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Efficacy of OnabotulinumtoxinA in Migraine

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ClinicalTrials.gov Identifier: NCT04578782
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary:

Population studies estimate that patients who have episodic migraine transition to chronic migraine at a rate of about 2.5% per year.

CM is a devastating disorder associated to severe disability. Patients with CM frequently overuse symptomatic medications in the attempt to control their disease, which adds up to the high costs associated to the disorder In this frame, it seems of the outmost importance to strive at preventing the transition from EM to CM.

At the moment Onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis.

The aim of the present study was to evaluate the efficacy of BoNT-A in reducing the number of migraine days in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.


Condition or disease Intervention/treatment Phase
Migraine Drug: OnabotulinumtoxinA Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study for the Evaluation of the Efficacy of OnabotulinumtoxinA in High Frequency Migraine
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Botox Migraine

Arm Intervention/treatment
Experimental: BOTOX
155 UI of Botox were injected according to the approved PREEMPT protocol (the only FDA-approved injection pattern for chronic migraine), in 31 sites. From visit 5, the PREEMPT 'follow-the-pain' paradigm was applied in patients falling in the 'non-responder' or 'partial responder' classes after the first BoNT-A injection, with the possibility to increase the doses up to 195 UI in maximum 39 sites. The injections were every 3 months for 4 cycles
Drug: OnabotulinumtoxinA
BOTOX contains onabotulinumtoxinA, an acetylcholine release inhibitor and a neuromuscular blocking agent available in the lyophilized form of purified clostridium botulinum toxin type A, suitable for injection, for intramuscular, intradetrusor, or intradermal use. The recommended dilution is 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL. The recommended dose for treating chronic migraine is 155 Units administered intramuscularly using a sterile 30-gauge, needle as 0.1 mL (5 Units) injections per each site.
Other Name: BonT-A (Botox®)




Primary Outcome Measures :
  1. Migraine days/month [ Time Frame: In the last 16 weeks of the study period as compared to the 4 baseline weeks. ]

    To evaluate the efficacy of BoNT-A in reducing the number of migraine days in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

    Based on the response in terms of percent reduction of migraine days from baseline, the following classes will be identified:

    • non-responders: reduction < 30%;
    • partial responders: reduction ranging from 30 to 49%;
    • responders: reduction ranging from 50% to 74%;
    • optimal responders: reduction >75%.


Secondary Outcome Measures :
  1. Monthly headache days [ Time Frame: In the last 16 weeks of the study period as compared to the 4 baseline weeks. ]
    To evaluate the efficacy of BoNT-A in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

  2. Migraine attack intensity [ Time Frame: In the last 16 weeks of the study period as compared to the 4 baseline weeks. ]
    To evaluate the efficacy of BoNT-A in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

  3. Monthly use of acute drugs [ Time Frame: In the last 16 weeks of the study period as compared to the 4 baseline weeks. ]
    To evaluate the efficacy of BoNT-A in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

  4. Migraine Disability Assessment Score Questionnaire (MIDAS) [ Time Frame: In the last 16 weeks of the study period as compared to the 4 baseline weeks. ]

    To evaluate disability in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

    The MIDAS questionnaire is a 7-item questionnaire (with 5 scored items) designed to measure headache-related disability, to improve physician-patient communication, and to identify patients with high treatment needs. Higher values are worse outcomes.


  5. Mental Status Questionnaire (MSQ) [ Time Frame: In the last 16 weeks of the study period as compared to the 4 baseline weeks. ]

    To evaluate the quality of life in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

    The MSQ is a 10-item questionnaire, which provides a brief, objective, and quantitative measurement of cognitive functioning of elderly people.


  6. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: In the last 16 weeks of the study period as compared to the 4 baseline weeks. ]

    To evaluate levels of anxiety and depression in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

    The HADS is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3, with three denoting highest anxiety or depression level.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects fulfilling the diagnostic criteria for migraine without or with aura of the International Headache Classification with a number of migraine days ranging from 9 to 14 days/month in the previous 3 months.
  • The frequency needs to be confirmed over the 28 days before the screening visit .
  • Subjects have to be in general good health, as confirmed by medical history, baseline physical examination, baseline neurological exam and vital signs.
  • Females have to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.

Exclusion Criteria:

  • Previous failure of more than two adequate trials of medications from different drug classes used for migraine prophylaxis;
  • Onset of migraine after age 50;
  • Exclusively migraine aura without headache;
  • Diagnosis of other primary or secondary headache disorders. Episodic tension-tyep headache is allowed if the patient can distinguish clearly between attack of migraine and of tension-type headache;
  • Another chronic painful condition (e.g. osteoarthritis, low back pain);
  • A significant medical history or medical condition of neurological, cardiovascular hepatic or renal disease;
  • History of suicide attempt or suicidal ideation or of a major psychiatric disorder;
  • History of drug or alcohol abuse within the past two years.
  • Known hypersensitivity to botulinum toxin type A or to any of the other ingredients used to form 'Botox®'

Withdrawal criteria

• Severe side effects, diary completion insufficient for evaluation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578782


Locations
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Italy
Headache Science Center
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
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Principal Investigator: Cristina Tassorelli, MD Headache Science Center
Publications:

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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT04578782    
Other Study ID Numbers: FM-BOEM
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
Migraine
OnabotulinumtoxinA
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents