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A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults

Study acronym: CATALPA
StatusRecruiting
PhasePhase 2
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 44 to 45v16
  2. Interventions: IPN10200 (Biological), Placebo (Other) to Corabotase (Biological), Placebo (Other)v15
  3. Re-verified, no change to tracked fieldsv14
  4. Site details revised at 4 of 44 sitesv13
  5. Site details revised at 7 of 44 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 3 of 44 sitesv11
  2. 2 versions Re-verified since Dec 29, 2025, no change to tracked fieldsv9-v10
  3. Site details revised at 10 of 44 sitesv8
  4. Re-verified, no change to tracked fieldsv7
  5. Site details revised at 9 of 44 sitesv6
  6. Primary completion date: Feb 2026 to Mar 26, 2027 Completion date: Nov 2027 to Nov 5, 2027 · Site details revised at 13 of 44 sitesv5 Show 2 more changesShow less
    • Completion date: Nov 2027 to Nov 5, 2027
    • Site details revised at 13 of 44 sites
  7. Study sites: 8 to 44v4
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8v3 Show 1 more changeShow less
    • Study sites: 0 to 8
  9. Start date: Apr 30, 2025 to Jun 30, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this study is to evaluate the efficacy and safety of the study drug, Corabotase (also known as IPN10200), and to assess how well it works when compared with placebo in treating Cervical Dystonia (CD) in adults. CD can cause a series of abnormalities and symptoms in the head and neck that can lead to neck pain and stiffness, and headaches. CD is believed to involve deep parts within the brain that control movement, but genetic factors, environmental factors, and abnormalities in the brain may also play a role. The usual treatment for CD includes injecting BoNT into the affected muscles, but the treatment only lasts about 3 months. Corabotase is designed to last for a longer period. The study will consist of two periods: 1. A Screening Period of up to 4 weeks (28 days) to assess whether a participant can take part in the study and requires at least one visit. 2. A Treatment Period of 36 weeks. On Day 1 of the treatment period, participants will receive either Corabotase Dose A or Dose B (additional participants may receive Corabotase Dose C) of the study drug, or placebo distributed into different muscles in the head, neck and shoulders. Participants may continue some other medications, but details need to be recorded. There will be 10 visits to the clinic in person and one remote visits (phone call) (12 visits to the clinic for participants who receive Dose C). Participants will undergo blood samplings, urine collections, physical/neurological examinations, and clinical evaluations. Participants will also need to complete questionnaires throughout the study. The total study duration for a participant will be up to 40 weeks (approximately 9 months).
Trial Details
NCT Number NCT06937931
Lead Sponsor Ipsen
Conditions Cervical Dystonia
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov