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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03992404




Registration number
NCT03992404
Ethics application status
Date submitted
18/06/2019
Date registered
20/06/2019
Date last updated
31/10/2024

Titles & IDs
Public title
Study to Compare the Efficacy and Safety of NT 201 (botulinum Toxin) with Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Scientific title
Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension with or Without Combined Upper Limb Treatment
Secondary ID [1] 0 0
2018-001639-35
Secondary ID [2] 0 0
M602011014
Universal Trial Number (UTN)
Trial acronym
PATTERN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NT 201
Treatment: Drugs - Placebo

Experimental: NT 201 (IncobotulinumtoxinA, Xeomin) - Main Period (1 treatment cycle): subjects to receive intramuscular injection of NT 201 (400 units) into muscles of the lower limb.

Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.

Placebo comparator: Placebo - Main Period (1 treatment cycle): subjects to receive intramuscular placebo injection into muscles of the lower limb.

Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.


Treatment: Drugs: NT 201
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Treatment: Drugs: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6
Timepoint [1] 0 0
Baseline to week 4-6
Primary outcome [2] 0 0
Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
Timepoint [2] 0 0
Week 4-6
Primary outcome [3] 0 0
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Timepoint [3] 0 0
Baseline to week 12
Secondary outcome [1] 0 0
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
Timepoint [1] 0 0
Baseline to week 6
Secondary outcome [2] 0 0
Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6
Timepoint [2] 0 0
Week 4-6
Secondary outcome [3] 0 0
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
Timepoint [3] 0 0
Week 4-6

Eligibility
Key inclusion criteria
* Female or male subject = 18 years and = 85 years at screening
* Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
* Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
* Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
* Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
* At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
* For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
* Activated partial thromboplastin time [aPTT] = 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
* International normalized ratio [INR] value of = 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
* Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
* Body weight < 50 kg
* Severe atrophy of the target limb muscles
* Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
* Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: Surgical Intervention; Alcohol or phenol block; Muscle afferent block
* Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
* Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
* Infection or inflammation at the injection sites
* Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
* Pregnancy (as verified by a positive pregnancy test) or breast feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St George Hospital, Department of Rehabilitation Medicine, Merz Investigational Site #0610004 - Kogarah
Recruitment hospital [2] 0 0
Royal Melbourne Hospital, Department of Rehabilitation Medicine; Merz Investigational Site #0610002 - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arkansas
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California
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Connecticut
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Florida
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Massachusetts
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Missouri
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New Jersey
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New York
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Pennsylvania
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Texas
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Wisconsin
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Pellenberg
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Belgium
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Yvoir
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Canada
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Edmonton
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Czechia
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Brno
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Czechia
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Ostrava
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Pardubice
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Prague
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France
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Garches
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France
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Lille
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France
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Rennes
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France
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France
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Lübeck
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Wiesbaden
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Gyor
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Foggia
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Italy
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Verona
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Bergen
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Bjornemyr
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Katowice
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Krakow
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Lodz
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Lublin
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Warsaw
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Krasnoyarsk
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Moscow
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Saint Petersburg
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Slovakia
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Bratislava
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Trnava
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Spain
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Huelva
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Madrid
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Terrassa
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Switzerland
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Bern
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Switzerland
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Lausanne
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Meyriez
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Ukraine
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Kharkiv
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Ukraine
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Lviv
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Ukraine
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Rivne
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Ukraine
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Uzhgorod
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United Kingdom
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Cambridge
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Exeter
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Liverpool
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merz Pharmaceuticals GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.

The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
Trial website
https://clinicaltrials.gov/study/NCT03992404
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Merz Medical Expert
Address 0 0
Merz Pharmaceuticals GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Public Disclosure Manager
Address 0 0
Country 0 0
Phone 0 0
+49 69 1503 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03992404