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

NCT06937931 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of the study drug, 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. IPN10200 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 IPN10200 Dose A or Dose B (additional participants may receive IPN10200 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).

Conditions

  • Cervical Dystonia

Interventions

BIOLOGICAL

IPN10200

Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.

OTHER

Placebo

Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-03-26
Completion
2027-11-05
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06937931 on ClinicalTrials.gov