Trial Outcomes & Findings for Dysport in Post-Surgical Neuralgia (NCT NCT03663101)

NCT ID: NCT03663101

Last Updated: 2021-01-12

Results Overview

The time to onset of effect was defined as the time to a decrease from baseline of two points or greater in the spontaneous NRS score. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Only descriptive statistical analysis was performed for this outcome measure.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
• Results posted on: 2021-01-12

Participant Flow

This Phase II proof-of-concept study was conducted at single investigational site in the United Kingdom between 30 October 2018 and 08 November 2019. The study consisted of two sequential parts: Part A (Pre-randomisation run-in period) and Part B (Randomised double-blind period). Part A was considered as an extended screening period.

Part A was conducted to identify participants who would potentially benefit from Dysport® injection, considered as 'responders'. Part B was a double-blind study of Dysport or placebo injection in responders from Part A. Of the 46 participants who were included in Part A, 17 were responders. Of which, 16 participants were randomised into Part B of the study.

Participant milestones

Measure	Placebo Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 milliliters (mL).	Dysport 2.5 U/Injection Site Participants received a single dose of Dysport 2.5 units (U) intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Overall Study STARTED	4	3	5	4
Overall Study COMPLETED	4	3	5	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dysport in Post-Surgical Neuralgia

Baseline characteristics by cohort

Measure	Placebo n=4 Participants Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 Participants Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 Participants Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 Participants Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.	Total n=16 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	49.7 years STANDARD_DEVIATION 6.0 • n=7 Participants	46.0 years STANDARD_DEVIATION 11.3 • n=5 Participants	48.8 years STANDARD_DEVIATION 16.7 • n=4 Participants	50.0 years STANDARD_DEVIATION 11.6 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.

Population: Randomised population included all participants randomised in the double-blind period (Part B). Only participants who reached the time to onset were analysed.

The time to onset of effect was defined as the time to a decrease from baseline of two points or greater in the spontaneous NRS score. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Only descriptive statistical analysis was performed for this outcome measure.

Outcome measures

Measure	Placebo n=4 Participants Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 Participants Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 Participants Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 Participants Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Time to Onset of Effect in the Spontaneous Numerical Rating Scale (NRS) Score Worst NRS score	4.41 days Standard Deviation 4.92	15.11 days Standard Deviation 25.17	29.45 days Standard Deviation 39.82	0.65 days Standard Deviation 0.32
Time to Onset of Effect in the Spontaneous Numerical Rating Scale (NRS) Score Average NRS score	6.75 days Standard Deviation 2.74	31.63 days Standard Deviation 53.78	4.60 days Standard Deviation 6.55	0.90 days Standard Deviation 0.03

PRIMARY outcome

Timeframe: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.

Population: Randomised population included all participants randomised in the double-blind period (Part B).

The peak effect was defined as the maximal decrease from baseline in the spontaneous NRS score over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Greater reductions in change from baseline correspond to greater pain relief.

Outcome measures

Measure	Placebo n=4 Participants Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 Participants Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 Participants Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 Participants Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Peak Effect in the Spontaneous NRS Score Worst NRS score	-2.36 score on a scale Standard Deviation 1.58	-4.73 score on a scale Standard Deviation 0.55	-3.54 score on a scale Standard Deviation 2.15	-2.82 score on a scale Standard Deviation 2.91
Peak Effect in the Spontaneous NRS Score Average NRS score	-2.52 score on a scale Standard Deviation 0.91	-3.53 score on a scale Standard Deviation 0.45	-3.72 score on a scale Standard Deviation 1.57	-2.12 score on a scale Standard Deviation 2.37

PRIMARY outcome

Timeframe: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.

Population: Randomised population included all participants randomised in the double-blind period (Part B).

The time to peak effect was defined as the time to reach the peak effect over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours."

Outcome measures

Measure	Placebo n=4 Participants Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 Participants Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 Participants Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 Participants Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Time to Peak Effect in the Spontaneous NRS Score Worst NRS score	10.63 days Standard Deviation 10.18	33.46 days Standard Deviation 51.41	41.94 days Standard Deviation 35.72	3.11 days Standard Deviation 1.56
Time to Peak Effect in the Spontaneous NRS Score Average NRS score	12.51 days Standard Deviation 7.26	33.13 days Standard Deviation 52.51	11.04 days Standard Deviation 11.58	26.49 days Standard Deviation 49.89

PRIMARY outcome

Timeframe: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.

Population: Randomised population included all participants randomised in the double-blind period (Part B). Only participants who reached the time to onset were analysed.

The duration of effect was defined as the duration between time to onset and last timepoint for which decrease from baseline in the spontaneous NRS score was two points or greater. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours."

Outcome measures

Measure	Placebo n=4 Participants Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 Participants Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 Participants Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 Participants Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Duration of Effect in the Spontaneous NRS Score Worst NRS score	86.04 days Standard Deviation 25.52	86.68 days Standard Deviation 23.89	66.80 days Standard Deviation 44.28	110.52 days Standard Deviation 0.74
Duration of Effect in the Spontaneous NRS Score Average NRS score	53.53 days Standard Deviation 51.44	65.17 days Standard Deviation 58.21	102.75 days Standard Deviation 18.36	110.02 days Standard Deviation 1.45

SECONDARY outcome

Timeframe: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.

Population: Randomised population included all participants randomised in the double-blind period (Part B).

Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Greater reductions in change from baseline correspond to greater pain relief.

Outcome measures

Measure	Placebo n=4 Participants Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 Participants Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 Participants Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 Participants Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily worst NRS score: Week 2	-0.6 score on a scale Standard Deviation 0.9	-2.1 score on a scale Standard Deviation 2.1	-1.4 score on a scale Standard Deviation 3.5	-1.1 score on a scale Standard Deviation 2.7
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily worst NRS score: Baseline	5.1 score on a scale Standard Deviation 1.0	5.1 score on a scale Standard Deviation 1.0	5.3 score on a scale Standard Deviation 1.6	5.8 score on a scale Standard Deviation 0.9
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily worst NRS score: Week 4	-1.6 score on a scale Standard Deviation 1.8	-2.1 score on a scale Standard Deviation 1.8	-1.4 score on a scale Standard Deviation 4.2	-1.6 score on a scale Standard Deviation 2.7
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily worst NRS score: Week 6	-1.1 score on a scale Standard Deviation 0.7	-0.1 score on a scale Standard Deviation 1.0	-1.7 score on a scale Standard Deviation 2.9	-1.6 score on a scale Standard Deviation 2.6
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily worst NRS score: Week 12	-0.5 score on a scale Standard Deviation 1.4	-1.4 score on a scale Standard Deviation 0.6	-0.7 score on a scale Standard Deviation 1.1	-0.8 score on a scale Standard Deviation 3.3
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily worst NRS score: Week 16	-0.0 score on a scale Standard Deviation 2.0	-1.4 score on a scale Standard Deviation 1.1	-1.3 score on a scale Standard Deviation 3.1	-0.3 score on a scale Standard Deviation 1.7
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily average NRS score: Baseline	4.5 score on a scale Standard Deviation 1.1	3.9 score on a scale Standard Deviation 1.0	4.7 score on a scale Standard Deviation 1.2	4.9 score on a scale Standard Deviation 1.2
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily average NRS score: Week 2	-0.9 score on a scale Standard Deviation 1.0	-2.0 score on a scale Standard Deviation 1.8	-2.1 score on a scale Standard Deviation 2.8	-1.7 score on a scale Standard Deviation 2.5
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily average NRS score: Week 4	-1.6 score on a scale Standard Deviation 1.9	-1.9 score on a scale Standard Deviation 1.3	-2.1 score on a scale Standard Deviation 3.2	-1.4 score on a scale Standard Deviation 2.0
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily average NRS score: Week 6	-1.0 score on a scale Standard Deviation 0.9	-0.4 score on a scale Standard Deviation 2.0	-2.0 score on a scale Standard Deviation 2.6	-1.4 score on a scale Standard Deviation 2.0
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily average NRS score: Week 12	-0.5 score on a scale Standard Deviation 1.6	-1.5 score on a scale Standard Deviation 0.6	-1.2 score on a scale Standard Deviation 1.9	-0.6 score on a scale Standard Deviation 2.5
Change From Baseline in the Spontaneous NRS Score Throughout the Study Daily average NRS score: Week 16	-0.6 score on a scale Standard Deviation 1.5	-0.9 score on a scale Standard Deviation 0.8	-1.6 score on a scale Standard Deviation 2.3	-0.4 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Part B: Baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) and Weeks 6 and 12

Population: Randomised population included all participants randomised in the double-blind period (Part B).

For stimulus-evoked NRS score during Quantitative Sensory Testing, participants were submitted to stimuli of various nature (light touch, pressure and temperature) applied to the painful area. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Static mechanical allodynia is the response to light sustained normally innocuous pressure against the skin. Dynamic mechanical allodynia is the response to a normally innocuous light moving mechanical stimulus on the skin. Temporal summation is a condition, which demonstrates an increased perception of pain to repetitive painful stimuli.

Outcome measures

Measure	Placebo n=4 Participants Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 Participants Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 Participants Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 Participants Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Static mechanical allodynia: Baseline	1.3 score on a scale Standard Deviation 1.5	3.0 score on a scale Standard Deviation 3.6	4.2 score on a scale Standard Deviation 1.1	4.5 score on a scale Standard Deviation 3.1
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Static mechanical allodynia: Week 6	1.0 score on a scale Standard Deviation 1.2	-1.7 score on a scale Standard Deviation 4.0	-2.6 score on a scale Standard Deviation 1.8	-1.0 score on a scale Standard Deviation 5.5
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Static mechanical allodynia: Week 12	0.8 score on a scale Standard Deviation 1.0	-0.3 score on a scale Standard Deviation 5.7	-2.0 score on a scale Standard Deviation 1.4	-0.8 score on a scale Standard Deviation 5.1
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Dynamic mechanical allodynia: Baseline	1.3 score on a scale Standard Deviation 1.0	2.3 score on a scale Standard Deviation 3.2	2.4 score on a scale Standard Deviation 1.7	5.3 score on a scale Standard Deviation 1.0
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Dynamic mechanical allodynia: Week 6	-0.5 score on a scale Standard Deviation 1.0	-1.7 score on a scale Standard Deviation 2.1	-2.0 score on a scale Standard Deviation 1.9	-2.5 score on a scale Standard Deviation 2.6
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Dynamic mechanical allodynia: Week 12	-0.3 score on a scale Standard Deviation 2.1	-1.3 score on a scale Standard Deviation 1.5	-0.2 score on a scale Standard Deviation 1.5	-2.0 score on a scale Standard Deviation 2.7
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Temporal summation: Baseline	1.5 score on a scale Standard Deviation 1.3	0.3 score on a scale Standard Deviation 1.5	3.6 score on a scale Standard Deviation 3.0	1.8 score on a scale Standard Deviation 2.1
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Temporal summation: Week 6	1.8 score on a scale Standard Deviation 2.1	0.3 score on a scale Standard Deviation 0.6	1.8 score on a scale Standard Deviation 1.1	2.8 score on a scale Standard Deviation 1.7
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12 Temporal summation: Week 12	2.0 score on a scale Standard Deviation 0.8	0.3 score on a scale Standard Deviation 3.1	1.4 score on a scale Standard Deviation 1.1	2.8 score on a scale Standard Deviation 1.7

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dysport 2.5 U/Injection Site

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dysport 10 U/Injection Site

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Dysport 20 U/Injection Site

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=4 participants at risk Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 participants at risk Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 participants at risk Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 participants at risk Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Metabolism and nutrition disorders Pancreatogenous diabetes	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).

Other adverse events

Measure	Placebo n=4 participants at risk Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.	Dysport 2.5 U/Injection Site n=3 participants at risk Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 10 U/Injection Site n=5 participants at risk Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.	Dysport 20 U/Injection Site n=4 participants at risk Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
Nervous system disorders Headache	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	75.0% 3/4 • Number of events 3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Nervous system disorders Dizziness	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Nervous system disorders Hyporeflexia	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Nervous system disorders Paraesthesia	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Nervous system disorders Sensory loss	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Infections and infestations Nasopharyngitis	50.0% 2/4 • Number of events 3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Infections and infestations Rash pustular	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Infections and infestations Urinary tract infection	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Vomiting	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Gastric mucosa erythema	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Hiatus hernia	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Nausea	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Pancreatic failure	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Gastrointestinal disorders Pancreatitis acute	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
General disorders Injection site bruising	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
General disorders Injection site rash	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Eye disorders Vision blurred	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Blood and lymphatic system disorders Lymphadenitis	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Congenital, familial and genetic disorders Hereditary non-polyposis colorectal cancer syndrome	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Immune system disorders Seasonal allergy	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Investigations Blood triglycerides increased	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 2 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Product Issues Device physical property issue	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Psychiatric disorders Depressed mood	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Renal and urinary disorders Urinary retention	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/3 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/5 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).	0.00% 0/4 • Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks. Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).

Additional Information

Medical Director

Ipsen Innovation SAS

Phone: see email

Email: clinical.trials@ipsen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place