Efficacy and Safety Study of Dysport® Used for Migraine P... | NCT00301665

Studies
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

NCT00301665

Sponsor

Ipsen

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

138Actual

Phase

Phase 2

Conditions

Migraine

Interventions

Botulinum toxin type A

Countries

Czechia
Poland
Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

Mar 2005Actual

First Submitted Date

Mar 9, 2006

First Submission Date that Met QC Criteria

Mar 9, 2006

First Posted Date

Mar 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2020

Last Update Posted Date

Apr 24, 2020Actual

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin type A	Biological			AbobotulinumtoxinA (Dysport®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.		3 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction of the intensity of the migraine attacks.		3 months
Reduction of duration of the migraine attacks.		3 months
Reduction of migraine medication consumption.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients having migraine without aura or with typical aura as defined by International Headache Society criteria
Migraine attacks have been persisting for more than 1 year
2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit
2 to 6 migraine attacks of at least moderate severity during the screening period

Exclusion Criteria:

Non-migraine headaches such as tension-type headaches
Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine
Onset of migraine is after age of 50
Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Anne's Faculty Hospital		Brno		65691	Czechia
University Hospital Hradec Kralove

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
C542869	abobotulinumtoxinA

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided