IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merz Pharmaceuticals GmbH

ClinicalTrials.gov Identifier:

NCT00407030

First received: November 30, 2006

Last updated: August 19, 2011

Last verified: August 2011

History of Changes

Results First Received: August 31, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Cervical Dystonia
Interventions:	Drug: incobotulinumtoxinA (Xeomin) (240 Units) Drug: incobotulinumtoxinA (Xeomin) (120 Units) Drug: Placebo

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin) (120 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo	Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection

Participant Flow for 2 periods

Period 1: Main Period - 8 to 20 Weeks

	incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin) (120 Units)	Placebo
STARTED	81	78	74
COMPLETED	76	75	68
NOT COMPLETED	5	3	6
Adverse Event	2	1	0
Lack of Efficacy	0	0	3
Lost to Follow-up	1	1	1
Consent Withdrawn	1	1	1
Withdrawal Criteria Occurred	0	0	1
Patient Decision	1	0	0

Period 2: Extension Period - up to 68 Weeks

	incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin) (120 Units)	Placebo
STARTED	111 ^[1]	103 ^[1]	0 ^[2]
COMPLETED	84	74	0
NOT COMPLETED	27	29	0
Withdrawal Criteria Occurred	4	5	0
Lack of Efficacy	11	11	0
Adverse Event	1	0	0
Consent Withdrawn	4	4	0
Lost to Follow-up	5	5	0
Patient Decision	1	2	0
Physician Decision	1	2	0

[1]	2 subjects did not enter the Ext. Period, 3 subjects never expressed any need for a new injection
[2]	After the Main Period all patients were randomly assigned to the 2 active treatment arms.

Baseline Characteristics

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Reporting Groups

	Description
incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin) (120 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo	Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Total	Total of all reporting groups

Baseline Measures

	incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin) (120 Units)	Placebo	Total
Number of Participants [units: participants]	81	78	74	233
Age [units: years] Mean ± Standard Deviation	53.2 ± 12.2	52.8 ± 11.5	52.4 ± 10.8	52.8 ± 11.5
Gender [units: participants]
Female	54	51	49	154
Male	27	27	25	79

Outcome Measures

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1. Primary:

Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo [ Time Frame: Baseline, week 4 ]

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2. Primary:

Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo [ Time Frame: Baseline, week 4 ]

Show Outcome Measure 2

3. Primary:

Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) [ Time Frame: Baseline, week 4 ]

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4. Secondary:

Change From Baseline in the TWSTRS-Total Score [ Time Frame: Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period) ]

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5. Secondary:

Change From Baseline in the TWSTRS Disability Subscore [ Time Frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) ]

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6. Secondary:

Change From Baseline in the TWSTRS Severity Subscore [ Time Frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) ]

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7. Secondary:

Change From Baseline in the TWSTRS Pain Subscore [ Time Frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) ]

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8. Secondary:

Patient Evaluation of Global Response (PEGR) at Final Visit [ Time Frame: Final visit (up to 20 weeks after injection of the Main Period) ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
Additional Description	The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin) (120 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo	Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection

Other Adverse Events

	incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin) (120 Units)	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	27/81	26/78	14/74
Gastrointestinal disorders
Dysphagia ^{† 1}
# participants affected / at risk	15/81 (18.52%)	9/78 (11.54%)	2/74 (2.70%)
# events	17	10	2
General disorders
Injection site pain ^{† 1}
# participants affected / at risk	3/81 (3.70%)	7/78 (8.97%)	4/74 (5.41%)
# events	3	7	5
Infections and infestations
Nasopharyngitis ^{† 1}
# participants affected / at risk	0/81 (0.00%)	3/78 (3.85%)	5/74 (6.76%)
# events	0	3	5
Musculoskeletal and connective tissue disorders
Muscular weakness ^{† 1}
# participants affected / at risk	9/81 (11.11%)	5/78 (6.41%)	1/74 (1.35%)
# events	12	5	1
Musculosceletal pain ^{† 1}
# participants affected / at risk	3/81 (3.70%)	6/78 (7.69%)	1/74 (1.35%)
# events	4	8	1
Neck pain ^{† 1}
# participants affected / at risk	12/81 (14.81%)	4/78 (5.13%)	3/74 (4.05%)
# events	13	7	3

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (9.1)

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: No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 weeks before submission. Sponsor to give written opinion within 30 days. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.

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: Angelika Hanschmann
Organization: Merz Pharmaceuticals GmbH
phone: ++49-69-1503 ext 538
e-mail: angelika.hanschmann@merz.de

Publications of Results:

Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; on behalf of the U.S. XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(®), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011 Sep 15;308(1-2):103-109. Epub 2011 Jul 18.

Responsible Party:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00407030 History of Changes
Other Study ID Numbers:	MRZ 60201-0408
Study First Received:	November 30, 2006
Results First Received:	August 31, 2010
Last Updated:	August 19, 2011
Health Authority:	United States: Food and Drug Administration

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