IPN10200 for Upper Limb Spasticity

(LANTIMA Trial)

Recruiting at 48 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IPN10200 (a form of Botulinum toxin) to determine its safety and effectiveness in reducing spasticity (muscle stiffness) in the upper limbs of adults who have experienced a stroke or traumatic brain injury. The study involves different groups receiving varying doses of IPN10200 or Dysport, another treatment, to identify the optimal dosage balance between safety and effectiveness. Suitable candidates for this trial have experienced upper limb spasticity for at least six months following a stroke or brain injury and have not recently received certain treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both IPN10200 and Dysport are promising in terms of safety for treating upper limb spasticity. Studies have found that Dysport effectively reduces muscle tightness in stroke patients, consistently demonstrating safety across various trials. Dysport was well-tolerated, with no major safety concerns reported.

Previous patients treated with IPN10200 have shown positive safety results in similar treatments. For instance, treatments like IPN10200, which use botulinum toxin, have proven effective and safe for managing spasticity in stroke patients. These findings support ongoing research into IPN10200’s safety.

While specific details about IPN10200's safety in humans are still under study, the current phase of the trial focuses on carefully monitoring its safety and effectiveness. This phase involves a thorough examination to ensure the treatment is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about IPN10200 for upper limb spasticity because it offers a new approach compared to standard treatments like botulinum toxin A injections, such as Dysport. Unlike most existing treatments that rely on a single formulation, IPN10200 explores different dosing strategies, which could potentially provide more tailored and effective relief for patients. Additionally, the possibility of administering IPN10200 as a single injection into multiple muscle groups may simplify treatment and enhance convenience for patients. This innovative approach might lead to faster and more targeted relief from muscle stiffness, making it a promising option in the landscape of spasticity treatments.

What evidence suggests that this trial's treatments could be effective for adult upper limb spasticity?

Research has shown that treatments like IPN10200 and Dysport, which use botulinum toxin, effectively reduce symptoms of muscle tightness in the upper limbs. In this trial, participants will receive either IPN10200 or Dysport in different treatment arms. Studies have found that these treatments lessen involuntary movements and pain and aid joint movement. Dysport, in particular, has improved muscle tone in conditions with excessive muscle tightness. Both IPN10200 and Dysport manage upper limb stiffness after a stroke, reducing tightness and improving movement. Although IPN10200 is newer, it works similarly to other treatments, suggesting it may offer similar benefits. ^{2 3 4 6 7}

Who Is on the Research Team?

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

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 have an infection where I received my injection.

I am not on drugs that affect muscle function.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30796921/

Effectiveness of Botulinum Toxin Treatment for Upper Limb ... Objective: To provide a comprehensive overview of reported effects and scientific robustness of botulinum toxin (BoNT) treatment regarding the main clinical ...

2. medicaljournalssweden.se medicaljournalssweden.se/jrm-cc/article/view/42928/50149

View of Long-term efficacy of spasticity-corrective surgery ... This study evaluated the long-term effectiveness of 2 treatments for upper limb spasticity: surgery and botulinum toxin (BoNT) injections.

3. ahajournals.org ahajournals.org/doi/10.1161/01.STR.31.10.2402

A Randomized, Double-Blind, Placebo-Controlled, Dose ... In recent years, botulinum toxin type A (BtxA) has been shown to be an effective antispasticity agent. The use of BtxA for the relief of upper limb spasticity ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01313299

NCT01313299 | Dysport® Adult Upper Limb Spasticity Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition; Physiotherapy initiated less than 4 weeks before ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S193414821631187X

Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the ... Objective. To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11022071/

A randomized, double-blind, placebo-controlled, dose ... The present study suggests that treatment with Dysport reduces muscle tone in patients with poststroke upper limb spasticity.

7. neurology.org neurology.org/doi/10.1212/WNL.84.14_supplement.S28.001

A Phase III randomized, double-blind, placebo-controlled ... OBJECTIVE: To assess the efficacy and safety of abobotulinumtoxinA (Dysport®) in the treatment of hemiparetic adults with upper limb spasticity (ULS).