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CompletedNCT01333397Updated Sep 27, 2022Results posted

Safety and Efficacy Study of Dysport RU and Glabellar Lines

A Phase 2 interventional study of Botulinum toxin type A and Botulinum toxin type A in Glabellar Frown Lines, sponsored by Ipsen. Completed at 8 sites in 2 countries. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by Ipsen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study summary

The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.

02

Conditions studied

  • Glabellar Frown Lines
03

In context

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female between 30 - 60 years of age
  • Moderate to severe vertical glabellar lines at maximum frown at baseline

Exclusion criteria

Exclusion Criteria:

  • Silicone injections into the upper face
  • Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or photorejuvenation within the previous 12 months
  • Any planned facial cosmetic surgery during the study period
  • A history of ablative skin resurfacing of the area to be treated during the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
176 participants (actual)

Study arms

  • Experimental
    Dysport RU 20 U

    Biological: Botulinum toxin type A

  • Experimental
    Dysport RU 50 U

    Biological: Botulinum toxin type A

  • Experimental
    Dysport RU 75 U

    Biological: Botulinum toxin type A

  • Active comparator
    Dysport (Azzalure) 50 U

    Biological: Botulinum toxin type A

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • BiologicalBotulinum toxin type A

    I.M. (in the muscle) injection on day 1 (single treatment cycle)

    Also known as: AbobotulinumtoxinA (DysportRU®)

  • BiologicalBotulinum toxin type A

    I.M. on day 1 (single treatment cycle)

    Also known as: AbobotulinumtoxinA (Azzalure®)

  • DrugPlacebo

    I.M. on day 1 (single treatment cycle)

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown

    Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2.

    Time frame: Day 29

Secondary outcomes

  1. Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.

    A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.

    Time frame: Day 29

  2. Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.

    Time frame: Days 8, 15, 57, 85 and 113

  3. Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.

    Time frame: Days 8, 15, 57, 85 and 113

  4. Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.

    Time frame: Days 8, 15, 57, 85 and 113

  5. Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.

    A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.

    Time frame: Days 8, 15, 29, 57, 85 and 113

  6. Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders

    A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.

    Time frame: Day 113

  7. Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment

    A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment

    Time frame: Days 8, 15, 29, 57, 85 and 113

  8. Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment

    A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment.

    Time frame: Days 8, 15, 29, 57, 85 and 113

  9. Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment

    A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.

    Time frame: Days 8, 15, 29, 57, 85 and 113

  10. Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)

    Time frame: Days 8, 15, 29, 57, 85 and 113

  11. Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)

    Time frame: Days 8, 15, 29, 57, 85 and 113

  12. Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)

    Time frame: Days 8, 15, 29, 57, 85 and 113

  13. Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)

    Time frame: Day 29

Other outcomes

  1. Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study

    Treatment Emergent Adverse Event (TEAE)

    Time frame: Up to Day 113 (±3 days)

07

Results

Posted Oct 30, 2015

Participant flow

Study was performed as a multicentre study at eight investigational sites in France and Germany. Date of first enrolment: 30-Mar-2011 and Date of last completed: 27-Sep-2011.

Participant flow — Overall Study
MilestonePlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
Started3536353535
Completed3436353435
Not completed10010
Withdrew: Lost to follow-up10010

Outcome measures

PrimaryPercentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown

Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2.

Time frame:
Day 29
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 U
ILA (N'=34,36,35,33)088.991.487.9
SSA (N'=34,36,35,33)2.991.785.781.8
Statistical analysis
  • Placebo vs Dysport NG 20 U · Chi-squared · p = <0.0001
  • Placebo vs Dysport NG 50 U · Chi-squared · p = <0.0001
  • Placebo vs Dysport NG 75 U · Chi-squared · p = <0.0001
  • Placebo vs Dysport NG 20 U · Chi-squared · p = <0.0001
  • Placebo vs Dysport NG 50 U · Chi-squared · p = <0.0001
  • Placebo vs Dysport NG 75 U · Chi-squared · p = <0.0001
SecondaryPercentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.

A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.

Time frame:
Day 29
Reported as:
Number · percentage of subjects
Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.086.185.781.877.1
SecondaryPercentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
Time frame:
Days 8, 15, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 U
ILA: Day 8 (N'=34,36,35,35)077.880.082.9
ILA: Day 15 (N'=33,36,35,35)3.080.694.391.4
ILA: Day 57 (N'=33,35,34,34)077.179.482.4
ILA: Day 85 (N'=34,33,34,32)048.558.875.0
ILA: Day 113 (N'=34,36,35,34)022.242.955.9
SecondaryPercentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
Time frame:
Days 8, 15, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 U
SSA: Day 8 (N'=34,36,35,35)2.966.765.774.3
SSA: Day 15 (N'=33,36,35,35)3.080.682.980.0
SSA: Day 57 (N'=34,35,34,34)080.067.682.4
SSA: Day 85 (N'=34,35,34,32)057.147.162.5
SSA: Day 113 (N'=34,36,35,34)036.134.352.9
SecondaryPercentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Time frame:
Days 8, 15, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
Day 8 (N'=34,36,35,35,35)061.162.974.351.4
Day 15 (N'=34,36,35,35,34)075.082.980.067.6
Day 57 (N'=34,35,34,34,34)074.367.679.464.7
Day 85 (N'=34,33,34,32,34)042.444.162.538.2
Day 113 (N'=34,36,35,34,35)019.434.341.225.7
SecondaryPercentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.

A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.

Time frame:
Days 8, 15, 29, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 U
ILA: Day 8 (N'=18,17,13,14)11.170.676.971.4
ILA: Day 15 (N'=18,17,13,14)11.170.692.378.6
ILA: Day 29 (N'=18,17,13,14)5.682.476.985.7
ILA: Day 57 (N'=17,16,13,14)11.881.376.978.6
ILA: Day 85 (N'=18,17,12,14)5.682.475.064.3
ILA: Day 113 (N'=18,17,13,14)11.152.953.857.1
SecondaryPercentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders

A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.

Time frame:
Day 113
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
ILA: Day 29 (N'=0,32,32,29,27)025.046.965.540.7
SSA: Day 29 (N'=1,33,30,27,29)036.440.063.034.5
SecondaryPercentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment

A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment

Time frame:
Days 8, 15, 29, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
ILA: Day 8 (N'=34,36,35,35,35)030.645.745.731.4
ILA: Day 15 (N'=33,36,35,35,34)050.062.957.150.0
ILA: Day 29 (N'=34,36,35,33,35)055.668.663.657.1
ILA: Day 57 (N'=33,35,34,34,34)034.347.144.141.2
ILA: Day 85 (N'=34,33,34,32,34)024.229.431.326.5
ILA: Day 113 (N'=34,36,35,34,35)013.914.320.68.6
SecondaryPercentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment

A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment.

Time frame:
Days 8, 15, 29, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
ILA: Day 8 (N'=18,17,13,14,19)5.65.923.121.410.5
ILA: Day 15 (N'=18,17,13,14,18)5.617.623.121.416.7
ILA: Day 29 (N'=18,17,13,14,19)011.823.128.621.1
ILA: Day 57 (N'=17,16,13,14,19)5.918.815.421.415.8
ILA: Day 85 (N'=18,17,12,14,19)017.616.77.115.8
ILA: Day 113 (N'=18,17,13,14,19)05.923.114.35.3
SecondaryPercentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment

A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.

Time frame:
Days 8, 15, 29, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
percentage of subjectsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
SSA: Day 8 (N'=34,36,35,35,35)025.042.940.034.3
SSA: Day 15 (N'=33,36,35,35,34)052.857.154.347.1
SSA: Day 29 (N'=34,36,35,33,35)052.860.057.657.1
SSA: Day 57 (N'=34,35,34,34,34)040.052.944.147.1
SSA: Day 85 (N'=34,35,34,32,34)028.629.431.329.4
SSA: Day 113 (N'=34,36,35,34,35)08.322.911.817.1
Other pre-specifiedNumber of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study

Treatment Emergent Adverse Event (TEAE)

Time frame:
Up to Day 113 (±3 days)
Reported as:
Number · participants
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
participantsPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
TEAE1215101110
Severe TEAE01000
Related TEAE56442
Related and severe TEAE00000
TEAE leading to withdrawal00000
TEAE leading to death00000
Serious Adverse Event (SAE)01000
SecondaryPercentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
Time frame:
Days 8, 15, 29, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
percentage of subjectsDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
ILA: Day 8 (N'=36,35,35,35)77.880.082.957.1
ILA: Day 15 (N'=36,35,35,34)80.694.391.473.5
ILA: Day 29 (N'=36,35,33,35)88.991.487.977.1
ILA: Day 57 (N'=35,34,34,34)77.179.482.470.6
ILA: Day 85 (N'=33,34,32,34)48.558.875.052.9
ILA: Day 113 (N'=36,35,34,35)22.242.955.931.4
SecondaryPercentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
Time frame:
Days 8, 15, 29, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
percentage of subjectsDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
SSA: Day 8 (N'=36,35,35,35)66.765.774.357.1
SSA: Day 15 (N'=36,35,35,34)80.682.980.073.5
SSA: Day 29 (N'=36,35,33,35)91.785.781.882.9
SSA: Day 57 (N'=35,34,34,34)80.067.682.473.5
SSA: Day 85 (N'=35,34,32,34)57.147.162.541.2
SSA: Day 113 (N'=36,35,34,35)36.134.352.928.6
SecondaryPercentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
Time frame:
Days 8, 15, 29, 57, 85 and 113
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
percentage of subjectsDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
ILA: Day 8 (N'=17,13,14,19)70.676.971.463.2
ILA: Day 15 (N'=17,13,14,18)70.692.378.672.2
ILA: Day 29 (N'=17,13,14,19)82.476.985.784.2
ILA: Day 57 (N'=16,13,14,19)81.376.978.684.2
ILA: Day 85 (N'=17,12,14,19)82.475.064.368.4
ILA: Day 113 (N'=17,13,14,19)52.953.857.152.6
SecondaryPercentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)
Time frame:
Day 29
Reported as:
Number · percentage of subjects
Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)
percentage of subjectsPlaceboDysport 50 U
ILA: (N'=34,35)077.1
SSA: (N'=34,35)2.982.9

Adverse events

Collected over Up to Day 113 (±3 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/35 (0%)12/35 (34.3%)
Dysport NG 20 U—1/36 (2.8%)14/36 (38.9%)
Dysport NG 50 U—0/35 (0%)10/35 (28.6%)
Dysport NG 75 U—0/35 (0%)11/35 (31.4%)
Dysport 50 U—0/35 (0%)10/35 (28.6%)
Most frequent serious events
Most frequent serious events
EventPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
VertigoEar and labyrinth disorders0/351/360/350/350/35
HeadacheNervous system disorders0/351/360/350/350/35
Most frequent other events
Showing 10 of 55
Most frequent other events
EventPlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 U
HeadacheNervous system disorders4/352/363/352/353/35
NasopharyngitisInfections and infestations4/350/361/351/352/35
Back painMusculoskeletal and connective tissue disorders0/351/360/350/352/35
Eyelid ptosisEye disorders0/351/360/352/350/35
Road traffic accidentInjury, poisoning and procedural complications2/350/360/351/350/35
Injection site painGeneral disorders1/352/361/352/351/35
MigraineNervous system disorders0/351/361/350/351/35
SyncopeNervous system disorders0/350/361/350/350/35
InfluenzaInfections and infestations0/350/360/350/351/35
GastroenteritisInfections and infestations0/350/360/351/350/35

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 UTotal
Mean46.8 ± 6.446.7 ± 8.448.1 ± 6.947.9 ± 6.047.0 ± 6.647.3 ± 6.9
Sex/Gender, Customized
Sex/Gender, Customized(participants)PlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 UTotal
Female3536353535176
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)PlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 UTotal
Hispanic or Latino020215
Not Hispanic or Latino3534353334171
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)PlaceboDysport NG 20 UDysport NG 50 UDysport NG 75 UDysport 50 UTotal
White3536353535176
08

Study locations

8 sites
  • Private practice
    Bordeaux, France
  • Private practice
    Cannes, France
  • Private practice
    Juan Les Pins, France
  • Private practice
    Paris, France
  • Charité hospital
    Berlin, Germany
  • Private clinic
    Dresden, Germany
  • Private clinic
    Munich, Germany
  • Private clinic
    Starnberg, Germany
09

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01333397
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Apr 12, 2011
Start date
Mar 2011
Primary completion
Sep 2011
Completion
Sep 2011
Results posted
Oct 30, 2015
Last update
Sep 27, 2022

Study contacts

Ipsen Study Director
study director · Ipsen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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