Tonabersat in the Prophylaxis of Migraine With Aura

NCT00332007 | Completed Phase 2

• 1 other identifier: TON/02/05-CLIN
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Overall trial objectives:

1. 1.Can treatment with tonabersat reduce the number of days with aura and/or migraine headache in patients with migraine with aura
2. 2.How well tolerated is treatment with tonabersat

Conditions

Migraine With Aura

Outcome Measures

Primary Outcomes (3)

• Difference in the mean number of aura attacks experienced between treatment groups

  12 week treatment period

• Difference in the mean number of migraine headache days between treatment groups

  12 week treatment period

• Incidence of adverse events

  12 week treatment period

Secondary Outcomes (9)

• Mean number of headache days in each treatment period.

  12 week treatment period

• Mean number of auras followed by headache in each treatment period.

  12 week treatment period

• Mean number of headache days in each month of treatment in each treatment period.

  Mean monthly

• Mean number of auras and/or migraine headache during each treatment period.

  12 week treatment period

• Mean number of migraine headache attacks in each treatment period.

  12 week treatment period

Study Arms (2)

1

EXPERIMENTAL

Tonabersat 40 mg daily

Drug: Tonabersat

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tonabersat DRUG

two tablets once daily

1

Placebo DRUG

two tablets once daily

2

Eligibility Criteria

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

You may qualify if:

• Patients with an established history of migraine of at least one year meeting the diagnostic criteria of the International Classification of Headache Disorders - Edition 2 (Appendix 2) and who experience at least one aura a month.
• Male or female patients between 18-65 years of age
• Women of child bearing potential must be using a reliable form of contraception (defined in the protocol) for at least 3 months prior to enrolment and they must have a negative pregnancy test at screening with no intention of becoming pregnant during the study period

You may not qualify if:

• Patients experiencing headache other than migraine or tension headache
• Overuse of acute migraine treatments defined as more than 14 daily doses per month with analgesics or more than 9 daily doses per month of ergots or triptans within the last two months
• Migraine prophylactic treatment within two months prior to entry to the trial
• Patients taking any of the following medications for migraine: beta-blockers, tricyclic antidepressants (during the last 2 months), antiepileptic dugs (during the last 2 months), calcium channel blockers, monoamine oxidase inhibitors, daily NSAIDs, daily paracetamol, high dose magnesium supplements (600mg/day). Parenteral administration of botulinum toxin is also excluded. These drugs are permitted when given for diseases other than migraine provided that, in the opinion of the investigator the dose can be kept constant throughout the trial.
• Patients who, in the opinion of the investigator, have significant cerebrovascular disease e.g. transient ischaemic attacks, stroke
• Patients who, in the opinion of the investigator, have clinically significant cardiovascular disease
• Patients suffering from a current clinical diagnosis of a major depressive disorder or schizophrenia
• Patients with renal dysfunction , defined as a serum creatinine of greater than 125% of the upper limit of normal for their age group
• Patients with hepatic dysfunction defined as a liver function test (AST, ALT, alkaline phosphatase, bilirubin) of greater than twice the upper limit of normal for their age group
• Patients with known alcohol or other substance abuse
• Use of an investigational drug (for any indication) within 30 days or 5 half-lives, whichever is the longer, prior to screening
• Women who are pregnant or breast feeding
• Women of childbearing potential not using a reliable form of contraception
• Patients with any other clinically significant condition which, in the investigators opinion, would render them unsuitable for this study

Sponsors & Collaborators

• Minster Research Ltd: lead
• University of Copenhagen: collaborator

Study Sites (1)

Danish Headache Centre, Department of Neurology, Glostrup Hospital

Copenhagen, Denmark

Location

Related Publications (3)

• International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine (second edition). Cephalalgia 2000; 20:765-86. Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products for the treatment of migraine, CPMP/EWP/788/01/Final. London, 17 December 2003.

  BACKGROUND

• Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products for the treatment of migraine, CPMP/EWP/788/01/Final. London, 17 December 2003.

  BACKGROUND

• Hauge AW, Asghar MS, Schytz HW, Christensen K, Olesen J. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study. Lancet Neurol. 2009 Aug;8(8):718-23. doi: 10.1016/S1474-4422(09)70135-8. Epub 2009 Jun 29.

  PMID: 19570717 RESULT

MeSH Terms

Conditions

Migraine with Aura

Interventions

tonabersat

Condition Hierarchy (Ancestors)

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

Study Officials

• Jes Olesen, MD

  University of Copenhagen, Department of Neurology, Glostrup Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 31, 2009

Record last verified: 2009-08

Locations

DK (1)