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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04752774




Registration number
NCT04752774
Ethics application status
Date submitted
3/02/2021
Date registered
12/02/2021

Titles & IDs
Public title
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
Scientific title
An Integrated Phase I/II, Multicentre, Double-blind, Randomised, Dysport and Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity.
Secondary ID [1] 0 0
2020-003623-42
Secondary ID [2] 0 0
D-FR-10200-001
Universal Trial Number (UTN)
Trial acronym
LANTIMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spasticity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - IPN10200
Treatment: Drugs - Placebo
Treatment: Other - Dysport

Experimental: Dose escalation - One single administration of study medication (IPN10200, Dysport or placebo) will be injected in a dose-escalation manner. Dose-escalation will include several cohorts.

Experimental: Dose ranging - Two fixed doses of IPN10200 will be administrated as a single injection into several muscle groups of the upper limb.

Participants will be randomised in the ratio of 3:3:2 (total IPN10200 dose 1: 30 participants; total IPN10200 dose 2: 30 participants; Dysport: 20 participants)

Experimental: Total dose - One single injection of study medication will be administered locally into several muscle groups of the upper limb.

Participants will be randomized in the ratio of 2:1 (Total IPN10200 dose: 30 participants; placebo: 15 participants, resulting in a total of 45 participants in Stage 3).

Or

Participants will be randomized in the ratio of 3:1 (IPN10200 lower dose: 30 participants; placebo: 10 participants, then IPN10200 higher dose: 30 participants; placebo: 10 participants, resulting in a total of 80 participants in Stage 3).


Treatment: Other: IPN10200
Powder and solvent for solution for injection

Treatment: Drugs: Placebo
Powder and solvent for solution for injection

Treatment: Other: Dysport
Powder for solution for injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, severity and nature of treatment emergent adverse events (TEAEs).
Timepoint [1] 0 0
from baseline until the end of study (9 months)
Primary outcome [2] 0 0
Incidence, severity and nature of adverse events of special interest (AESI).
Timepoint [2] 0 0
from baseline until the end of study (9 months)
Primary outcome [3] 0 0
Change from baseline in vital sign parameter (blood pressure)
Timepoint [3] 0 0
9 months
Primary outcome [4] 0 0
Change from baseline in vital sign parameter (Heart rate)
Timepoint [4] 0 0
9 months
Primary outcome [5] 0 0
Change from baseline in clinical laboratory test results.
Timepoint [5] 0 0
9 months
Primary outcome [6] 0 0
Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)
Timepoint [6] 0 0
from baseline until the end of study (9 months)
Primary outcome [7] 0 0
Change from baseline in physical examination findings.
Timepoint [7] 0 0
9 months
Secondary outcome [1] 0 0
Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG)
Timepoint [1] 0 0
from baseline until the end of study (9 months)
Secondary outcome [2] 0 0
Change from Baseline to post-treatment Day 29 in MAS score in the PTMG
Timepoint [2] 0 0
from baseline until port-treatment Day 29
Secondary outcome [3] 0 0
Change from Baseline in MAS score in all injected muscle Groups
Timepoint [3] 0 0
from baseline until the end of study (9 months)
Secondary outcome [4] 0 0
Time to onset - time to the response to treatment (a reduction of at least one grade in the MAS score).
Timepoint [4] 0 0
from baseline until the end of study (9 months)
Secondary outcome [5] 0 0
Peak of effect - maximal decrease in the MAS score from Baseline.
Timepoint [5] 0 0
from baseline until the end of study (9 months)
Secondary outcome [6] 0 0
Time to peak - time to reach the peak of effect (maximal decrease in the MAS score from Baseline).
Timepoint [6] 0 0
from baseline until the end of study (9 months)
Secondary outcome [7] 0 0
Duration of effect - duration between time to onset and last timepoint with a response to Treatment.
Timepoint [7] 0 0
from baseline until the end of study (9 months)
Secondary outcome [8] 0 0
Response to treatment as measured by at least one grade reduction in MAS score in the PTMG from Baseline
Timepoint [8] 0 0
from baseline until the end of study (9 months)
Secondary outcome [9] 0 0
Response to treatment as measured by at least one grade reduction in MAS score in all injected muscles from Baseline
Timepoint [9] 0 0
from baseline until the end of study (9 months)
Secondary outcome [10] 0 0
Physician's Global Assessment (PGA) score of overall treatment response
Timepoint [10] 0 0
from baseline until the end of study (9 months)
Secondary outcome [11] 0 0
Patient Global Impression of Change in the Spastic Clinical Pattern using specific scale (PGI-c)
Timepoint [11] 0 0
from baseline until the end of study (9 months)
Secondary outcome [12] 0 0
Change from Baseline in the Disability Assessment Scale (DAS)
Timepoint [12] 0 0
from baseline until the end of study (9 months)
Secondary outcome [13] 0 0
Reduction of pain in the shoulder (adducted/rotated pattern) using the Numeric Rating Scale
Timepoint [13] 0 0
from baseline until the end of study (9 months)
Secondary outcome [14] 0 0
The number and percentage of participants with presence of IPN10200 and BoNT-A antibodies and titres (binding and neutralising)
Timepoint [14] 0 0
At baseline

Eligibility
Key inclusion criteria
1. Participant must be 18 to 70 years of age inclusive (except for dose escalation must be 18 to 65 years of age) at the time of signing the informed consent.
2. Has spastic hemiparesis following stroke or Traumatic brain injury (TBI)
3. Is at least 6 months post-stroke or TBI
4. Has never received BoNT or if previously treated, should have received their last injection of any commercialized BoNT-A or B at least 4 months prior to study Baseline
5. Has a MAS score =2 in the (PTMG) to be injected
6. Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable.
7. Has angle of spasticity =5° in the PTMG to be injected.
8. Does not have any fixed contractures as defined by:

* Complete fingers extension with Angle of arrest at slow speed (Tardieu Scale) (XV1) =160°
* Complete wrist extension with XV1 =90°
* Complete elbow extension with XV1 =160°
9. Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 30 days preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study.
10. In good health (i.e. absence of any uncontrolled systemic disease or other significant medical condition) as determined by medical history, physical and neurological examinations, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and Investigator's judgment prior to randomization
11. Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study.

A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method (until the end of the study). The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the investigator, the likelihood of adverse events (AEs) related to BoNT treatment.
2. Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).
3. Has a history of hypersensitivity to the investigational medicinal products (or other BoNTs) or any excipient used in their formulation.
4. Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study.
5. Likely treatment with any serotype of BoNT for any condition during the study.
6. Undergone previous surgery to treat spasticity in the affected upper limb.
7. Has initiated physiotherapy within 30 days prior to Baseline (if physiotherapy initiated more than 30 days prior to Baseline and ongoing, the therapy regimen should be maintained at the same frequency and intensity throughout the study if possible or at least up to 3-months post-injection).
8. Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.
9. Has been treated or is likely to be treated with intrathecal baclofen during the 30 days prior to study Baseline or during the course of the study.
10. Current or planned treatment with any medications that interfere either directly or indirectly with neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within 30 days prior to Baseline.
11. Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders. For patients taking vitamin K antagonists, the INR values should be controlled (between 2 and 3)
12. Currently planned or a history of tendon lengthening surgery, significant contracture or muscle atrophy at target joint or muscle in the past 6 months prior to Screening.
13. Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
14. Presence of any other condition (e.g. neuromuscular disorder, muscular dystrophies, cancer cachexia, sarcopenia or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgment of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
15. Pregnant or lactating women, or women of childbearing potential not willing to practice a highly effective form of contraception method at the beginning of the study, for the duration of the study and for the duration of the study
16. Inability to understand protocol procedures and requirements
17. Infection at the injection site(s)
18. A history of drug or alcohol abuse
19. Male participants who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2027
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Vienna
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Pleven
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Ruse
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Sofia
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Veliko Tarnovo
Country [11] 0 0
Czechia
State/province [11] 0 0
Pardubice
Country [12] 0 0
Czechia
State/province [12] 0 0
Prague
Country [13] 0 0
Germany
State/province [13] 0 0
Bonn
Country [14] 0 0
Germany
State/province [14] 0 0
Duesseldorf
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Germany
State/province [16] 0 0
Mainz
Country [17] 0 0
Germany
State/province [17] 0 0
Troisdorf
Country [18] 0 0
Germany
State/province [18] 0 0
Tuebingen
Country [19] 0 0
Hungary
State/province [19] 0 0
Debrecen
Country [20] 0 0
Hungary
State/province [20] 0 0
Gyor
Country [21] 0 0
Hungary
State/province [21] 0 0
Kisvárda
Country [22] 0 0
Hungary
State/province [22] 0 0
Miskolc
Country [23] 0 0
Poland
State/province [23] 0 0
Gdansk
Country [24] 0 0
Poland
State/province [24] 0 0
Katowice
Country [25] 0 0
Poland
State/province [25] 0 0
Kraków
Country [26] 0 0
Poland
State/province [26] 0 0
Oswiecim
Country [27] 0 0
Poland
State/province [27] 0 0
Poznan
Country [28] 0 0
Poland
State/province [28] 0 0
Sandomierz
Country [29] 0 0
Poland
State/province [29] 0 0
Wroclaw
Country [30] 0 0
Spain
State/province [30] 0 0
A Coruña
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Spain
State/province [33] 0 0
Santiago De Compostela
Country [34] 0 0
Spain
State/province [34] 0 0
Vigo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04752774