Pain in Parkinson's Disease With Motor Fluctuations.

NCT03648671 | Unknown DMC

• 1 other identifier: 1470CESC
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Pain (spontaneous pain) is a fundamental non-motor symptom (NMS) of Parkinson's disease (PD) that is prevalent throughout the condition and often unrecognized and undertreated. The study of the scalp laser-evoked potentials (LEPs) (evoked pain) allows a non-invasive exploration of pain central pathways in humans. This technique proved useful in elucidating the physiopathology underlying different pain syndromes. This study has been conceived to study spontaneous pain (and/or evoked pain by laser stimulation) in PD patients (with or without pain) with motor fluctuations under drugs-on (Safinamide Metansolfonato or Rasagilina Mesilato).

Conditions

Parkinson Disease

Keywords

Safinamide; Pain; Parkinson

Outcome Measures

Primary Outcomes (4)

• Latency (ms) of N1/P1 complex.

  Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.

  Change from baseline at 12 weeks

• Latency (ms) of N2/P2 complex.

  Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.

  Change from baseline at 12 weeks

• Amplitude (microvolt) of N1/P1 complex.

  Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.

  Change from baseline at 12 weeks

• Amplitude (microvolt) of N2/P2 complex.

  Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.

  Change from baseline at 12 weeks

Secondary Outcomes (25)

• Body localization

  Change from baseline at 12 weeks

• King's Pain Scale for Parkinson's Disease

  Change from baseline at 12 weeks

• Italian version of the brief pain inventory short form

  Change from baseline at 12 weeks

• Clinical global impression of change

  Change from baseline at 12 weeks

• The 39-Item Parkinson's Disease Questionnaire (PDQ-39)

  Change from baseline at 12 weeks

Study Arms (4)

PD with PAIN

12 patients will undergo add-on drugs therapy with safinamide metansolfonato.

Drug: safinamide metansolfonato (12 weeks)

PD without PAIN

12 patients will undergo add-on drugs therapy with safinamide metansolfonato.

Drug: safinamide metansolfonato (12 weeks)

PD with PAIN rasagilina

12 patients will undergo add-on drugs therapy with rasagilina mesilato.

Drug: rasagilina mesilato (12 weeks)

PD without PAIN rasagilina

12 patients will undergo add-on drugs therapy with rasagilina mesilato.

Drug: rasagilina mesilato (12 weeks)

Interventions

safinamide metansolfonato (12 weeks) DRUG

safinamide metansolfonato

PD with PAIN

rasagilina mesilato (12 weeks) DRUG

rasagilina mesilato

PD with PAIN rasagilina

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males or females patients with mid-to-late PD aged 30 to 80 years with or without chronic pain symptoms (duration \>3 months) and motor fluctuations while receiving L-dopa alone or with other dopaminergic treatments.

You may qualify if:

• PD patients with or without pain willing to participate in this study and able to sign the written informed consent
• To be included in the PD with pain group, the patient's intensity of pain must be moderate to severe over the last month, as reported by a numerical rating scores (NRS≥4) despite the optimal dopaminergic treatment
• No modification of dopaminergic drugs and analgesic therapy with FANS during the 28 days before starting the enrollment in this study.
• Diagnosis of idiopathic PD of ≥3 years duration
• Hoehn and Yahr stage I-III during OFF time
• Motor fluctuations (\>1.5 hours' OFF time/day)
• Patients who would have been treated with add-on therapy irrespective to the present protocol

You may not qualify if:

• Patients under (or with previous assumptions) monoamine oxidase inhibitor therapy.
• Late-stage PD experiencing severe, disabling peak-dose or biphasic dyskinesia, or unpredictable or widely swinging symptom fluctuations
• "de novo" patients, patients in early stage or non-fluctuating patients
• Evidence of dementia (MMSE \<24)
• Sign and symptoms suggestive of atypical parkinsonism
• Major psychiatric illnesses
• Severe and progressive medical illnesses
• Concomitant diseases potentially causing acute or chronic pain (i.e., rheumatologic conditions, severe polyneuropathy, and spine injuries)
• Treatments with tri-tetracyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), opioids, neuroleptics, barbiturates and phenothiazines, pregabalin and gabapentin
• Any type of retinopathy

Sponsors & Collaborators

• Universita di Verona: lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (1)

Azienda ospedaliera universitaria integrata verona

Verona, 37126, Italy

RECRUITING

Related Publications (5)

• Defazio G, Berardelli A, Fabbrini G, Martino D, Fincati E, Fiaschi A, Moretto G, Abbruzzese G, Marchese R, Bonuccelli U, Del Dotto P, Barone P, De Vivo E, Albanese A, Antonini A, Canesi M, Lopiano L, Zibetti M, Nappi G, Martignoni E, Lamberti P, Tinazzi M. Pain as a nonmotor symptom of Parkinson disease: evidence from a case-control study. Arch Neurol. 2008 Sep;65(9):1191-4. doi: 10.1001/archneurol.2008.2.

  PMID: 18779422 BACKGROUND

• Tinazzi M, Recchia S, Simonetto S, Tamburin S, Defazio G, Fiaschi A, Moretto G, Valeriani M. Muscular pain in Parkinson's disease and nociceptive processing assessed with CO2 laser-evoked potentials. Mov Disord. 2010 Jan 30;25(2):213-20. doi: 10.1002/mds.22932.

  PMID: 20063386 BACKGROUND

• Tinazzi M, Recchia S, Simonetto S, Defazio G, Tamburin S, Moretto G, Fiaschi A, Miliucci R, Valeriani M. Hyperalgesia and laser evoked potentials alterations in hemiparkinson: evidence for an abnormal nociceptive processing. J Neurol Sci. 2009 Jan 15;276(1-2):153-8. doi: 10.1016/j.jns.2008.09.023. Epub 2008 Oct 26.

  PMID: 18954878 BACKGROUND

• Tinazzi M, Del Vesco C, Defazio G, Fincati E, Smania N, Moretto G, Fiaschi A, Le Pera D, Valeriani M. Abnormal processing of the nociceptive input in Parkinson's disease: a study with CO2 laser evoked potentials. Pain. 2008 May;136(1-2):117-24. doi: 10.1016/j.pain.2007.06.022. Epub 2007 Aug 31.

  PMID: 17765400 BACKGROUND

• Zambito-Marsala S, Erro R, Bacchin R, Fornasier A, Fabris F, Lo Cascio C, Ferracci F, Morgante F, Tinazzi M. Abnormal nociceptive processing occurs centrally and not peripherally in pain-free Parkinson disease patients: A study with laser-evoked potentials. Parkinsonism Relat Disord. 2017 Jan;34:43-48. doi: 10.1016/j.parkreldis.2016.10.019. Epub 2016 Oct 24.

  PMID: 27836714 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Pain

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Tinazzi, MD, PhD

  Azienda Ospedaliera Universitaria Integrata Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Tinazzi, MD, PhD

CONTACT

0458027472; michele.tinazzi@univr.it

Christian Geroin, PhD

CONTACT

0458027472; christian.geroin@univr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor of Neurology

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 27, 2018
• Study Start: March 28, 2018
• Primary Completion: March 28, 2019
• Study Completion: November 30, 2019
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

IT (1)