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Botulinum Toxin

IPN10200 for Upper Limb Spasticity (LANTIMA Trial)

Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

LANTIMA Trial Summary

This trial aims to find the best dose of a drug to safely treat upper limb spasticity in adults.

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.Check my eligibility
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.See study design
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.

LANTIMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have muscle stiffness and weakness on one side of my body due to a stroke or brain injury.
Select...
I have not had Botox in the last 4 months.
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I can fully extend my fingers to at least 160°.

LANTIMA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in clinical laboratory test results.
Change from baseline in physical examination findings.
Change from baseline in vital sign parameter (Heart rate)
+4 more
Secondary outcome measures
Change from Baseline in MAS score in all injected muscle Groups
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)
+11 more

LANTIMA 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
Placebo
1995
Completed Phase 3
~2670
Dysport
2011
Completed Phase 4
~140

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
346 Previous Clinical Trials
73,091 Total Patients Enrolled
6 Trials studying Spasticity
869 Patients Enrolled for Spasticity
Ipsen Medical DirectorStudy DirectorIpsen
258 Previous Clinical Trials
55,080 Total Patients Enrolled
4 Trials studying Spasticity
560 Patients Enrolled for Spasticity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor enroll participants over thirty years in age?

"The age restrictions for this clinical trial are 18 years of age and above, with a maximum threshold of 70."

Answered by AI

For what therapeutic purposes is dose ranging typically utilized?

"Dose ranging is employed to address urinary incontinence, along with spinal cord injury, botox injections, and overactive bladder syndrome."

Answered by AI

Is enrollment for this clinical trial still ongoing?

"Clinicaltrials.gov reports that this clinical trial is actively looking for participants, with the study being added on April 29th 2021 and most recently updated on September 28th 2023."

Answered by AI

How many sites are hosting this research endeavor?

"Currently, 42 clinical trial sites are enrolling patients in the study. These locations span from Prague and Hamburg to Mainz and other cities; thus, it is recommended that you find a nearby site for convenience when participating."

Answered by AI

How many participants are actively engaged in this trial?

"This medical study requires the enrollment of 209 eligible participants, who can join from a variety of hospitals such as General University Hospital in Prague and Clinic of Neurology in Kansas. Similarly, potential patients may also explore opportunities at University Hospital Hamburg-Eppendorf or Clinic and Polyclinic of Neurology located in Michigan."

Answered by AI

Have there been other investigations relating to varied dosages of a particular drug?

"At present, the medical field has 46 active trials exploring dose-ranging. Of these studies, 15 are in Phase 3 and 692 sites host clinical trials on this topic. Most of these research centres are located in Farmington Hills, Michigan."

Answered by AI

Does my health profile meet the requirements for participating in this clinical research?

"This trial is currently recruiting 209 adults aged 18-70 with spasticity. To be eligible, patients must meet the following requirements: they should have experienced a stroke or traumatic brain injury at least 6 months prior to enrollment; never received any botulinum toxin treatments (or not within 4 months of Baseline); score ≥2 on Modified Ashworth Scale for injected muscle group; demonstrate an angle of spasticity ≥5° in targeted PTMG; and exhibit complete fingers extension with Angle of arrest at slow speed≥160°, wrist extension≥90° and elbow extension≥160°(as measured by Tard"

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
2021. "A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752774.
~25 spots leftby Sep 2024
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