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Lenrispodun for treating motor fluctuations in Parkinson's Disease

A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

Phase 2 Interventional Intra-Cellular Therapies, Inc. · NCT05766813

This study is testing if a new medication called Lenrispodun can help people with Parkinson's Disease who have trouble with their movement control.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment132 (estimated)
Ages40 Years and up
SexAll
SponsorIntra-Cellular Therapies, Inc. Industry-sponsored
Locations31 sites (Phoenix, Arizona and 30 other locations)
Trial IDNCT05766813 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study evaluates the efficacy of Lenrispodun as an adjunctive therapy for patients with Parkinson's Disease who experience motor fluctuations, specifically wearing off symptoms and levodopa-induced dyskinesia. The study consists of a screening period to assess eligibility, followed by a 4-week double-blind treatment phase where participants receive either Lenrispodun or a placebo. After treatment, there is a 1-week safety follow-up period to monitor any adverse effects. The goal is to determine if Lenrispodun can improve motor function in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of Parkinson's Disease and experiencing motor fluctuations while on stable doses of levodopa.

Not a fit: Patients who are not on a stable dose of levodopa or those with advanced stages of Parkinson's Disease beyond Hoehn and Yahr stages 2 or 3 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce motor fluctuations and improve the quality of life for patients with Parkinson's Disease.

How similar studies have performed: Other studies have shown promise in using adjunctive therapies for managing motor fluctuations in Parkinson's Disease, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female between 40 years of age and older
2. Body mass index of 19.0-40.0 kg/m2;
3. Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;
4. Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;
5. Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:

   1. Have been on a stable and optimal dose of levodopa (levodopa + DDCI combination: minimum dose of levodopa equivalent to 100 mg three times daily) for at least 4 weeks prior to Screening, and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;
   2. If taking other anti-parkinsonian medications (MAO-B \[monoamine oxidase B\] inhibitor, COMT \[catechol-O-methyltransferase\] inhibitor, dopamine agonist) in addition to levodopa, have been on a stable dose for at least 4 weeks prior to Screening and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;

7\. Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment; 8. Properly complete and return a self-reported home diary for motor function status (Hauser Diary) during the Screening Period, which confirms 3 days (ie, 3 consecutive, 24-hour periods) immediately prior to Baseline, each with at least 2½ hours of OFF time during waking hours.

9\. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.

Exclusion Criteria:

1. Medical history indicating parkinsonism other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia;
2. Has late-stage PD, severe peak-dose dyskinesia, clinically significant end-dose or biphasic dyskinesia, and/or unpredictable or widely swinging fluctuations in their symptoms as assessed by the Investigator;
3. Exhibits clinical signs of dementia as indicated by the Mini-Mental State Examination, 2nd Edition: Standard Version (MMSE-2:SV) score of ≤ 24;
4. Use of moderate or strong CYP3A4 inhibitors within 5 half-lives of Baseline or CYP3A4 inducers within 2 weeks of Baseline;
5. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of acetylsalicylic acid (ASA);
6. Use of MAO-A inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, or alpha blockers including tamsulosin, within 5 half-lives of Baseline;

Where this trial is running

Phoenix, Arizona and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Parkinson Diseaselevodopa-induced dyskinesiaON and OFF state
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.