## Protocol Section
### Identification Module
**NCT ID:** NCT04604379

**Acronym:** DYSCOVER

**Brief Title:** A Study to Review Treatment Outcomes From Treatment With Dysport® Injections in Adults for Upper and/or Lower Limb Focal Spasticity

**Official Title:** A Multicentre, Non-interventional Retrospective Study of Treatment Outcomes From Treatment With Dysport ® (Clostridium Botulinum Type A Toxin-haemagglutinin Complex, Abobotulinumtoxin-A) Injections in Adults for Upper and/or Lower Limb Focal Spasticity in Real-world Clinical Practice in the United Kingdom

#### Organization Study ID Info
**ID:** A-GB-52120-277
#### Organization
**Class:** INDUSTRY
**Full Name:** Ipsen
### Status Module
#### Completion Date
**Date:** 2021-05-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-06-21

**Type:** ACTUAL

**Last Update Submit Date:** 2021-06-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-05-28

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-04

**Type:** ACTUAL

**Status Verified Date:** 2021-06

#### Study First Post Date
**Date:** 2020-10-27
**Type:** ACTUAL
**Study First Submit Date:** 2020-10-21
**Study First Submit QC Date:** 2020-10-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Ipsen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this retrospective study is to describe the real-world outcomes with the treatment of adult patients with Dysport® injections for focal upper limb spasticity (ULS) and/or focal lower limb spasticity (LLS) in NHS hospital settings in the United Kingdom (UK).

### Conditions Module

**Conditions:**

- Upper and/or Lower Limb Focal Spasticity

**Keywords:**

- Spasticity

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 123

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Average total dose of AboBoNT-A for focal upper limb and/or lower limb spasticity per treatment session

**Time Frame:** From baseline (when each patient received their first treatment) to 52 weeks (±6 weeks) post baseline

**Measure:** Average interval between AboBoNT-A injections throughout the observation period for focal ULS and/or LLS

**Time Frame:** From baseline to 52 weeks (±6 weeks) post baseline

#### Secondary Outcomes

**Measure:** Average age at diagnosis of neurological condition

**Time Frame:** Baseline

**Measure:** Average age at first AboBoNT-A injection

**Time Frame:** Baseline

**Measure:** Average age at diagnosis of spasticity

**Time Frame:** Baseline

**Measure:** Sex distribution (Male, Female)

**Time Frame:** Baseline

**Measure:** Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other)

**Time Frame:** Baseline

**Description:** Data collected at index date up to 6 weeks prior to index date (when each patient received their first treatment)

**Measure:** Presence of location of spasticity (specify: right lower limb, left lower limb, right upper limb, left upper limb, unilateral, bilateral spasticity for lower and upper limb)

**Time Frame:** Baseline

**Measure:** Presence of previous spasticity-related treatments ongoing at index event, if available: antispasticity medications, pain medications and opioids, neurolytic agent, surgery, physiotherapy and occupational therapy

**Time Frame:** Baseline

**Measure:** Presence of comorbidities: bowel conditions (irritable bowel syndrome, irritable bowel disease), urinary tract infections, chest infections, anxiety or depression, alcohol dependence/substance abuse.

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients diagnosed with focal ULS and/or LLS for whom aboBoNT-A (Dysport®) was prescribed in line with the SmPC (according to clinician judgement).
* Patients initiated on aboBoNT-A for focal ULS after the 31st January 2016 and/or for focal LLS after the 06th December 2016.
* Patients receiving ≥1 injection(s) (i.e. ≥1 treatment cycle) of aboBoNT-A during the observation period, in line with Dysport® Summary of Product Characteristics (SmPC).
* Patients aged ≥18 years old at the time of the first aboBoNT-A injection for focal ULS and/or LLS.
* Patient is naïve to treatment with any type of BoNT-A during the 6 months prior to initiation of aboBoNT-A.
* Patients treated at the participating centre for the duration of the observation period, with data recorded in the medical records available for review.

Exclusion Criteria:

* Patients with an interval of \<12 weeks between aboBoNT-A treatments
* Patients are participating (or who have participated) in an interventional clinical trial of an investigational medicinal product indicated for spasticity which may influence and confound the real-world data collected for this study.
* Patients treated with aboBoNT-A off-license, this may include off-license indications, muscles indicated for injection or dosing

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 3-5 Secondary care centres in the UK

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** London

**Country:** United Kingdom

**Facility:** Kings College Hospital

**Location 2:**

**City:** Norwich

**Country:** United Kingdom

**Facility:** Colman Hospital

**Location 3:**

**City:** York

**Country:** United Kingdom

**Facility:** York Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Ipsen

**Name:** Ipsen Medical Director

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009122

- Term: Muscle Hypertonia

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12085

- Name: Muscle Spasticity

- Relevance: HIGH

- As Found: Spasticity

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12079

- Name: Muscle Hypertonia

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009128

- Term: Muscle Spasticity

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M21257

- Name: Botulinum Toxins, Type A

- Relevance: LOW

- As Found: Unknown

- ID: M250193

- Name: abobotulinumtoxinA

- Relevance: LOW

- As Found: Unknown

- ID: M9476

- Name: Hemagglutinins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
