Trial Outcomes & Findings for Study Comparing Treatment With Alluzience vs Reconstituted Toxin (NCT NCT05277337)
NCT ID: NCT05277337
Last Updated: 2024-02-16
Results Overview
Time to prepare Alluzience and powder Bont A according to protocol was reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
Baseline (Day 0)
Results posted on
2024-02-16
Participant Flow
The study was conducted at 9 centers in Germany and United kingdom from 04 February 2022 to 12 October 2022.
A total 153 participants were screened, of which 150 participants were randomized and enrolled, 99 participants in the Alluzience treatment group (Group 1) and 51 in the vacuum-dried botulinum neurotoxin type A (Powder BoNT-A) treatment group (Group 2).
Participant milestones
| Measure |
Group 1 (Alluzience)
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
51
|
|
Overall Study
COMPLETED
|
96
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (Alluzience)
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study Comparing Treatment With Alluzience vs Reconstituted Toxin
Baseline characteristics by cohort
| Measure |
Group 1 (Alluzience)
n=99 Participants
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
n=51 Participants
Injection Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 10.91 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
94 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Population: The full analysis set (FAS) population included all randomized and treated participants.
Time to prepare Alluzience and powder Bont A according to protocol was reported.
Outcome measures
| Measure |
Group 1 (Alluzience)
n=99 Participants
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
n=51 Participants
Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
|---|---|---|
|
Time Needed to Prepare Alluzience and Powder BoNT A
|
0.55 Minutes
Standard Deviation 0.414
|
1.57 Minutes
Standard Deviation 0.831
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Population: The full analysis set (FAS) population included all randomized and treated participants.
Percentage of participants injected with Alluzience for whom investigator did not face technical issue/problems when using a ready-to-use product as compared to a product to be reconstituted, assessed using answers within each answer option (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree) was reported.
Outcome measures
| Measure |
Group 1 (Alluzience)
n=99 Participants
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
|---|---|---|
|
Percentage of Participants Injected With Alluzience for Whom Investigator Did Not Face Technical Issue/Problems When Using a Ready-to-use Product as Compared to a Product to be Reconstituted
Strongly Agree
|
91.9 percentage of participants
|
—
|
|
Percentage of Participants Injected With Alluzience for Whom Investigator Did Not Face Technical Issue/Problems When Using a Ready-to-use Product as Compared to a Product to be Reconstituted
Agree
|
8.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Population: The full analysis set (FAS) population included all randomized and treated participants.
Percentage of participants injected with Powder Bont-A for whom investigator experienced issues while reconstitution was assessed using a questionnaire (Yes/No). Percentage of participants with answer "Yes" was reported.
Outcome measures
| Measure |
Group 1 (Alluzience)
n=51 Participants
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
|---|---|---|
|
Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution
|
2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Population: The full analysis set (FAS) population included all randomized and treated participants.
Treating investigators who injected participant with Alluzience answered questions 1 through 12 of the investigator treatment questionnaire for each participant at baseline. The options for each question were strongly agree, agree, neither agree nor disagree, disagree and strongly disagree.
Outcome measures
| Measure |
Group 1 (Alluzience)
n=99 Participants
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
|---|---|---|
|
Investigator Treatment Session Questionnaire
Prefer to utilize ready-to-use product than reconstituted product · Strongly Agree/Agree
|
80 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Prefer to utilize ready-to-use product than reconstituted product · Neither Agree nor Disagree
|
19 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Prefer to utilize ready-to-use product than reconstituted product · Disagree/Strongly disagree
|
0 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Gave more time to explain treatment procedure using ready-to-use product than reconstituted product · Strongly Agree/Agree
|
96 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Gave more time to explain treatment procedure using ready-to-use product than reconstituted product · Neither Agree nor Disagree
|
2 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Gave more time to explain treatment procedure using ready-to-use product than reconstituted product · Disagree/Strongly disagree
|
1 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Could save time on the reconstitution and injection procedure to do something else · Strongly Agree/Agree
|
92 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Could save time on the reconstitution and injection procedure to do something else · Neither Agree nor Disagree
|
7 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Could save time on the reconstitution and injection procedure to do something else · Disagree/Strongly disagree
|
0 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Felt more relaxed/less stressed in not having to reconstitute the product to be injected · Strongly Agree/Agree
|
68 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Felt more relaxed/less stressed in not having to reconstitute the product to be injected · Neither Agree nor Disagree
|
24 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Felt more relaxed/less stressed in not having to reconstitute the product to be injected · Disagree/Strongly disagree
|
7 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Feel more secure with pre-diluted solution and don't have to reconstitute the product myself · Strongly Agree/Agree
|
64 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Feel more secure with pre-diluted solution and don't have to reconstitute the product myself · Neither Agree nor Disagree
|
25 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Feel more secure with pre-diluted solution and don't have to reconstitute the product myself · Disagree/Strongly disagree
|
10 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Have a good feeling about injecting a modern and innovative product than reconstituted product · Strongly Agree/Agree
|
81 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Have a good feeling about injecting a modern and innovative product than reconstituted product · Neither Agree nor Disagree
|
17 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Have a good feeling about injecting a modern and innovative product than reconstituted product · Disagree/Strongly disagree
|
1 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
More precise in my injection with a ready-to-use product than reconstituted product · Strongly Agree/Agree
|
75 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
More precise in my injection with a ready-to-use product than reconstituted product · Neither Agree nor Disagree
|
12 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
More precise in my injection with a ready-to-use product than reconstituted product · Disagree/Strongly disagree
|
12 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Like to propose new innovative treatment with liquid ready-to-use product to my patient · Strongly Agree/Agree
|
86 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Like to propose new innovative treatment with liquid ready-to-use product to my patient · Neither Agree nor Disagree
|
11 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Like to propose new innovative treatment with liquid ready-to-use product to my patient · Disagree/Strongly disagree
|
2 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Produced less waste of non-toxin material using ready-to-use product than reconstituted product · Strongly Agree/Agree
|
96 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Produced less waste of non-toxin material using ready-to-use product than reconstituted product · Neither Agree nor Disagree
|
3 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Produced less waste of non-toxin material using ready-to-use product than reconstituted product · Disagree/Strongly disagree
|
0 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
When I use a ready-to-use toxin I spend less materials for injection · Strongly Agree/Agree
|
98 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
When I use a ready-to-use toxin I spend less materials for injection · Neither Agree nor Disagree
|
1 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
When I use a ready-to-use toxin I spend less materials for injection · Disagree/Strongly disagree
|
0 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Believe that the use of ready-to-use toxin is better for the environment as I produce less waste · Strongly Agree/Agree
|
99 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Believe that the use of ready-to-use toxin is better for the environment as I produce less waste · Neither Agree nor Disagree
|
0 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Believe that the use of ready-to-use toxin is better for the environment as I produce less waste · Disagree/Strongly disagree
|
0 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Feel more confident when injecting a product free from animal and human excipients · Strongly Agree/Agree
|
82 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Feel more confident when injecting a product free from animal and human excipients · Neither Agree nor Disagree
|
17 Participants
|
—
|
|
Investigator Treatment Session Questionnaire
Feel more confident when injecting a product free from animal and human excipients · Disagree/Strongly disagree
|
0 Participants
|
—
|
Adverse Events
Group 1 (Alluzience)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Alluzience)
n=99 participants at risk
Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
Group 2 (Powder BoNT-A: BOTOX/Vistabel)
n=51 participants at risk
Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
|
|---|---|---|
|
General disorders
Injecttion Site Pain
|
11.1%
11/99 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
0.00%
0/51 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
|
General disorders
Injection Site Haematoma
|
1.0%
1/99 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
0.00%
0/51 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
|
General disorders
Injection site pruritus
|
1.0%
1/99 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
0.00%
0/51 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
|
Nervous system disorders
Headache
|
2.0%
2/99 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
0.00%
0/51 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
|
Nervous system disorders
Tension headache
|
2.0%
2/99 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
0.00%
0/51 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/99 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
0.00%
0/51 • Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agree not to present/publish any data or reports collected individually or by subgroup of trial sites prior to first publication based on data obtained from all sites. Investigators can publish results 18 months after the completion of the trial, but Sponsor shall have the right to review any proposed publication before publication/presentation to prevent the disclosure of confidential information. Sponsor can refuse the publication, delay it or request amendment of its contents
- Publication restrictions are in place
Restriction type: OTHER