Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine

NCT ID: NCT00285402

Last Updated: 2008-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-06-30

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.

Conditions

Migraine; Migraine Headache; Migraine Disorders; Migraine With Aura; Migraine Without Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

A

Group Type: EXPERIMENTAL

AST-726 Low dose

Intervention Type: DRUG

B

Group Type: EXPERIMENTAL

AST-726 High dose

Intervention Type: DRUG

C

Group Type: PLACEBO_COMPARATOR

AST-726 Placebo

Intervention Type: DRUG

Interventions

AST-726 Low dose

Intervention Type: DRUG

AST-726 High dose

Intervention Type: DRUG

AST-726 Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariston Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Ariston Pharmaceuticals, Inc

Principal Investigators

W. M. Mulleners

Role: PRINCIPAL_INVESTIGATOR

Canisius-Wilhelmina Zeikenhuis

Locations

Mediwest Research Centre Oy

Koskenalantie 16, Seinajoki, Finland

Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)

Brahenkatu 11D, Turku, Turku, Finland

Suomen Terveystalo Jyvaskyla

Jyväskylä, Vainonkatu 30, Finland

Headache Center, Tammertutka

Hameenkatu 18 6th Floor, Tampere, , Finland

Porin Laakerikeskus

Itsenalsyydenk. 33, Pori, , Finland

Isala Kliniek

Groot Wezenland 20, Zwolle, Netherlands

Ziekenhuisgroep Twente, Afdeling Neurolgie , Locatie Streekziekenhuis Midden Twente

Geerdinksweg 141, Hengelo, , Netherlands

St Anna Hospital, Bogardeind 2

Geldrop, , Netherlands

Canisius Wilhelmina Hospital, Afdeling C02.04

Weg Door Jonkerbos 100 SZ Nimegen, , Netherlands

The Fowey River Practice; Rawlings Lane

Fowey, Cornwall, United Kingdom

The Alverton Practice, 7 Alverton Terrace

Penzance, Cornwall, United Kingdom

Saltash Health Centre

Saltash, Cornwall, United Kingdom

The Staploe Medical Centre

Soham, Eky, United Kingdom

Stonehill Medical Centre, Piggot st.

Farnworth BL4 9QZ Bolton, Lancashire, United Kingdom

Stanwell Road Surgery, 25 Stanwell Road

Ashford, Middlesex, United Kingdom

The Circle Practice/Belmont Health Centre

Harrow, Middlesex, United Kingdom

Woolwell Medical Centre

Devon, Plymouth, United Kingdom

The Medical Centre, Kingston ave

East Horsley, Surrey, United Kingdom

Albany House Medical Centre, 3 Queen St.

Wellingborough, , United Kingdom

Countries

Finland; Netherlands; United Kingdom

Other Identifiers

Eudract no: 2005-003349-15

Identifier Type: -

Identifier Source: secondary_id

ARPH-Cl-03

Identifier Type: -

Identifier Source: org_study_id