| Eligibility |
Inclusion Criteria:
- Written IRB-approved informed consent has been obtained and signed, within 12 months
of entering into the Baseline Period (Day -3).
- Male or female 18 years or older.
- Subject has =2 year history of episodic cluster headache with at least 2 previous
episodic cluster headache periods.
- Cluster Headaches must meet the following International Headache Society Diagnostic
Criteria :
- Severe, unilateral, orbital, superorbital and/or temporal pain lasting 15 to 180
minutes untreated.
- Headache is associated with at least one of the following which have to be
present on the side of the pain:
- Conjunctival injection
- Lacrimation
- Nasal Congestion
- Rhinorrhea
- Forehead and facial sweating
- Miosis
- Ptosis
- Eyelid edema or
- A sense of restlessness or agitation
- The current episodic cluster headache period is expected to last at least 5 weeks but
no more than 24 weeks from the time of entry into the Baseline Period (Day -3), based
on the average duration of the subject's usual episodic cluster headache period.
- At least one cluster headache (but no more than 8) daily on each of the three days of
the Baseline Period (Days -3, -2, -1) immediately preceding Study Day 1.
- The subject is in generally good health, other than history of episodic cluster
headache.
- The subject agrees not to begin any new concurrent medications or restricted
medications during their participation in study.
- All females of childbearing potential must have a negative urine and/or serum
pregnancy test prior to entry into the Treatment Period.
- Females of childbearing potential agree to use an approved form of birth control or to
abstain from sexual activity during the study.
- Subject can read and write in the local language and can be expected to reliably
follow study procedures.
Exclusion Criteria:
- Clinical, historical or previous laboratory evidence of significant cardiovascular,
renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (not including
cluster headaches), psychological, or other systemic disease that, in the opinion of
the investigator, might confound the results of the study or pose an additional risk
to the subject.
- Presence of a significant nasal disorder.
- Initiation of a medication, discontinuation of a medication or a change in the regimen
of existing medication(s) or therapies for prophylaxis of cluster headaches in the 17
days prior to entering the Treatment Period (Study Day 1).
- Use of systemic steroids to treat the current cluster headache episode.
- Use of restricted medications/treatments within the given time period prior to the
Treatment Period and throughout the study (Table 1 of Protocol)
- Subject has difficulty distinguishing his/her episodic cluster headache attacks from
other types of headaches, such as tension type headaches.
- Presence of chronic paroxysmal hemicrania, transformed migraine, or analgesic rebound
headaches.
- Females who are pregnant, breast-feeding, or planning to become pregnant during the
study.
- Subject has a history of alcohol and/or drug abuse within 12 months prior to the
Screening Visit..
- Subject has known hypersensitivity to or contraindication to the use of civamide,
capsaicin, or to any excipient of the clinical formulation.
- Subject has participated in another investigational study or taken another
investigational drug within the past 4 weeks.
- Subject has participated in prior efficacy studies of intranasal civamide:
WL-1001-02-01, WL-1001-02-02, WL-1001-02-03 or WL-1001-02-05. (This does not include
any subject who entered the screening period for study WL-1001-02-01, WL-1001-02-02,
WL-1001-02-03 or WL-1001-02-05 but did not randomize to treatment).
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