Double-blind, Placebo-controlled Study of BGC20-1531 in Migraine

NCT00888680 | Withdrawn Phase 2

• 1 other identifier: BGC20-1531-06
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 4

Brief Summary

The study is being conducted to explore the safety and effectiveness of a new chemical entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at least one week wash out period between doses.

Conditions

Migraine

Keywords

Migraine; Headaches; Migraine headaches; Head pain

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of BGC20-1531 on headache response, defined as a decrease of headache from severe or moderate to mild or none at 2 hours post-dose without the use of rescue medication.

  2 hours

Secondary Outcomes (4)

• To evaluate the effect of BGC20-1531 on pain-freedom up to 48 hours post-dose without the use of rescue medication.

  Up to 48 hours

• To evaluate the effect of BGC20-1531 on headache response up to 48 hours post-dose (without the use of rescue medication).

  Up to 48 hours

• To evaluate the effect of BGC20-1531 on sustained headache relief and pain-freedom over a 24-hour and 48-hour period post-dose.

  Up to 48 hours

• To evaluate the safety of BGC20-1531.

  Duration of the study

Study Arms (3)

BGC20-1531 200 mg

EXPERIMENTAL

Drug: BGC20-1531

BGC20-1531 400mg

EXPERIMENTAL

Drug: BGC20-1531

Lactose

PLACEBO COMPARATOR

Drug: Lactose

Interventions

BGC20-1531 DRUG

BGC20-1531 administered orally

BGC20-1531 200 mg; BGC20-1531 400mg

Lactose DRUG

Placebo administered orally

Lactose

Eligibility Criteria

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

You may qualify if:

• Diagnosis of migraine (with or without aura) according to the criteria of the International Headache Society.
• Age at onset of migraine less than 45.0 years.
• Males and females between 18.0 and 65.0 years of age inclusive.
• Be willing and able to give written informed consent.
• For female patients, a negative pregnancy test
• Sexually active participants and their partners should be using an effective method of contraception; combined hormonal or progestogen-only methods, IUD/IUS, diaphragm/condoms with spermicide or sterilisation.
• History of 1-6 migraine attacks per month (with or without aura) in the 3 months prior to screening, with at least 48 hours freedom from headache between attacks.
• Patients receiving migraine prophylactic treatment can be enrolled, providing they are receiving only one drug for prophylaxis and the prescribed daily dose is not changed in the month prior to screening.
• Rescue medication is permitted in the study.
• Women with menstrual migraine (or who have suspected menstrual migraine or are subsequently diagnosed with menstrual migraine) may be included in the study and instructed to treat each consecutive attack with study medication (unless within the wash-out period).
• Patients who are willing and able to comply with study requirements including completion of the study diary.
• Patients who are taking prescribed medication for depression may be included providing this treatment has been stable for 3 months prior to screening and is expected to remain stable for the duration of the study.

You may not qualify if:

• Patients with ≥15 headache days (migraine and non-migraine headaches combined) per month.
• Patients who take analgesics for any reason ≥15 days a month or triptans ≥10 days a month.
• Non-migraine headaches on more than 6 days per month.
• Patients with schizophrenia.
• Patients prescribed more than one migraine prophylaxis treatment.
• Patients receiving prophylaxis whose prescribed daily dose has changed within the month before screening.
• Patients whose prophylactic treatment is not expected to remain stable for the duration of the study.
• Patients whose prophylactic treatment has been withdrawn within the month prior to study entry.
• Patients taking ergotamine, ergotamine derivatives or ergotamine combination products.
• Any relevant abnormality on history or examination including central nervous system, psychiatric (excluding depression), respiratory, cardiovascular or metabolic dysfunction.
• Abnormal laboratory findings suggesting infectious, endocrine, malignant disease or other systemic disorder; any isolated abnormal laboratory finding considered clinically relevant by the investigator at screening.
• Subjects with clinically significant abnormalities in 12-lead electrocardiogram (ECG), blood pressure and/or pulse at screening.
• Recent or clinically significant history of drug or alcohol abuse.
• Inability to communicate well with the investigator (ie, language problem, poor mental development or impaired cerebral function).
• Participation in a clinical study of an Investigational Medicinal Product (IMP) within the 3 months up to screening.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Danish Headache Center

Glostrup Municipality, Denmark

Location

Head and Neck Research Group

Oslo, Norway

Location

Norwegian National Headache Centre

Trondheim, Norway

Location

The City of London Migraine Clinic

London, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

N-(4-(4-(5-methoxypyridin-2-yl)phenoxymethyl)-5-methylfuran-2-carbonyl)-2-methylbenzenesulfonamide; Lactose

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Messoud Ashina, MD

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 28, 2009
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

DK (1); NO (2); GB (1)