MigrainePhase 2NCT00285402
Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine
A Phase 2 study testing AST-726 Low dose and AST-726 High dose in people with Migraine and Migraine Headache, run by Ariston Pharmaceuticals, Inc. at 19 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Migraine, Migraine Headache, Migraine Disorders
- What is being tested?
- AST-726 Low dose and AST-726 High dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 19 sitesin 3 countries
- Study dates
- May 2007to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- 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.
Additional inclusion criteria in protocol
Primary Exclusion Criteria:
- 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.
Additional exclusion criteria in protocol
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United Kingdom10 sites
Stanwell Road Surgery, 25 Stanwell Road
Ashford, Middlesex, TW15 3EA
Woolwell Medical Centre
Devon, Plymouth, PL6 7TH
The Medical Centre, Kingston ave
East Horsley, Surrey, KT24 6QT
Stonehill Medical Centre, Piggot st.
Farnworth BL4 9QZ Bolton, Lancashire, BL4 9QZ
The Fowey River Practice; Rawlings Lane
Fowey, Cornwall, PL23 1DT
The Circle Practice/Belmont Health Centre
Harrow, Middlesex, HA3 7LT
The Alverton Practice, 7 Alverton Terrace
Penzance, Cornwall, TR18 4JH
Saltash Health Centre
Saltash, Cornwall, PL 12 6DI
The Staploe Medical Centre
Soham, Eky, CB7 5JD
Albany House Medical Centre, 3 Queen St.
Wellingborough, NN8 4RW
Finland5 sites
Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)
Brahenkatu 11D, Turku, Turku, 20100
Headache Center, Tammertutka
Hameenkatu 18 6th Floor, Tampere, 33200
Porin Laakerikeskus
Itsenalsyydenk. 33, Pori, 28100
Suomen Terveystalo Jyvaskyla
Jyväskylä, Vainonkatu 30, 40100
Mediwest Research Centre Oy
Koskenalantie 16, Seinajoki, 60220
Netherlands4 sites
Ziekenhuisgroep Twente, Afdeling Neurolgie , Locatie Streekziekenhuis Midden Twente
Geerdinksweg 141, Hengelo, 7555
St Anna Hospital, Bogardeind 2
Geldrop, 5664
Isala Kliniek
Groot Wezenland 20, Zwolle, 8000
Canisius Wilhelmina Hospital, Afdeling C02.04
Weg Door Jonkerbos 100 SZ Nimegen, 6532
About this study
Official title: Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study
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.
Read the 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
- Being tested
- AST-726 Low dose, AST-726 High dose, AST-726 Placebo
- Keywords
- Migraine, Migraine prophylaxis, Migraine prevention, Chronic migraine treatment
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-726 Low doseDrug
AST-726 High doseDrug
AST-726 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: AST-726 Low dose |
| B | Experimental | Not described Receives: Drug: AST-726 High dose |
| C | Placebo comparator | Not described Receives: Drug: AST-726 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 weeks
2 The number of migraine headache attacks in each treatment period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startMay 2007
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariston Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- W. M. Mulleners, Principal investigator, Canisius-Wilhelmina Zeikenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285402
- Sponsor's protocol ID
- ARPH-Cl-03
- Other IDs
- Eudract no: 2005-003349-15
- Status last verified
- Feb 2008
- First submitted
- 31 Jan 2006
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT00285402
- Acronym / sponsor ID
- ARPH-Cl-03
- Conditions
- Migraine, Migraine Headache, Migraine Disorders, Migraine With Aura, Migraine Without Aura
- Keywords
- Migraine, Migraine prophylaxis, Migraine prevention, Chronic migraine treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Ariston Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 2 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AST-726 Low dose |
| B | Experimental | Drug: AST-726 High dose |
| C | Placebo comparator | Drug: AST-726 Placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-726 Low dose | Drug | A |
| AST-726 High dose | Drug | B |
| AST-726 Placebo | Drug | C |
Primary outcome
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
2 secondary outcomes
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
2 The number of migraine headache attacks in each treatment period
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. M. Mulleners principal investigator
Canisius-Wilhelmina Zeikenhuis
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AST-726 Low dose and AST-726 High dose in people with Migraine and Migraine Headache, run by Ariston Pharmaceuticals, Inc. at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, Finland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2008.