Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

This study has been completed.

Study NCT00288509 Information provided by Ipsen

First Received on February 7, 2006. Last Updated on June 17, 2010 History of Changes

Results First Received: January 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Cervical Dystonia
Intervention:	Drug: abobotulinumtoxinA (Dysport) 250-1000 units

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who completed study NCT00257660 (Y-47-52120-051)were recruited in 15 centres in US and 4 centres in Russia from February 2006 to January 2008 to participate in this study NCT00288509 (Y-47-52120-731).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 116 subjects treated in study NCT00257660, 108 subjects enrolled in this extension study NCT00288509 (Y-47-52120-731). Eight subjects completed study NCT00257660 but elected not to enroll in this extension study.

Reporting Groups

	Description
Dysport	250-1000 units

Participant Flow for 4 periods

Period 1: Treatment Cycle 1

	Dysport
STARTED	108
COMPLETED	102
NOT COMPLETED	6
Adverse Event	1
Lack of Efficacy	1
Withdrawal by Subject	1
Lost to Follow-up	2
Treatment stopped according to protocol	1

Period 2: Treatment Cycle 2

	Dysport
STARTED	100 ^[1]
COMPLETED	97
NOT COMPLETED	3
Lack of Efficacy	1
Withdrawal by Subject	2

[1]	2 subjects completed Cycle 1 but withdrew before Cycle 2 due to insufficient clinical response

Period 3: Treatment Cycle 3

	Dysport
STARTED	96 ^[1]
COMPLETED	91
NOT COMPLETED	5
Lack of Efficacy	1
Withdrawal by Subject	1
Lost to Follow-up	2
Treatment stopped according to protocol	1

[1]	One subject completed Cycle 2 but withdrew before Cycle 3 due to insufficient clinical response

Period 4: Treatment Cycle 4

	Dysport
STARTED	88 ^[1]
COMPLETED	80
NOT COMPLETED	8
Withdrawal by Subject	3
Physician Decision	4
Treatment stopped according to protocol	1

[1]	3 subjects completed Cycle 3 but withdrew before Cycle 4, treatment stopped according to protocol

Baseline Characteristics

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Reporting Groups

	Description
Dysport	250-1000 units

Baseline Measures

	Dysport
Number of Participants [units: participants]	108
Age [units: participants]
<=18 years	0
Between 18 and 65 years	89
>=65 years	19
Age [units: years] Mean ± Standard Deviation	53.5 ± 13.0
Gender [units: participants]
Female	67
Male	41
Region of Enrollment [units: participants]
United States	81
Russian Federation	27

Outcome Measures

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1. Primary:

Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline [ Time Frame: Week 4 follow-up visit ]

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2. Secondary:

Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]

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3. Secondary:

Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]

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4. Secondary:

Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A publication of results from all sites in this multicenter study is expected. If the sponsor no longer plans this or 6 months after study completion at all sites, the PI may publish the results. He will supply any proposed publication to the sponsor for review and comment at least 30 days before submission for publication. If the sponsor believes a patent application should be filed, the publication will be delayed for another 60 days or until patent filing; with a maximum delay of 90 days.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Senior Director, Medical Development, Neurology
Organization: Ipsen
e-mail: clinical.trials@ipsen.com

Publications of Results:

Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. Epub 2010 Mar 31.

Responsible Party:	Jean-Loic Robin, Ipsen
ClinicalTrials.gov Identifier:	NCT00288509 History of Changes
Other Study ID Numbers:	Y-47-52120-731
Study First Received:	February 7, 2006
Results First Received:	January 6, 2010
Last Updated:	June 17, 2010
Health Authority:	United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation