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Safety and Efficacy of IncobotulinumtoxinA (Xeomin) in the Treatment of Glabellar Frown Lines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00512135
First received: August 6, 2007
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 subjects with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e., MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.


Condition Intervention Phase
Glabellar Lines
Drug: IncobotulinumtoxinA (Xeomin) (20 units)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Multicenter, Repeat-dose Trial to Investigate the Safety and Efficacy of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • - Safety endpoints - Investigator's assessment - Patient's assessment [ Time Frame: Assessment at days 30 and >84 ] [ Designated as safety issue: Yes ]

Enrollment: 796
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IncobotulinumtoxinA (Xeomin) (20 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; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection
Drug: IncobotulinumtoxinA (Xeomin) (20 units)
Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.
Other Name: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins (20 units)

Detailed Description:

This was a prospective, multicenter, open-label, non-control group design Phase 3 clinical study. Approximately 880 subjects who were to complete former studies in this program (370 subjects from studies MRZ 60201-0520/1 (8) and MRZ 60201-0527/1 (8) as well as approximately 510 subjects from studies MRZ 60201-0724/1 (10) and MRZ 60201-0741/1) (11) were expected to enroll in this study in 26 centers in the United States, Canada and Germany. Subjects with moderate to severe glabellar frown lines at maximum frown who completed participation in one of these four "feeder" studies in the frown line program were eligible to participate in this repeated dose study.

Each subject received a dose of 20 units incobotulinumtoxinA (Xeomin) for i.m. injection on Visit 1 (Day 0 of Cycle 1). Re-injections with 20 U NT 201 could be performed on Day 0 of a subsequent cycle for up to 8 cycles (one cycle ≥ 85 days). Intervals between treatments were at least three months or 12 weeks, i.e., ≥ 85 days. For a new treatment cycle to start, the subject had to request a re-injection. The investigator then had to assess if the glabellar frown lines had relapsed to 'moderate' or 'severe'. In this case, a new injection could be administered. The treatment duration per subject was 24 months and up to eight cycles for subjects enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 and 6 months and up to two cycles for subjects enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1, respectively. Subjects enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 participated at least one year in the study whereas subjects enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1 participated for six months and up to two cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with 'moderate' or 'severe' glabellar frown lines at maximum frown at the beginning of each treatment cycle (as assessed by the investigator according to FWS) , stable medical condition; Completion of one former study in the Merz NT 201 glabellar program

Exclusion:

Patients with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton syndrome) putting the patient at risk, History of Facial Nerve Palsy, Previous treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo rejuvenation) in the glabellar area during the last 12 months, Previous insertion of permanent material in the glabellar area; Planned treatment with Botulinum toxin of any serotype in any body region during the study period, Any other planned facial aesthetic procedure in the glabellar area during the trial period; Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these or scars in the glabellar area, Inability to substantially lessen glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis of eyelid and/or eyebrow; Any infection in the area of the injection sites.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512135

  Show 25 Study Locations
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Principal Investigator: Berthold Rzany, Prof. Dr. med Sc.M. Division of Evidence Based Medicine dEBM, Department of Dermatology, Venerology and Allergology , Charité - University Medicine, Berlin, Germany
Principal Investigator: Timothy Corcoran Flynn, MD
  More Information

Publications:
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00512135     History of Changes
Other Study ID Numbers: MRZ 60201-0609/1
Study First Received: August 6, 2007
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014