Use Of GW274150 In The Prophylactic Treatment Of Migraine

NCT00242866 | Completed Phase 2

• 1 other identifier: NOS103325
• Study Type: interventional
• Target: 430
• Locations: 9 countries
• Sites: 62

Brief Summary

Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the prevention of migraine headache. GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. The intent of this study is to investigate the safety and efficacy of GW274150 for the prophylactic treatment of migraine headache.

Conditions

Migraine Disorders

Keywords

Productivity; Efficacy; without aura; iNOS; Safety; Nitric Oxide; Pharmacokinetics; GW274150; with aura; Migraine; Prophylaxis; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period.

  12 Weeks

Secondary Outcomes (1)

• Change from baseline in the number of migraine headache days, migraine attacks, mean peak migraine pain severity and mean migraine headache duration for each 4 week treatment period and over the entire treatment period.

  12 Weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

GW274150 - 5mg or 30mg

Drug: GW274150; Other: Placebo

Arm 2

PLACEBO COMPARATOR

Placebo to match GW274150

Drug: GW274150; Other: Placebo

Interventions

GW274150 DRUG

The tablets used in this study will contain either 5mg or 30mg of GW274150

Arm 1; Arm 2

Placebo OTHER

Placebo to Match GW274150

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suffering from migraine with or without aura.
• Migraine for at least one year, and the age of onset was prior to 50 years.
• Consistent migraine headache over time and has had at least 3 migraine headache attacks but less than 15 days with headache (migraine or non-migraine) per month in each of the three months prior to the Screening Visit and maintains this requirement during the baseline period.
• Able to distinguish migraine headache attacks as discreet attacks from other headaches (i.e. tension-type headaches).
• No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the doctor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
• Written informed consent prior to entry into the study.
• Females who are: a) non-childbearing potential or, b) of child-bearing potential, has a negative pregnancy test at screen, and is taken adequate contraceptive measures.

You may not qualify if:

• As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
• Headache for 15 days per month or greater in any of the three months (90 days) preceding the Screening Visit.
• History of alcohol, substance or drug abuse within the last year.
• Taken a migraine prophylactic medication within 1 month of the Screening Visit.
• Uses an opiate as first line acute treatment for migraine attacks.
• History of ergotamine, triptan, opioid, or combination medication intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months.
• History of simple analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months.
• Failed two or more adequate treatments of migraine prophylaxis, where failure is defined as a lack of efficacy with a treatment duration of at least 8 weeks or withdrawal of treatment due to treatment intolerance.
• Uncontrolled hypertension at the Screening Visit, defined as systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg.
• Taking cyclosporine and/or aminoglycosides.
• Evidence of renal impairment - calculated creatinine clearance \<60ml/min or clinically relevant finding on urinalysis.
• History of drug or other allergy which, in the opinion of the doctor, makes the subject unsuitable for participation in the study.
• Concurrently participating in another clinical study or investigational drug trial or has participated within the previous 3 months or is planning to participate in another drug or device study at any time during this study (screening through follow-up) or has had previous exposure to GW274150 in Part 1 of the study.
• Felt to be at risk of non-compliance (for taking study medication or for completing the electronic diary (e-diary)), in the doctor's opinion.
• Pregnant or nursing women.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (62)

GSK Investigational Site

Antwerp, 2018, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Glostrup Municipality, DK-2600, Denmark

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GSK Investigational Site

Odense C, 5000, Denmark

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GSK Investigational Site

Oelstykke, 3650, Denmark

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GSK Investigational Site

Helsinki, 00100, Finland

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GSK Investigational Site

Jyväskylä, 40100, Finland

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GSK Investigational Site

Mikkeli, 50100, Finland

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GSK Investigational Site

Tampere, 33210, Finland

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GSK Investigational Site

Turku, 20100, Finland

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GSK Investigational Site

Anzin, 59410, France

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GSK Investigational Site

Chilly-Mazarin, 91380, France

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GSK Investigational Site

Évreux, 27000, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Luynes, 37230, France

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GSK Investigational Site

Montbrison, 42600, France

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GSK Investigational Site

Toulouse, 31300, France

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GSK Investigational Site

Tours, 37100, France

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GSK Investigational Site

Vieux-Condé, 59690, France

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GSK Investigational Site

Voiron, 38506, France

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GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

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GSK Investigational Site

Hüttenberg, Hesse, 35625, Germany

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GSK Investigational Site

Wiesbaden, Hesse, 65189, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45122, Germany

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GSK Investigational Site

Münster, North Rhine-Westphalia, 48149, Germany

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GSK Investigational Site

Kiel, Schleswig-Holstein, 24149, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10435, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10961, Germany

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GSK Investigational Site

Modena, Emilia-Romagna, 41100, Italy

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GSK Investigational Site

Rome, Lazio, 00163, Italy

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Sestri Ponente (GE), Liguria, 16153, Italy

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GSK Investigational Site

Catania, Sicily, 95124, Italy

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GSK Investigational Site

Florence, Tuscany, 50139, Italy

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GSK Investigational Site

Feltre (BL), Veneto, 32032, Italy

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GSK Investigational Site

Blaricum, 1261 AN, Netherlands

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GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

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GSK Investigational Site

Etten-Leur, 4872 LA, Netherlands

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GSK Investigational Site

Geldermalsen, 4191 AH, Netherlands

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GSK Investigational Site

Grubbenvorst, 5971 BB, Netherlands

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GSK Investigational Site

Heerlen, 6419 PC, Netherlands

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GSK Investigational Site

Hengelo, 7555 DL, Netherlands

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GSK Investigational Site

Hoogwoud, 1718 BG, Netherlands

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GSK Investigational Site

Nijmegen, 6532 SZ, Netherlands

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GSK Investigational Site

Spijkenisse, 3207 NB, Netherlands

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GSK Investigational Site

Venray, 5801 CE, Netherlands

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GSK Investigational Site

Zwolle, 8011 JW, Netherlands

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GSK Investigational Site

Bergen, 5007, Norway

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GSK Investigational Site

Elverum, 2408, Norway

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GSK Investigational Site

Hamar, 2317, Norway

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GSK Investigational Site

Hønefoss, N-3515, Norway

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GSK Investigational Site

Lier, 3400, Norway

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GSK Investigational Site

Oslo, 0277, Norway

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GSK Investigational Site

Sandvika, N-1338, Norway

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GSK Investigational Site

Ávila, 05071, Spain

Location

GSK Investigational Site

Barcelona, 08003, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Oviedo, 33006, Spain

Location

GSK Investigational Site

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

GW 274150

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 21, 2005
• Study Start: October 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 9, 2016

Record last verified: 2015-09

Locations

IT (7); DK (3); ES (6); NO (7); NL (12); FI (5); FR (10); DE (9); BE (3)