AzTrials
AzTrials

Migraine Without AuraPhase 2NCT00311662

Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache

A Phase 2 study testing Tonabersat in people with Migraine Without Aura and Migraine With Aura, run by Minster Research Ltd at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Overall trial objectives: Can treatment with tonabersat reduce the number of days with a migraine headache in patients who suffer from frequent migraine attacks How well tolerated is treatment with tonabersat The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Migraine Without Aura, Migraine With Aura
What is being tested?
Tonabersat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
17 sitesin 4 countries
Study dates
Apr 2006to Oct 2006
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • An established history of migraine of at least one year, with or without aura, meeting the diagnostic criteria of the International Classification of Headache Disorders, and experience between four and 14 migraine headache days per month; headache days should be experienced within at least two and no more than six migraine attacks per month.
  • Women of child bearing potential must be using a reliable form of contraception (defined in the protocol) for at least three months prior to enrolment with contraception maintained for at least 7 days after the last dose of study medication and they must have a negative pregnancy test at screening with no intention of becoming pregnant during the study period.

Who cannot join

  • Patients with a diagnosis of migraine according to the diagnostic criteria of the International Classification of Headache Disorders at age 50 years or more.
  • Experience frequent non-migraine headache
  • Patients with pure menstrual migraine defined as patients in whom migraine attacks occur exclusively on Day 1 +/- 2 (i.e. Days -2 to +3) of menstruation in at least two out of three menstrual cycles and at no other times of the cycle.
  • Patients with other significant central nervous system disorders in the opinion of the investigator.
  • Failure to respond to more than two adequately dosed (i.e. recommended total daily dose and of sufficient duration) migraine prophylactic medications.
  • Overuse of acute migraine treatments defined as more than 14 medication days per month with analgesics and opioids and nine medication days per month of ergots or triptans.
Show all 17Show fewer
  • Prophylactic treatment within two months prior to entry to the trial.
  • Patients taking any of the following medications: beta-blockers (during the last two months), tricyclic antidepressants (during the last two months), antiepileptic drugs (during the last two months), calcium channel blockers (during the last two months), monoamine oxidase inhibitors (during the last two months), daily oral NSAIDs, daily paracetamol, high dose magnesium supplements (600 mg/day), daily multivitamin preparations containing more than 10 mg riboflavin, daily use of oral corticosteroids and daily herbal preparations (e.g. feverfew, butterwort and St John's Wort). Parenteral administration of Botulinum toxin is also excluded. Patients taking other medications used as prophylaxis for migraine including methysergide, anti spasticity agents (e.g. tizanidine) and the new generation antipsychotics (e.g. olanzapine) currently or within the previous two months should also be excluded.
  • 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 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 (aspartate aminotransferase [AST], alanine aminotransferase [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.
  • Failure to complete the diary card during the baseline period.
  • Participation in another clinical trial in the previous four weeks.
  • Any women who is pregnant, lactating or not using medically acceptable contraception.

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

South Africa10 sites

  • Quinta-Med

    Bloemfontein, Bloemfontein 9301

  • Chris Barnard Memorial Hospital

    Cape Town, West Cape 8001

  • St. Augustine's Medical Mews

    Durban, KZ-Natal 4001

  • Francois Le Clus

    Johannesburg, Gauteng 1619

  • Dr I Engelbrecht

    Lyttleton, Guateng 0157

  • Pretoria East Hospital, Neuro-Orthopaedic Unit

    Pretoria, Gauteng 0044

  • Intercare Corporate Office

    Pretoria, Gauteng 0081

  • Dr J Bouwer

    Pretoria, Gauteng 0082

  • Little Company of Mary, Neurospinal Building

    Pretoria, Gauteng 0181

  • SCION Clinical Research, 316 Medi-Clinic Heart Hospital

    Pretoria, Guateng 0002

Other trials in South Africa

Hungary4 sites

  • Kenézy Gyula County Hospital, Dept of Neurology

    Debrecen, Debrecen 1145

  • Petz Aladár Megyei Oktató Kórház

    Győr, Gyor 9024

  • Borsod Abauj Zemplén Megyei Kórház, Neurologiai Osztaly

    Miskolc, Miskolc 3526

  • Zala County Hospital, Department of Cardiology

    Zalaegerszeg, Zalaegerszeg 8900

Other trials in Hungary

Denmark2 sites

  • Glostrup Amtssygehus, Neurologisk Ambulatorium N01

    Copenhagen, Glostrup 2600

  • Bispebjerg Hospital, Neurolgisk Afdeling N

    Copenhagen, Kobenhavn NV 2400

Other trials in Denmark

United Kingdom1 site

  • The National Hospital for Neurology & Neurosurgery

    London, WC1N 3BG

Other trials in United Kingdom

About this study

Official title: Multi-centre, Parallel Group, Double-blind, Placebo Controlled Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache

Overall trial objectives:

  • Can treatment with tonabersat reduce the number of days with a migraine headache in patients who suffer from frequent migraine attacks
  • How well tolerated is treatment with tonabersat

The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of the early events in the generation of migraine and so be effective as prophylactic treatment

Being tested
Tonabersat, Placebo
Medical subject headings
Migraine without Aura, Migraine with Aura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TonabersatDrug

    Also called SB220453

    Tablet 40mg daily for 12 weeks

  • PlaceboDrug

    Tablet once daily for 12 weeks

Study groups in NCT00311662
Study groupRoleWhat they receive
1ExperimentalTonabersat 40mg
Receives: Drug: Tonabersat
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the mean monthly number of migraine headache days from the baseline period to Month 3.

    Measured: weeks 8 to 12 compared to weeks -4 to 0

  2. Incidence of all adverse events (AEs), serious AEs and AEs leading to withdrawal of trial medication, clinical laboratory tests, vital signs and physical examination

    Measured: 12 weeks

Secondary outcomes (10)

  1. Change in the mean monthly number of migraine headache days from the baseline period to across the whole treatment period.

    Measured: weeks 0-12 compared to weeks -4 to 0

  2. Proportion of patients defined as a responder, i.e. those with a reduction of at least 50% in the mean monthly number of migraine headache days in the third month of treatment and over the whole treatment period.

    Measured: weeks 8-12 compared to weeks -4 to 0

  3. Change in mean monthly number of migraine attacks from the baseline period to Month 3.

    Measured: weeks 8-12 compared to weeks -4 to 0

  4. Change in mean monthly number of migraine attacks from the baseline period to across the whole treatment period.

    Measured: weeks 0 to 12 compared to weeks -4 to 0

  5. Proportion of patients defined as a responder, i.e. those with a reduction of at least 50% in the mean monthly frequency of migraine attacks in the third month of treatment and over the whole treatment period.

    Measured: weeks 8-12 compared to weeks -4 to 0

  6. Speed of effect of treatment.

    Measured: 12 weeks

  7. Change in the mean monthly consumption of rescue medication from the baseline period to Month 3.

    Measured: weeks 8 to 12 compared to weeks -4 to 0

  8. Change in the mean monthly consumption of rescue medication from the baseline period to across the whole treatment period.

    Measured: weeks 0 to 12 comoared to weeks -4 to 0

  9. Overall severity of migraine attacks occurring during the treatment period.

    Measured: 12 weeks

  10. Overall response to the question "How satisfied are you with the trial medication?"

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00311662
Sponsor's protocol ID
TON/01/05-CLIN
Status last verified
Aug 2009
First submitted
4 Apr 2006
Last updated
31 Aug 2009
Results posted
No
Data monitoring committee
No

Publications

  • Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ, Guidetti V, Jones B, Lipton RB, Massiou H, Meinert C, Sandrini G, Steiner T, Winter PB; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000 Nov;20(9):765-86. doi: 10.1046/j.1468-2982.2000.00117.x. No abstract available.

    PubMed 11167908

  • Lauritzen M. Pathophysiology of the migraine aura. The spreading depression theory. Brain. 1994 Feb;117 ( Pt 1):199-210. doi: 10.1093/brain/117.1.199.

    PubMed 7908596

  • 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.

  • Goadsby PJ, Ferrari MD, Csanyi A, Olesen J, Mills JG; Tonabersat TON-01-05 Study Group. Randomized, double-blind, placebo-controlled, proof-of-concept study of the cortical spreading depression inhibiting agent tonabersat in migraine prophylaxis. Cephalalgia. 2009 Jul;29(7):742-50. doi: 10.1111/j.1468-2982.2008.01804.x. Epub 2009 Feb 13.

    PubMed 19222510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tonabersat in people with Migraine Without Aura and Migraine With Aura, run by Minster Research Ltd at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Africa, Hungary, Denmark, United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in the mean monthly number of migraine headache days from the baseline period to Month 3. (time frame: weeks 8 to 12 compared to weeks -4 to 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00311662, which also lists 4 linked publications.

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 31 Aug 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in