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

Migraine Clinical Trial

Official title:

Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00285402
• Other study ID #: ARPH-Cl-03
• Secondary ID: Eudract no: 2005
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 31, 2006
• Last updated: February 6, 2008
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: February 2008
• Source: Ariston Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyFinland: Finnish Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 198
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine Headache
• Migraine With Aura
• Migraine without Aura

Intervention

Drug:
• AST-726 Low dose

• AST-726 High dose

• AST-726 Placebo

Locations

Country	Name	City	State
Finland	Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)	Brahenkatu 11D, Turku	Turku
Finland	Headache Center, Tammertutka	Hameenkatu 18 6th Floor, Tampere
Finland	Porin Laakerikeskus	Itsenalsyydenk. 33, Pori
Finland	Suomen Terveystalo Jyvaskyla	Jyvaskyla	Vainonkatu 30
Finland	Mediwest Research Centre Oy	Koskenalantie 16	Seinajoki
Netherlands	Ziekenhuisgroep Twente, Afdeling Neurolgie , Locatie Streekziekenhuis Midden Twente	Geerdinksweg 141, Hengelo
Netherlands	St Anna Hospital, Bogardeind 2	Geldrop
Netherlands	Isala Kliniek	Groot Wezenland 20	Zwolle
Netherlands	Canisius Wilhelmina Hospital, Afdeling C02.04	Weg door Jonkerbos 100 SZ Nimegen
United Kingdom	Stanwell Road Surgery, 25 Stanwell Road	Ashford	Middlesex
United Kingdom	Woolwell Medical Centre	Devon	Plymouth
United Kingdom	The Medical Centre, Kingston ave	East Horsley	Surrey
United Kingdom	Stonehill Medical Centre, Piggot st.	Farnworth BL4 9QZ Bolton	Lancashire
United Kingdom	The Fowey River Practice; Rawlings Lane	Fowey	Cornwall
United Kingdom	The Circle Practice/Belmont Health Centre	Harrow	Middlesex
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	Albany House Medical Centre, 3 Queen St.	Wellingborough

Sponsors (1)

Lead Sponsor	Collaborator
Ariston Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Finland,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 days	No
Secondary	1 Number of subjects that respond with at least a 50% decrease in migraine days in each given 4-week Treatment Period		4 weeks	No
Secondary	2 The number of migraine headache attacks in each treatment period		3 months	No