A multicentre, double-blind, placebo-controlled evaluation of intranasal sumatriptan delivered with the OptiNose powder device in the treatment of acute migraine.

• Conditions: Acute Treatment of Migraine with or without Aura; MedDRA version: 9.1Level: LLTClassification code 10027599Term: Migraine

• Registration Number: EUCTR2006-005991-41-CZ
• Lead Sponsor: OptiNose UK Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Adult subjects of either gender, aged 18-65 years.
2.A developing or established attack of migraine with or without aura according to the International Headache Society criteria, of moderate (grade 2) or severe (grade 3) intensity and the attack not improving at the time of assessment.
3.Migraine should have been present for at least 1 year and the subject should have a 3-month well-documented retrospective history.
4.The subject should have 48 hours of freedom from headache between attacks of migraine.
5.The subject’s age at first diagnosis of migraine should be less than 50 years.
6.An average of > 1 and < 6 migraine attacks per month for the past 6 months.
7.Female subjects of childbearing potential who practice an acceptable form of contraception and with a negative urine pregnancy test prior to dosing. Female subjects may be included without a negative urine pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
8.Subjects must report the migraine attack and attend the clinic within 4 hours of the onset of the attack.
9.Subjects must have verified airflow through both nostrils and an ability to close their soft palate.
10.Ability to create bidirectional flow using a placebo OptiNose powder device in accordance with the Instructions for Use with a nasal outflow of =20 L/min.
11.Willing and able to give written informed consent and comply with the study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.An inability to distinguish other headaches from migraine.
2.Subjects who have other headaches at a frequency of more than 6 days per month.
3.Subjects who use drugs excessively for headache, that is who use medication for acute headache more than 10 days each month.
4.Subjects who are resistant to migraine drugs.
5.Use of ergotamine, ergot-type medications, any 5-HT1 agonist or narcotic analgesics within the previous 24 hours before treatment.
6.Current use of drugs for migraine prophylaxis. Subjects who have used drugs for migraine prophylaxis in the past but have not done so for 1 month prior to the screening may be included.
7.Use of any analgesic within the previous 12 hours before treatment.
8.Subjects undergoing treatment with monoamine oxidase A (MAO-A) inhibitors or attending for treatment within 2 weeks of discontinuation of MAO-A inhibitor therapy.
9.Subjects undergoing treatment with selective serotonin reuptake inhibitors (SSRIs).
10.Subjects who have taken antipsychotics or antidepressant medications (unless for migraine prophylaxis) during the previous 3 months.
11.Subjects who have used a decongestant within 6 hours of their attendance at the clinic on the treatment day.
12.Subjects with hemiplegic or basilar migraine.
13.Subjects with a history, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes.
14.Subjects with uncontrolled hypertension (baseline systolic/diastolic blood pressure >140/95 mm Hg).
15.Subjects with severe hepatic impairment.
16.Subjects with epilepsy.
17.Subjects with any uncontrolled major psychiatric illness.
18.Subjects who abuse alcohol or other drugs.
19.Subjects with any systemic disease which in the opinion of the Investigator would contraindicate participation.
20.Subjects with a history of hypersensitivity or intolerance to sumatriptan, any of its components or sulphonamides.
21.Pregnant or lactating women.
22.Subjects who have taken any investigational medication within 3 months prior to the study drug (Visit 2), or are scheduled to receive an investigational drug other than sumatriptan while participating in the study.
23.Subjects with known nasal obstruction due to nasal deviations, polyposis, severe mucosal swelling or any other reason.
24.Subjects with current uncontrolled nasopharyngeal illness.
25.Subjects with known velum insufficiency, - i.e. those with cleft palate and/or structural abnormalities in the soft palate and nasopharynx.
26.Subjects who have undergone extensive nasal and/or sinus surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of intranasal sumatriptan at a dose of either 10 mg or 20 mg delivered with the OptiNose powder device during a single migraine episode.;Secondary Objective: To evaluate the safety and tolerability of intranasal sumatriptan at a dose of either 10 mg or 20 mg delivered with the OptiNose powder device during a single migraine episode.;Primary end point(s): - Proportion of subjects treated with sumatriptan pain free at 120 minutes post- dose compared to placebo.<br>- Relief of headache at each timepoint.<br>- Time to meaningful relief.<br>- Level of functional disability.<br>- Requirement for rescue medication.<br>- Incidence of associated symptoms.<br>- Sustained pain free.