Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients (AMBLED)

• ClinicalTrials.gov Identifier: NCT03162874
• Recruitment Status: Recruiting
• First Posted: May 22, 2017
• Last Update Posted: March 6, 2019
• Sponsor: Prexton Therapeutics
• Information provided by (Responsible Party): Prexton Therapeutics

Study Description

Brief Summary:

This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Drug: Placebo oral capsule; Drug: PXT002331 - dose 1; Drug: PXT002331 - dose 2	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)
• Actual Study Start Date: July 4, 2017
• Estimated Primary Completion Date: September 15, 2019
• Estimated Study Completion Date: October 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: PLACEBO	Drug: Placebo oral capsule; BID
Experimental: PXT002331 - 10mg	Drug: PXT002331 - dose 1; Oral
Experimental: PXT002331 - 30mg	Drug: PXT002331 - dose 2; Oral

Outcome Measures

Primary Outcome Measures :

1. Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries [ Time Frame: 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Males or females diagnosed after the age of 30 years with idiopathic PD for at least 3 years
• Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
• Been treated with a stable regimen of levodopa-containing therapy
• Subjects who are on a long-acting formulation of levodopa-containing therapy, including Apodespan PR (or equivalent), must be on a stable dose for at least 6 weeks prior to the first screening visit
• Experienced motor fluctuations with wearing off over a period of at least 3 months prior to randomisation
• Experienced LID over a period of at least 3 months prior to randomisation
• Female subjects will be women of non-childbearing potential
• Subjects must pass a Hauser diary concordance test
• Subjects are able, with or without the help of a caregiver, to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use confidential health information in accordance with national and local subject privacy regulations

Exclusion Criteria:

• Subjects with atypical, secondary or drug-induced Parkinsonism
• Subjects with a Mini-Mental State Examination (MMSE) score <25
• Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma.
• Subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator.
• Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
• Subjects who have undergone prior neurosurgical operation for PD or transcranial magnetic stimulation.
• Subjects who are participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the baseline visit.
• Female subjects of childbearing potential
• Subjects who are pregnant (as determined by positive serum pregnancy test at screening and/or baseline), breastfeeding or lactating.
• Subjects who, in the opinion of the Investigator, should not participate in this study.

Contacts and Locations

Contacts

Contact: TRAN, MSc; +41227069010; AMBLED@lundbeck.com

  Show 49 Study Locations

Sponsors and Collaborators

Prexton Therapeutics

More Information

• Responsible Party: Prexton Therapeutics
• ClinicalTrials.gov Identifier: NCT03162874 History of Changes
• Other Study ID Numbers: PXT-CL17-001; 18023A ( Other Identifier: Lundbeck )
• First Posted: May 22, 2017
• Last Update Posted: March 6, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prexton Therapeutics:

Levodopa-Induced Dyskinesia (LID); Wearing-off; Foliglurax; Parkinson's Disease; mGluR4 PAM

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Levodopa; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs