PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets

NCT00491998 | Completed Phase 1

• 1 other identifier: V1512-2PD01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• to characterise the plasma concentrations of L-dopa after repeated doses of V1512 in fluctuating PD patients compared to standard L-dopa/carbidopa (Sinemet) over the course of the day

  4 weeks

Secondary Outcomes (2)

• correlate plasma concentrations with response to therapy;

  4 weeks

• further characterise the safety and tolerability profile for each treatment

  4 weeks

Study Arms (3)

2-hourly dosing

EXPERIMENTAL

6 Doses of IMP at 2-hourly intervals

Drug: V1512

3-hourly dosing

EXPERIMENTAL

4 doses of IMP at 3-hourly intervals

Drug: V1512

3-hourly dosing plus Entacapone

ACTIVE COMPARATOR

4 doses of IMP plus Entacapone at 3-hourly intervals

Drug: V1512 and Entacapone

Interventions

V1512 DRUG

6 doses of IMP at 2-hourly intervals

2-hourly dosing

V1512 and Entacapone DRUG

4 doses of IMP and Entacapone at 3-hourly intervals

3-hourly dosing plus Entacapone

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \>30 years of age of any race;
• A Body Mass Index between 18.5 and 29.9 kg/m2 (inclusive);
• Clinical diagnosis according to the Brain Bank diagnostic criteria of idiopathic Parkinson's Disease (2 of 3 cardinal symptoms - bradykinesia, rigidity, tremor -must be present, with a positive response to L-dopa);
• Presence of fluctuations in motor performance with \>2 hours inclusive of daytime OFF episodes (not applicable for cohort 1 patients);
• At least 1 hour delay to ON time with afternoon doses;
• Discontinued use of COMT inhibitors (cathecol-o-methyl transferase) for at least 2 weeks prior to study entry (not applicable for cohort 3 patients);
• Stable doses of dopamine agonists or selegiline for at least 2 weeks before entry into the study;
• Stable comorbidity for 4 weeks;
• Female patients must be of non-childbearing potential (post-menopausal or physically incapable of childbearing);
• Willing and able to give informed consent according to national legal requirements prior to initiation of any study-related procedures

You may not qualify if:

• Clinically relevant abnormal vital sign values or safety laboratory data.
• Patients who smoke and are unable to refrain from smoking during the in-clinic period
• Diagnosis of atypical parkinsonism;
• A history and/or the presence of gastro-intestinal disorders (or surgery) that could interfere with absorption of the test medication;
• A history of intolerance or clinically relevant allergy to L-dopa and/or carbidopa taken in any formulation or combination;
• A history of intolerance or clinically relevant allergy to entacapone or any ingredients of Comtan (cohort 3 patients only)
• Any other condition which, in the opinion of the Investigator, would interfere with optimal participation in the study e.g. inability to complete patient diary;
• Participation in any clinical study or receiving treatment with another investigational drug within 30 days or 5 half lives (whichever is longer) before the screening visit;
• Blood donation within 3 months before study participation;
• History of neuroleptic malignant syndrome (NMS) or NMS-like syndromes, or non-traumatic rhabdomyolysis;
• Patients taking non-selective MAO inhibitors;
• Patients with a history of, or clinical indication of, narrow angle glaucoma;
• Patients with a history of, or clinical indication of, malignant melanoma;
• Patients with a history of, or clinical indication of, depression or psychosis;
• Patients taking iron containing medications (ferrous sulphate, ferrous gluconate)

Sponsors & Collaborators

• Vernalis (R&D) Ltd: lead
• Cita NeuroPharmaceuticals: collaborator
• Syneos Health: collaborator

Study Sites (1)

IRCCS San Raffaele Pisana

Roma, Rome, 00163, Italy

Location

Related Publications (1)

• Stocchi F, Vacca L, Grassini P, Pawsey S, Whale H, Marconi S, Torti M. L-Dopa Pharmacokinetic Profile with Effervescent Melevodopa/Carbidopa versus Standard-Release Levodopa/Carbidopa Tablets in Parkinson's Disease: A Randomised Study. Parkinsons Dis. 2015;2015:369465. doi: 10.1155/2015/369465. Epub 2015 Jun 10.

  PMID: 26171276 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

entacapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Fabrizio Stocchi, MD, PhD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

IT (1)