IPN10200 for Upper Limb Spasticity

(LANTIMA Trial)

Recruiting at 41 trial locations

Overseen By Ipsen Recruitment Enquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ipsen

Must not be taking: Antidepressants, Baclofen, Neuromuscular blockers, others

Disqualifiers: Neuromuscular disorders, Anxiety, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that certain medications, like muscle relaxants and benzodiazepines, be stable for at least 30 days before starting and throughout the study. Some medications that interfere with neuromuscular transmission must be stopped 30 days before the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug IPN10200 for treating upper limb spasticity?

Research shows that Dysport, a form of botulinum toxin type A, is effective in treating upper limb spasticity, with 84% of patients achieving their treatment goals, such as reduced muscle tightness and improved movement. It is generally well tolerated, with most side effects being mild and temporary. ^{1 2 3 4 5}

Is IPN10200 (Dysport, Botulinum toxin) safe for treating upper limb spasticity?

Dysport, a form of botulinum toxin type A, has been used safely for over 20 years to treat muscle conditions like spasticity. Studies show it is generally well tolerated, with most side effects being mild and temporary. It has been safely used in doses between 500 and 1500 units for upper limb spasticity. ^{1 2 4 5 6}

How does the drug IPN10200 (Dysport, Botulinum toxin) differ from other treatments for upper limb spasticity?

IPN10200, also known as Dysport, is unique because it uses botulinum toxin type A, which is injected directly into the muscles to reduce spasticity (muscle stiffness). This treatment is notable for its targeted approach, potentially improving muscle function and reducing pain, and it is often guided by electromyography (EMG) to ensure precise delivery. ^{5 7 8 9 10}

What is the purpose of this trial?

This trial is testing a medication called IPN10200 to see how safe and effective it is for adults with stiff muscles in their arms. Researchers are trying different doses to find the best one that works well without causing too many side effects. The goal is to help reduce muscle stiffness in these patients.

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

Adults aged 18-70 with upper limb spasticity due to stroke or traumatic brain injury, at least 6 months post-event. They must not have had BoNT treatments in the last 4 months and should have a certain level of muscle stiffness (MAS score ≥2). Participants need stable health without severe diseases that could worsen with treatment, and women must not be pregnant or breastfeeding.

Inclusion Criteria

You have a spasticity angle of 5 degrees or more in the muscle that will be treated.

My therapy and medication for muscle issues have been stable for the last 30 days.

I do not have any permanent stiffness in my joints.

Exclusion Criteria

I am not on drugs that affect muscle function.

I have an infection where I received my injection.

I have had treatments with phenol or alcohol in my arm before this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

9 months

Dose Ranging

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

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dysport
• IPN10200

Trial Overview The trial is testing IPN10200's safety and effectiveness for treating adult upper limb spasticity compared to a placebo and Dysport. It aims to find the best dose based on how well it works versus any side effects. Patients will receive varying doses of IPN10200 to determine its impact on muscle spasms.

Participant Groups

Group I: Total dose Experimental Treatment 2 Interventions

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).

Group II: Dose ranging Experimental Treatment 2 Interventions

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)

Group III: Dose escalation Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Findings from Research

A survey of Dysport injectors across 5 EU countries revealed that they generally follow product-labeling recommendations for administering botulinum neurotoxin type A, indicating a good understanding of its use in conditions like cervical dystonia and spasticity.

Despite this familiarity, some injectors occasionally deviate from the recommended practices, emphasizing the need for ongoing education about potential adverse events such as dysphagia and muscle weakness associated with Dysport treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysport (botulinum toxin type A) in routine therapeutic usage: a telephone needs assessment survey of European physicians to evaluate current awareness and adherence to product labeling changes. Hubble, J., Schwab, J., Hubert, C., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Botulinum toxin A (Dysport®): in dystonias and focal spasticity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The lowest effective dose of botulinum A toxin in adult patients with upper limb spasticity. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

[Botulinum toxin type A treatment of upper limb spasticity]. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Dysport (botulinum toxin type A) in routine therapeutic usage: a telephone needs assessment survey of European physicians to evaluate current awareness and adherence to product labeling changes. [2022]

7. Scotland pubmed.ncbi.nlm.nih.gov

Treatment of upper limb dystonia with botulinum toxin. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA Efficacy/Safety in Upper-Limb Spasticity in Pediatric Cerebral Palsy: Randomized Controlled Trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Treatment of chronic limb spasticity with botulinum toxin A. [2022]