Strategy to Adapt Botulinum Toxin Doses in Dystonia | NCT06386848

Studies
Strategy to Adapt Botulinum Toxin Doses in Dystonia

NCT06386848

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Apr 26, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Dystonia

Interventions

Botulinum toxin

Countries

Not provided

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Estimated

Primary Completion Date

May 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Jan 18, 2024

First Submission Date that Met QC Criteria

Apr 24, 2024

First Posted Date

Apr 26, 2024Actual

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 24, 2024

Last Update Posted Date

Apr 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Solène FRISMAND, Dr Kryllof-Frismand Solène, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended.

We we ll study the increase of the dose injected over the time, the side effects...

The hypothesis is that we inject smaller doses than we could regarding the recommandations

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin	Drug	Botulinum toxin doses injected in dystonia		onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First dose of botulinum toxin injected, U	dose injected in U	30 years

Secondary Outcomes

Measure	Description	Time Frame
Effective dose of botulinum toxin	dose injected in U	30 years
Side effects	diplopia, ptosis and others	30 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients over 18 years old followed for dystonia and treated with botulinum toxin

Exclusion Criteria:

first dose of botulinum toxin not available

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 18 years diagnosed with dystonia

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D004421	Dystonia

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001905	Botulinum Toxins
D019274	Botulinum Toxins, Type A
C542869	abobotulinumtoxinA
C545476	incobotulinumtoxinA

Ancestor Terms

ID	Term
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided