NCT04752774 · Ipsen
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
(LANTIMA)
What this study is about
The purpose of the study is to assess the safety and effectiveness of increasing doses of IPN10200 with the aim to evaluate the how the drug affects the body (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best effectiveness/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
View original scientific description
The purpose of the study is to assess the safety and efficacy of increasing doses of IPN10200 with the aim to evaluate the Pharmacodynamics (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
Interventions
BIOLOGICAL
IPN10200
Powder and solvent for solution for injection
DRUG
Placebo
Powder and solvent for solution for injection
BIOLOGICAL
Dysport
Powder for solution for injection
Primary outcome measures
Percentage of participants with treatment emergent adverse events (TEAEs).
Time frame: From baseline until the end of study (9 months)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants with adverse events of special interest (AESI).
Time frame: From baseline until the end of study (9 months)
Change from baseline in vital sign parameter (blood pressure)
Time frame: 9 months
Change from baseline in vital sign parameter (Heart rate)
Time frame: 9 months
Change from baseline in clinical laboratory test results.
Time frame: 9 months
Number and percentage of participants with low, normal or high values and normal or abnormal examinations will be presented.
Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)
Time frame: From baseline until the end of study (9 months)
Change from baseline in physical examination findings.
Time frame: 9 months
Number of Participants with change in physical examination findings
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 m
Where
- Downey, California
- Overland Park, Kansas
- Farmington Hills, Michigan
- Elkins Park, Pennsylvania
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations