PM004

About this trial

Last updated 10 years ago

Study ID

PM004

Status

Terminated

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 65 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 10 years ago

The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.

Inclusion Criteria

- Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders [ICHD]-III beta).

- History of 1 to 6 migraine attacks per month for at least 12 previous months.

- At least 50% of previous migraine attacks had moderate or severe pain intensity.

- History of at least 48 hours of freedom from headache between migraine attacks.

- The majority of the previous untreated migraine attacks lasted at least 8 hours.

- Migraine onset before the age of 50 years.

Exclusion Criteria

- History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).

- More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).

- Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.

- Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.

- Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.

- Pronounced anterior septal nasal deviation.

Chordate System S020 Acute Migraine Clinical Investigation