What side effects are associated with this type of intervention?

Common treatments for spasticity, such as botulinum toxin injections, can cause side effects including localized muscle weakness, pain at the injection site, and flu-like symptoms. In some cases, patients may experience transient weakness in nearby muscles, which typically resolves within a few weeks. Oral medications like baclofen, tizanidine, and diazepam can cause drowsiness, dizziness, and muscle weakness. It is important to monitor these side effects to balance efficacy and safety in managing spasticity.

What prior FDA approvals exist?

FDA-approved treatments for spasticity include various formulations of botulinum toxin type A, such as onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), and incobotulinumtoxinA (Xeomin). These treatments are used to manage spasticity by inhibiting the release of acetylcholine at the neuromuscular junction, thereby reducing muscle contractions. The efficacy and safety of these treatments have been well-documented, with studies showing significant improvements in muscle tone and functional outcomes. Similar to IPN10200, these treatments are evaluated for their pharmacodynamics to determine the optimal dosing that balances efficacy and safety.

What other types of research exist?

Promising novel alternatives to IPN10200 for treating adult upper limb spasticity include: 1. Botulinum toxin injections, which have been shown to be effective in reducing spasticity in various clinical trials. 2. Non-invasive neuromodulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), which have demonstrated relief in spasticity symptoms. 3. The MS-Spasticity App, a digital therapeutic tool that has shown significant improvement in spasticity management in multiple sclerosis patients and could be adapted for other spasticity conditions. These alternatives offer different mechanisms of action and delivery methods, providing a range of options for personalized treatment plans.

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Botulinum Toxin

IPN10200 for Upper Limb Spasticity (LANTIMA Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Ipsen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has spastic hemiparesis following stroke or Traumatic brain injury (TBI)

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

Must not have

Infection at the injection site(s)

Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to botulinum toxin such as muscle weakness, pain at the injection site, difficulty swallowing, or breathing problems. Other general risks might involve allergic reactions or systemic effects since BoNT can affect neuromuscular function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have muscle stiffness and weakness on one side of my body due to a stroke or brain injury.

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I have not had Botox in the last 4 months.

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I can fully extend my fingers to at least 160°.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection where I received my injection.

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

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I have a diagnosed neuromuscular condition like myasthenia gravis.

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I had surgery for muscle stiffness in my arm.

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I have had or am planning surgery for tight tendons or weak muscles at a specific joint in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in clinical laboratory test results.

Change from baseline in physical examination findings.

Secondary study objectives

Change from Baseline in the Disability Assessment Scale (DAS)

Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG)

Change from Baseline to post-treatment Day 29 in MAS score in the PTMG

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Total doseExperimental Treatment2 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 rangingExperimental Treatment2 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 escalationExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dysport

2011

Completed Phase 4

~140

Placebo

1995

Completed Phase 3

~2670

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Spasticity treatments, such as botulinum toxin (similar to IPN10200), work by blocking acetylcholine release at the neuromuscular junction, leading to muscle relaxation. Other common treatments include baclofen, which acts on GABA receptors to inhibit excitatory neurotransmission in the spinal cord, and tizanidine, an alpha-2 adrenergic agonist that reduces spasticity by inhibiting presynaptic motor neurons. These mechanisms are crucial for spasticity patients as they help in selecting the most appropriate treatment to reduce muscle stiffness and improve mobility, ultimately enhancing their quality of life.

The effects of dosage time and frequency on motor outcomes in children with cerebral palsy: A systematic review.