Study on Botulinum Toxin Type A for Preventing Chronic Migraine in Adults

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What is this study about?

This clinical trial is focused on studying the prevention of chronic migraine in adults. Chronic migraine is a condition characterized by frequent and severe headache episodes. The treatment being tested in this study is called Dysport, which contains an active ingredient known as Botulinum Toxin Type A. This substance is commonly used in various medical treatments and is administered as an injection.

The purpose of the study is to evaluate how effective and safe Dysport is in reducing the number of migraine days each month for those who suffer from chronic migraines. Participants in the study will receive either Dysport or a placebo, which is a substance with no active medication. The study will follow participants over a period of time to observe changes in their migraine patterns and any side effects they may experience.

Throughout the study, participants will receive regular injections and will be monitored for any changes in their migraine frequency and severity. The study aims to provide valuable information on whether Dysport can help reduce the burden of chronic migraines and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the participant is required to sign informed consent and privacy documentation.

Eligibility is confirmed based on criteria such as age, diagnosis of chronic migraine, and baseline headache and migraine days.

2 randomization and initial assessment

Participants are randomly assigned to receive either Dysport or a placebo.

Initial assessments are conducted to establish baseline data, including the number of monthly migraine days (MMD) and monthly headache days (MHD).

3 treatment phase

Participants receive injections of either Botulinum Toxin Type A (300 or 500 units) or a placebo.

Injections are administered as a solution for injection at specified intervals.

4 monitoring and follow-up

Participants are monitored for changes in MMD and MHD every four weeks, from Week 4 to Week 24.

Additional assessments include the use of acute migraine medication and any treatment-emergent adverse events.

5 evaluation of outcomes

Primary and secondary outcomes are evaluated, including changes in MMD and MHD, and the impact on quality of life.

The study aims to determine the efficacy of Dysport in reducing migraine days compared to placebo.

6 extension phase

Participants may enter an extension phase to further evaluate the long-term effects and safety of the treatment.

Continued monitoring and assessments are conducted during this phase.

Who Can Join the Study?

Participant must be at least 18 years old at the time of signing the informed consent and privacy/data protection documents.
Participant has been diagnosed with chronic migraine for more than 12 months before the screening visit. Chronic migraine is a type of headache disorder.
The participant’s migraines started before they were 50 years old.
Participant has at least 15 headache days per month and at least 8 migraine days per month, based on data collected using an electronic diary during the 4 weeks before the start of the study.
Participant has at least 22 valid diary days recorded during the 4 weeks before the start of the study.

Who Cannot Join the Study?

Participants who do not have chronic migraine. Chronic migraine means having headaches on 15 or more days each month, with at least 8 of those days being migraines.
Participants who are not adults. This study is for adults only.
Participants who are not within the specified age range for the study.
Participants who are part of a vulnerable population. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Futuremeds Sp. z o.o.	Wroclaw	Poland
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Universitaetsmedizin Greifswald KöR	Greifswald	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Irccs San Raffaele Roma S.r.l.	Rome	Italy
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
FutureMeds GmbH	Berlin	Germany
Pratia Brno s.r.o.	Brno-Stred	Czechia
NeuropsychiatrieHK s.r.o.	Prazske Predmesti	Czechia
curiositas ad sanum Studien und Beratungs GmbH	Haag in Obb	Germany
Hospital Clinico Universitario De Valencia	Valencia	Spain
Nemocnice Jihlava prispevkova organizace	Jihlava	Czechia
Neurologie Brno s.r.o.	Brno	Czechia
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Pratia S.A.	Skorzewo	Poland
Hospital Ruber Juan Bravo	Madrid	Spain
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Charite Research Organisation GmbH	Berlin	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
INEP medical s.r.o.	Prague	Czechia
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Vitos Orthopaedische Klinik Kassel gGmbH	Kassel	Germany
Fakultni Thomayerova nemocnice	Prague	Czechia
University Hospital Ostrava	Ostrava	Czechia
Hclujzcd Ugptqopykulpt Rwowiant Ds Mefikm	Malaga	Spain
Akmixri Uezzg Szsrvkqtk Lpcxgi Dl Btqkibd	Bologna	Italy
Dacl Meulaqn stopdz	Prague	Czechia
Aczd Cvkohici skyofh	Prague	Czechia
Splfxoz Poyewk Sfo z oevm	Gdynia	Poland
Kjwwvann dtd Uvbfpzysttym Mlxhrruc Azb	Munich	Germany
Iabxdssq Zdfzukz Dd Bayqoxqwogfaegexo	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	27.10.2023
Germany	Not recruiting	27.10.2023
Italy	Not recruiting	27.10.2023
Poland	Not recruiting	27.10.2023
Spain	Not recruiting	27.10.2023

Trial locations

Investigated drugs:

Botulinum Toxin Type A – Haemagglutinin Complex

Dysport is a medication used in this clinical trial to help prevent chronic migraines in adults. It is being tested to see how effective it is in reducing the number of migraine days each month. Dysport is administered to participants to assess its safety and how well it works compared to not receiving any active treatment.

Chronic Migraine – Chronic migraine is a neurological condition characterized by experiencing headaches on 15 or more days per month, with at least 8 of those days involving migraines. These migraines are often accompanied by symptoms such as nausea, vomiting, and sensitivity to light or sound. The condition can significantly impact daily life, leading to difficulties in work, social activities, and overall quality of life. Over time, the frequency and severity of migraine attacks may increase, making management challenging. Chronic migraine can develop from episodic migraines, where the frequency of attacks gradually rises. The exact cause of chronic migraine is not fully understood, but it is believed to involve a combination of genetic, environmental, and neurological factors.

Trial ID:

2023-504827-17-00

Protocol code:

CLIN-52120-463

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Botulinum Toxin Type A for Preventing Chronic Migraine in Adults

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