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A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.

Study acronym: LANTIMA
StatusRecruiting
PhasePhase 1/2
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: Dysport (Biological), IPN10200 (Biological), Placebo (Drug) to Corabotase (Biological), Dysport (Biological), Placebo (Drug)v48
  2. Primary and study completion pushed from Oct 30, 2027 to Mar 30, 2029 Site details revised at 4 of 81 sitesv47 Show 1 more changeShow less
    • Site details revised at 4 of 81 sites
  3. Study sites: 80 to 81v46
  4. Study sites: 61 to 80v45
  5. Study sites: 57 to 61v44
Show 42 earlier versionsHide 42 earlier versions
  1. 3 versions Re-verified since Aug 26, 2025, no change to tracked fieldsv41-v43
  2. Trial status: Active, Not Recruiting to Recruiting Study sites: 39 to 57v40 Show 1 more changeShow less
    • Study sites: 39 to 57
  3. 4 versions Re-verified since Mar 31, 2025, no change to tracked fieldsv36-v39
  4. Primary endpoints revised (7) Secondary endpoints revised (14)v35 Show 1 more changeShow less
    • Secondary endpoints revised (14)

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Dec 20, 2024, no change to tracked fieldsv33-v34
  6. Study sites: 40 to 39v32
  7. 2 versions Re-verified since Sep 30, 2024, no change to tracked fieldsv30-v31
  8. Primary completion date: Sep 30, 2024 to Oct 30, 2027 Enrollment target: 209 to 240 · Completion date: Jun 30, 2026 to Oct 30, 2027v29 Show 2 more changesShow less
    • Enrollment target: 209 to 240
    • Completion date: Jun 30, 2026 to Oct 30, 2027
  9. Re-verified, no change to tracked fieldsv28
  10. Trial status: Recruiting to Active, Not Recruiting Study sites: 54 to 40v27 Show 1 more changeShow less
    • Study sites: 54 to 40
  11. Completion date: Sep 30, 2024 to Jun 30, 2026v26
  12. 2 versions Re-verified since Feb 27, 2024, no change to tracked fieldsv24-v25
  13. Study sites: 53 to 54v23
  14. Site details revised at 4 of 53 sitesv22
  15. Primary and study completion dates: Mar 29, 2024 to Sep 30, 2024v21
  16. Site details revised at 6 of 53 sitesv20
  17. Study sites: 45 to 53v19
  18. 2 versions Re-verified since Jul 12, 2023, no change to tracked fieldsv17-v18
  19. Site details revised at 2 of 45 sitesv16
  20. Site details revised at 1 of 45 sitesv15
  21. Study sites: 41 to 45v14
  22. Re-verified, no change to tracked fieldsv13
  23. Study sites: 37 to 41v12
  24. Site details revised at 2 of 37 sitesv11
  25. Re-verified, no change to tracked fieldsv10
  26. Primary endpoints: 3 to 7 Eligibility criteria shortened, about 41 words · Secondary endpoints: 13 to 14 · Study sites revised (37) · 1 morev9 Show 4 more changesShow less
    • Eligibility criteria shortened, about 41 words
    • Secondary endpoints: 13 to 14
    • Study sites revised (37)
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  27. Site details revised at 1 of 37 sitesv8
  28. Study sites: 34 to 37v7
  29. Study sites: 28 to 34v6
  30. Site details revised at 1 of 28 sitesv5
  31. Eligibility criteria shortened, about 12 words Study sites revised (28)v4 Show 1 more changeShow less
    • Study sites revised (28)

    See this version in full on ClinicalTrials.gov ↗

  32. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 28 · Start date changed from estimate of Apr 6, 2021 to Apr 29, 2021 · Eligibility criteria shortened, about 58 wordsv3 Show 3 more changesShow less
    • Study sites: 0 to 28
    • Start date changed from estimate of Apr 6, 2021 to Apr 29, 2021
    • Eligibility criteria shortened, about 58 words

    See this version in full on ClinicalTrials.gov ↗

  33. Start date: Mar 15, 2021 to Apr 6, 2021 Interventions: Dysport (Drug), IPN10200 (Drug), Placebo (Drug) to Dysport (Biological), IPN10200 (Biological), Placebo (Drug)v2 Show 1 more changeShow less
    • Interventions: Dysport (Drug), IPN10200 (Drug), Placebo (Drug) to Dysport (Biological), IPN10200 (Biological), Placebo (Drug)
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ipsen
46 trials monitored
See 4 trials at risk
The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total Corabotase doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
Trial Details
NCT Number NCT04752774
Lead Sponsor Ipsen
Conditions Spasticity
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov