IPN10200 for Cervical Dystonia

(CATALPA Trial)

Recruiting at 50 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ipsen

Disqualifiers: Severe dysphagia, Anterocollis, Retrocollis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 36 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, IPN10200, to determine if it treats Cervical Dystonia (CD) more effectively than a placebo. CD causes neck pain, stiffness, and headaches, with current treatments lasting about three months. The trial will investigate whether IPN10200 can provide longer-lasting relief. Participants will receive varying doses of the drug or a placebo to identify the most effective option. The trial seeks adults with moderate to severe CD symptoms affecting the head, neck, and shoulders. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that some medications can be continued if details are recorded. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that IPN10200 is likely to be safe for humans?

Research has shown that IPN10200 was safe in earlier studies. These studies found that IPN10200 significantly reduced facial lines compared to a placebo, with no major safety issues reported. This indicates the treatment is generally well-tolerated by patients.

IPN10200 is now in Phase 2 trials for cervical dystonia, meaning its basic safety has already been confirmed in earlier research. This phase focuses on assessing its effectiveness and further evaluating safety. Participants report any side effects, helping researchers ensure the treatment's safety for future use.

Overall, while more information is always helpful, current findings suggest IPN10200 is safe for people, with no major side effects reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

IPN10200 is unique because it introduces a new approach to treating cervical dystonia by utilizing different dosing strategies not commonly seen in current treatments like botulinum toxin injections. Unlike the standard of care, which typically focuses on temporarily paralyzing muscles, IPN10200 aims to offer varying levels of muscle relaxation through its distinct dosing options, potentially optimizing effectiveness and minimizing side effects. Researchers are excited because this flexibility in dosing might better cater to individual patient needs, potentially offering more personalized and effective management of symptoms.

What evidence suggests that IPN10200 might be an effective treatment for Cervical Dystonia?

Research has shown that IPN10200 yields promising results for conditions like Cervical Dystonia. In studies on cosmetic issues such as frown lines, IPN10200 outperformed a placebo and other treatments like Dysport, with effects lasting longer. Patients noticed improvements as early as Week 4, and the effects persisted longer than traditional treatments. Although these results pertain to different uses, the longer-lasting effects suggest that IPN10200 might offer extended relief for Cervical Dystonia, which typically requires frequent treatments. This potential for prolonged relief is why researchers are further studying it for Cervical Dystonia. Participants in this trial will receive varying doses of IPN10200 or a placebo to assess its effectiveness and duration of relief for Cervical Dystonia. ^{1 2 3 6 7}

Who Is on the Research Team?

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

Adults with Cervical Dystonia, a condition causing neck pain and stiffness, can join this trial. They must have certain scores on the Toronto Western Spasmodic Torticollis Rating Scale indicating severity and pain. People who've never had or are used to BoNT therapy for CD may participate.

Inclusion Criteria

I experience pain from my condition.

My neck muscle spasms are severe.

My neck muscle spasms score is 20 or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive IPN10200 or placebo for 36 weeks with regular assessments

36 weeks

10 visits (in-person), 1 visit (remote), 12 visits for Dose C

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IPN10200

Trial Overview The study tests IPN10200's effectiveness in treating Cervical Dystonia compared to a placebo. Participants will receive one of two doses of IPN10200 or a placebo injected into muscles affecting their condition over a 36-week treatment period.

How Is the Trial Designed?

Group I: Group 2: Treatment Arm C Experimental Treatment 1 Intervention

IPN10200- Dose C

Group II: Group 1: Treatment Arm B Experimental Treatment 1 Intervention

IPN10200- Dose B

Group III: Group 1: Treatment Arm A Experimental Treatment 1 Intervention

IPN10200- Dose A

Group IV: Group 1: Placebo Comparator Placebo Group 1 Intervention

Placebo- Group1

Group V: Group 2: Placebo Comparator Placebo Group 1 Intervention

Placebo- Group 2

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06937931

A Study of IPN10200 for the Treatment of Cervical Dystonia ... 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 ...

2. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/ipsen-ipn10200-long-lasting-efficacy-lantic-trial-glabellar-lines

Ipsen's IPN10200 Demonstrates Long-Lasting Efficacy in ... IPN10200 demonstrated significant efficacy and longer duration versus placebo and Dysport in glabellar lines. · The treatment showed rapid onset, ...

3. ipsen.com ipsen.com/press-releases/ipsens-lantic-phase-ii-in-aesthetics-delivers-a-first-in-class-differentiated-long-acting-clinical-profile-for-ipn10200-enabling-the-initiation-of-phase-iii-3153621/

Ipsen's LANTIC Phase II in aesthetics delivers a first-in- ... Patients treated with IPN10200 showed a statistically significant improvement in response at Week 4 vs placebo (primary endpoint). A longer ...

4. trialx.com trialx.com/clinical-trials/listings/301143/a-study-of-ipn10200-for-the-treatment-of-cervical-dystonia-in-adults/

A Study of IPN10200 for the Treatment of Cervical Dystonia ... 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 ...

5. trial.medpath.com trial.medpath.com/news/eb0a373cd768b959/ipsen-s-ipn10200-shows-superior-long-term-efficacy-in-phase-ii-glabellar-lines-trial

Ipsen's IPN10200 Shows Superior Long-Term Efficacy in ... Ipsen's internally developed IPN10200 demonstrated statistically significant improvement in glabellar lines at Week 4 versus placebo in the ...

6. trial.medpath.com trial.medpath.com/clinical-trial/24cc743eb92cb4b5/2024-519248-34-00-ipn10200-cervical-dystonia-treatment

A study of IPN10200 for the treatment of cervical dystonia in ... To assess the efficacy of IPN10200 treatment compared to placebo in reducing Cervical Dystonia (CD) symptoms at Week 4 in adult participants.

7. clinicaltrials.eu clinicaltrials.eu/trial/study-on-ipn10200-for-treating-cervical-dystonia-in-adults/

Study on IPN10200 for Treating Cervical Dystonia in Adults The purpose of the study is to evaluate how well IPN10200 works in reducing the symptoms of cervical dystonia in adults. Participants in the study will receive ...