 hours after dosing.
Secondary outcome
-Pain free response 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
-Pain relief, defined as reduction of severe or moderate headache to mild or no
headache 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
-Sustained pain free response, defined as reduction of severe or moderate
headache to no headache 2 hours after dosing and remaining pain free up to 24
and 48 hours after dosing.
-Sustained pain relief response, defined as reduction of severe or moderate
headache to mild or no headache 2 hours after dosing and no worsening up to 24
and 48 hours after dosing
-Intensity of headache at 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
-Relief of associated migraine symptoms at 0.5, 1, 1.5, 2, 24 and 48 hours
after dosing
-Time to meaningful relief, defined by the patient as occurring when relief of
pain and associated symptoms becomes meaningful, up to 2 hours after dosing
-Global evaluation of medication by the patient evaluated 48 hours after study
drug intake
-Functional disability assessed by the patient with the use of a 4-point scale,
measured at the time of intake of study medication, 0.5, 1, 1.5, 2, 24 and 48
hours after dosing
-Time to use of rescue medication within 24 and 48 hours
-Recurrence/relapse of headache during time-intervals of 2-24 and 2-48 hours
post dosing
-safety: incidence of adverse events and withdrawal because of adverse events
Background summary
Migraine is a condition of major public health concern, as approximately 12% of
the population (with a higher prevalence in women than in men) suffer from
recurrent migraine attacks that interfere with their daily lives. Standard
treatment options nowadays include triptans, ergot alkaloids,
asperin/metoclopramide, NSAIDs, opioids, combination analgesics and
antiemetics. However, migraine sufferers perceive a wide range of treatment
needs that are not fully met by currently available therapies. These include a
faster onset of action, a lower incidence of drug-induced side effects and an
improvement of response rate (usually 60-70%) and relapse rate (up to 40%)
BI 44370 TA is a noval putative drug which, on the basis of its mechanism of
action (ie.e. antagonism at the post junctional CGRP-receptor), is expected o
exert a beneficial effect on the pain of an acute migraine attack with a rapid
onset of action and good tolerability
Study objective
Supported by the observation from the Phase I studies in healthy volunteers,
doses within a range of 50 to 500 mg are safe and well tolerated. This Phase II
trial will be performed to:
a. obtain proof of concept of BI 44370 TA
b. perform dose finding and identify 2 doses for Phase III studies
Study design
This is a randomized, multi-centre, double-blind, double-dummy, parallel group
design. Three treatment arms of BI 44370 TA (50 mg, 200 mg and 400 mg) will be
compared with placebo. In addition, an active comparator (eletriptan 40 mg)
will be included for assay sensitivity and descriptive comparison. Patients
receive medication for one migraine attack.
Intervention
BI 4370 50 mg, 200 mg and 400 mg will be compared to placebo and an active
comparator: eletriptan 40 mg.
Study burden and risks
Use of BI 44370 may help to stop your acute migraine attack. Other medicines
which work the same way have previously shown beneficial effect in patients
with migraine attacks with few side effects. It is also possible that you will
have no direct benefit, except for satisfaction in knowing that the results of
this study could benefit other patients who suffer from migraine attacks.
Any medicine can have side effects. The known side effects of the medications
used in this trial are listed below. Should you not understand any of the
medical terms used in this list and want an explanation of them, please ask
your study doctor.
BI 44370
No drug-related side effects of BI 44370 have been observed in studies on
healthy volunteers. However, as with all new substances, use of BI 44370 may
have side effects which are not yet known.
Eletriptan
To date, eletriptan (RELPAX®) has been used in clinical trials in over 5000
patients, who took one or two 20 or 40 or 80 mg doses. The following side
effects (which occurred at least 1% more often than placebo) were reported:
Some common side effects could be: weakness, feeling tired or sleepy, nausea,
dizziness, sore throat and throat tightness, runny nose, headache, tingling or
abnormal sensation, muscle stiffness , reduced sense of touch or sensation,
palpitation or increased heart beat, abdominal pain, indigestion, dry mouth,
sweating, back pain, muscle pain, sensation of warmth or flushing, chest
symptoms (pain, tightness, pressure), chills.
Less common side effects could be: abnormal thinking, feeling agitated or
confused, feeling unwell or not feeling oneself, depression or euphoria,
sleeplessness, decreased appetite, tremor, increased sense of touch or
sensation, ataxia, slow movements, hoarseness or difficulty speaking, stupor,
taste disturbances, visual disturbances, eye pain, intolerance to light, dry or
watery eyes, earache, ringing in the ears, poor circulation, respiratory
disorders (shortness of breath), yawning, diarrhoea, inflammation of the
tongue, rash and itching, joint and bone pain, increased need to urinate, a
feeling of general discomfort or uneasiness, swelling of the face or hands and
feet, thirst.
Rare side effects could be: respiratory tract infection, swollen lymph nodes,
mood swings, conjunctivitis, slow heart beat, shock, asthma, voice alteration,
constipation, inflammation of the gullet, swelling of the tongue and belching,
jaundice and increased liver enzymes, skin disorder and hives, arthritis,
muscle weakness and twitching, breast pain and heavy periods.
Since Eletriptan has been commercially available, other side effects have been
reported such as: allergic reactions, some of which may be serious, rare cases
of syncope (fainting), increased blood pressure, rare reports of ischaemic
colitis, and vomiting.
Some patients taking triptans, such as eletriptan, may have a reaction called
serotonin syndrome particularly during combined use with certain types of
antidepressants, SSRIs or SNRIs. Symptoms may include confusion,
hallucinations, fast heart beat, feeling faint, fever, sweating, muscle spasm,
difficulty walking and/or diarrhoea. Call your doctor right away if you have
any of these symptoms.
Comeniusstraat 6
1817 MS Alkmaar
Nederland
Comeniusstraat 6
1817 MS Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
1. adult male and female migraine patients (age >=18 and <=65 years) with or withoug aura, diagnosed according to IHS criteria
2. established migraine diagnosis for >=1 year
3. age at migraine onset <=50 years
4. well documented history of migraine with headache of moderate to severe intensity, with attack duration of at least 6 hours and migraine frequency of 2-8 times/ month, during preceding 3 months (but not more than 12 days with migraine/month)
5. other forms of headache are permitted if they on avarage occur on not more than 10 days/month and if the patient is able to differentiate migraine headache from other forms of headache
6. if the patient is in general good health and is able to give written informed consent.
Exclusion criteria
1.history of hemiplegic, opthalmoplegic or basilar migraine, or cluster headache.
2.history of treatment resistant migraine attacks, defined as a lack of response to a range of commonly used acute anti-migraine compound, according to the investigator's judgement.
3.any other headache within 48 hours prior to taking study medication
4.other pain syndromes possibly interfering with study assessment or use of any pain medication >10 days/month. other restrictions as in section 4.2.2
5. use of migraine and other restricted medication listed in appendix 10.2 within time frames indicated in this appendix
6.female nursing or pregnant or of child-bearing potential who do not use during the clinical trial an adequate method of contraception.
7.men not willing to use adequate contraception during the whole study period from the time of the first intake of study drug ntill 3 months after the last intake.
8. in the judgment of the investigator suggestions of significant cardiovascular disease and/or peripheral vascular disease.
9. patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors unless cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of any significant cardiovascular disease.
10.findings suggestive of significant hepatic, respiratory, heamatological, gastrointestinal, renal, metabolic, immunological, hormonal, neurological and psychiatric disorders
11. known history of HIV, or cancer within the last 5 years
12. history of substance abuse or dependence within the past 6 months excluding nicotine and caffeine, but including alcohol or benzodiazepines.
13. history of relevant allergy and/or hypersensitivity
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000079-31-NL |
| ClinicalTrials.gov | NCT-nummernognietbekend |
| CCMO | NL23154.028.08 |