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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Ariston Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ariston Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00285402
First received: January 31, 2006
Last updated: February 6, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Migraine
Migraine Headache
Migraine Disorders
Migraine With Aura
Migraine Without Aura
Drug: AST-726 Low dose
Drug: AST-726 High dose
Drug: AST-726 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study

Resource links provided by NLM:


Further study details as provided by Ariston Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1 Number of subjects that respond with at least a 50% decrease in migraine days in each given 4-week Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 2 The number of migraine headache attacks in each treatment period [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: May 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: AST-726 Low dose
Experimental: B Drug: AST-726 High dose
Placebo Comparator: C Drug: AST-726 Placebo

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

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285402

Locations
Finland
Mediwest Research Centre Oy
Koskenalantie 16, Seinajoki, Finland, 60220
Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)
Brahenkatu 11D, Turku, Turku, Finland, 20100
Suomen Terveystalo Jyvaskyla
Jyvaskyla, Vainonkatu 30, Finland, 40100
Headache Center, Tammertutka
Hameenkatu 18 6th Floor, Tampere, Finland, 33200
Porin Laakerikeskus
Itsenalsyydenk. 33, Pori, Finland, 28100
Netherlands
Isala Kliniek
Groot Wezenland 20, Zwolle, Netherlands, 8000
Ziekenhuisgroep Twente, Afdeling Neurolgie , Locatie Streekziekenhuis Midden Twente
Geerdinksweg 141, Hengelo, Netherlands, 7555
St Anna Hospital, Bogardeind 2
Geldrop, Netherlands, 5664
Canisius Wilhelmina Hospital, Afdeling C02.04
Weg door Jonkerbos 100 SZ Nimegen, Netherlands, 6532
United Kingdom
The Fowey River Practice; Rawlings Lane
Fowey, Cornwall, United Kingdom, PL23 1DT
The Alverton Practice, 7 Alverton Terrace
Penzance, Cornwall, United Kingdom, TR18 4JH
Saltash Health Centre
Saltash, Cornwall, United Kingdom, PL 12 6DI
The Staploe Medical Centre
Soham, Eky, United Kingdom, CB7 5JD
Stonehill Medical Centre, Piggot st.
Farnworth BL4 9QZ Bolton, Lancashire, United Kingdom, BL4 9QZ
Stanwell Road Surgery, 25 Stanwell Road
Ashford, Middlesex, United Kingdom, TW15 3EA
The Circle Practice/Belmont Health Centre
Harrow, Middlesex, United Kingdom, HA3 7LT
Woolwell Medical Centre
Devon, Plymouth, United Kingdom, PL6 7TH
The Medical Centre, Kingston ave
East Horsley, Surrey, United Kingdom, KT24 6QT
Albany House Medical Centre, 3 Queen St.
Wellingborough, United Kingdom, NN8 4RW
Sponsors and Collaborators
Ariston Pharmaceuticals, Inc.
Investigators
Principal Investigator: W. M. Mulleners Canisius-Wilhelmina Zeikenhuis
  More Information

No publications provided

Responsible Party: John A. McLane, Ariston Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00285402     History of Changes
Other Study ID Numbers: ARPH-Cl-03, Eudract no: 2005-003349-15
Study First Received: January 31, 2006
Last Updated: February 6, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Ariston Pharmaceuticals, Inc.:
Migraine
Migraine prophylaxis
Migraine prevention
Chronic migraine treatment

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014