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

NCT00285402 | Unknown Phase 2

• 2 other identifiers: ARPH-Cl-03Eudract no: 2005-003349-15
• Study Type: interventional
• Target: 198
• Locations: 3 countries
• Sites: 19

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.

Conditions

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

Keywords

Migraine; Migraine prophylaxis; Migraine prevention; Chronic migraine treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 1 Number of subjects that respond with at least a 50% decrease in migraine days in each given 4-week Treatment Period

  4 weeks

• 2 The number of migraine headache attacks in each treatment period

  3 months

Study Arms (3)

A

EXPERIMENTAL

Drug: AST-726 Low dose

B

EXPERIMENTAL

Drug: AST-726 High dose

C

PLACEBO COMPARATOR

Drug: AST-726 Placebo

Interventions

AST-726 Low dose DRUG

A

AST-726 High dose DRUG

B

AST-726 Placebo DRUG

C

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has migraine headaches with or without aura according to International Headache Society guidelines (Committee, 2004).
• Has had migraines for at least 6 months prior to study enrollment period.
• Migraines began before age 50.
• 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.
• Has 2 to 10 attacks in 30 days during the Baseline Period.

You may not qualify if:

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

Sponsors & Collaborators

• Ariston Pharmaceuticals, Inc.: lead

Study Sites (19)

Mediwest Research Centre Oy

Koskenalantie 16, Seinajoki, 60220, Finland

Location

Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)

Brahenkatu 11D, Turku, Turku, 20100, Finland

Location

Suomen Terveystalo Jyvaskyla

Jyväskylä, Vainonkatu 30, 40100, Finland

Location

Headache Center, Tammertutka

Hameenkatu 18 6th Floor, Tampere, 33200, Finland

Location

Porin Laakerikeskus

Itsenalsyydenk. 33, Pori, 28100, Finland

Location

Isala Kliniek

Groot Wezenland 20, Zwolle, 8000, Netherlands

Location

Ziekenhuisgroep Twente, Afdeling Neurolgie , Locatie Streekziekenhuis Midden Twente

Geerdinksweg 141, Hengelo, 7555, Netherlands

Location

St Anna Hospital, Bogardeind 2

Geldrop, 5664, Netherlands

Location

Canisius Wilhelmina Hospital, Afdeling C02.04

Weg Door Jonkerbos 100 SZ Nimegen, 6532, Netherlands

Location

The Fowey River Practice; Rawlings Lane

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

The Alverton Practice, 7 Alverton Terrace

Penzance, Cornwall, TR18 4JH, United Kingdom

Location

Saltash Health Centre

Saltash, Cornwall, PL 12 6DI, United Kingdom

Location

The Staploe Medical Centre

Soham, Eky, CB7 5JD, United Kingdom

Location

Stonehill Medical Centre, Piggot st.

Farnworth BL4 9QZ Bolton, Lancashire, BL4 9QZ, United Kingdom

Location

Stanwell Road Surgery, 25 Stanwell Road

Ashford, Middlesex, TW15 3EA, United Kingdom

Location

The Circle Practice/Belmont Health Centre

Harrow, Middlesex, HA3 7LT, United Kingdom

Location

Woolwell Medical Centre

Devon, Plymouth, PL6 7TH, United Kingdom

Location

The Medical Centre, Kingston ave

East Horsley, Surrey, KT24 6QT, United Kingdom

Location

Albany House Medical Centre, 3 Queen St.

Wellingborough, NN8 4RW, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• W. M. Mulleners

  Canisius-Wilhelmina Zeikenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: May 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 8, 2008

Record last verified: 2008-02

Locations

NL (4); FI (5); GB (10)