Clinical trial NCT00285402: Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine
Official title: Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Migraine
Migraine Headache
Migraine Disorders
Migraine With Aura
Migraine Without Aura
Keywords: Migraine
Migraine prophylaxis
Migraine prevention
Chronic migraine treatment
Lead sponsor: Ariston Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-02
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this migraine prevention study is to evaluate the efficacy and safety of AST-726 in moderate to severe migraine patients at one of two doses compared to placebo and compared to a baseline period as measured by a reduction in the number of migraine days.

Detailed description: Migraine patients may experience repeated migraine attacks, lasting from four hours to three days or more. Each attack is characterized by severe pain, typically on one side of the head and often involves a number of other symptoms, including pain with a pulsating or throbbing quality, nausea or vomiting, sensitivity to light and sound, visual disturbances or aura. Currently the management of migraine may be either acute treatment or prophylaxis. Acute migraine treatment aims at aborting or reversing already present migraine symptoms with acute administration of medicine such as with triptans, whereas migraine prophylaxis aims to reduce the frequency and severity of migraine attacks over time through chronic medication.

The overall protocol design and outcome measurements of this study follow the guidelines and durations recommended by the International Headache Society for prophylaxis studies of migraine medications.

The study ARPH-CL-03 is a multicenter, randomized, double-blind, three parallel group design with moderate to severe migraine patients to assess the ability of daily administration of AST-726 at one of two doses to reduce the number of headache days in a 4 week period more than in patients that receive a placebo. AST-726 and the placebo will be self-administered by intranasal spray daily for 12 weeks. Among other efficacy and safety assessments, patients will have be asked to collect information on a daily migraine diary.

Patients will be instructed on the allowed use of acute migraine medications during this study.

Eligibility criteria: Primary Inclusion Criteria:

1. Has migraine headaches with or without aura according to International Headache Society guidelines (Committee, 2004).
2. Has had migraines for at least 6 months prior to study enrollment period.
3. Migraines began before age 50.
4. Has 2 to 10 attacks per month and greater than or equal to 3 migraine days per month in the last 3 months prior to study enrollment.
5. Has 2 to 10 attacks in 30 days during the Baseline Period.

Additional inclusion criteria in protocol

Primary Exclusion Criteria:

1. Has headache equal to or greater than 18 days per month.
2. Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use within 60 days prior to study enrollment.
3. Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine \[DHE\]) greater than 15 days per month.
4. Has taken nitroglycerine-containing medications within 60 days prior to study enrollment.
5. Failed more than 3 clinical studies of effective migraine prevention medications due to uncontrolled migraines.

Additional exclusion criteria in protocol

Primary outcomes:
measure: The primary outcome variable will be change in number of migraine headache days during standardized 30-day observation periods during treatment period and baseline period. The number of headache days reported in the patient diary will be standardized.
timeFrame: 30 days
Secondary outcomes:
measure: 1 Number of subjects that respond with at least a 50% decrease in migraine days in each given 4-week Treatment Period
timeFrame: 4 weeks
measure: 2 The number of migraine headache attacks in each treatment period
timeFrame: 3 months
Other outcomes:
Locations:
city: Koskenalantie 16
country: Finland
facility: Mediwest Research Centre Oy
state: Seinajoki
city: Brahenkatu 11D, Turku
country: Finland
facility: Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)
state: Turku
city: Jyvaskyla
country: Finland
facility: Suomen Terveystalo Jyvaskyla
state: Vainonkatu 30
city: Hameenkatu 18 6th Floor, Tampere
country: Finland
facility: Headache Center, Tammertutka
city: Itsenalsyydenk. 33, Pori
country: Finland
facility: Porin Laakerikeskus
city: Groot Wezenland 20
country: Netherlands
facility: Isala Kliniek
state: Zwolle
city: Geerdinksweg 141, Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente, Afdeling Neurolgie , Locatie Streekziekenhuis Midden Twente
city: Geldrop
country: Netherlands
facility: St Anna Hospital, Bogardeind 2
city: Weg door Jonkerbos 100 SZ Nimegen
country: Netherlands
facility: Canisius Wilhelmina Hospital, Afdeling C02.04
city: Fowey
country: United Kingdom
facility: The Fowey River Practice; Rawlings Lane
state: Cornwall
city: Penzance
country: United Kingdom
facility: The Alverton Practice, 7 Alverton Terrace
state: Cornwall
city: Saltash
country: United Kingdom
facility: Saltash Health Centre
state: Cornwall
city: Soham
country: United Kingdom
facility: The Staploe Medical Centre
state: Eky
city: Farnworth BL4 9QZ Bolton
country: United Kingdom
facility: Stonehill Medical Centre, Piggot st.
state: Lancashire
city: Ashford
country: United Kingdom
facility: Stanwell Road Surgery, 25 Stanwell Road
state: Middlesex
city: Harrow
country: United Kingdom
facility: The Circle Practice/Belmont Health Centre
state: Middlesex
city: Devon
country: United Kingdom
facility: Woolwell Medical Centre
state: Plymouth
city: East Horsley
country: United Kingdom
facility: The Medical Centre, Kingston ave
state: Surrey
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre, 3 Queen St.
Study officials:
affiliation: Canisius-Wilhelmina Zeikenhuis
name: W. M. Mulleners
role: PRINCIPAL_INVESTIGATOR
References: