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Effect of Safinamide on Parkinson's Disease Related Chronic Pain

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ClinicalTrials.gov Identifier: NCT03841604
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zambon SpA

Brief Summary:

This is a Phase IV, international, multicentre, randomised, double-blind, placebo controlled study in IPD patients, experiencing motor fluctuations and PD related chronic pain while on stable doses of levodopa (L-Dopa).

Participants will be randomized 2:1 to receive either active or placebo


Condition or disease Intervention/treatment Phase
Idiopathic Parkinson Disease Drug: Safinamide Methanesulfonate Drug: Safinamide methanesulfonate matching placebo Phase 4

Detailed Description:

This is an international, multicentre, randomised, double-blind, placebo-controlled study.

Patients will be randomized 2:1 to receive either active and placebo Approximately 220 participants will be screened, of which 177 will be enrolled Study participation will be up to a maximum duration of 19 weeks and will comprise a screening period (1 to 2 weeks) and a treatment period (16 weeks). A telephone follow-up call will be performed 1 week after the end of treatment


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : June 28, 2020
Estimated Study Completion Date : June 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Safinamide

Arm Intervention/treatment
Experimental: Experimental
Safinamide methanesulfonate film coated tablets once daily
Drug: Safinamide Methanesulfonate
50 mg, 100 mg

Placebo Comparator: Placebo
Safinamide methanesulfonate matching placebo film coated tablets once daily
Drug: Safinamide methanesulfonate matching placebo
50 mg, 100 mg




Primary Outcome Measures :
  1. To evaluate the potential efficacy of safinamide 100 mg od, compared to placebo, as add-on therapy, for PD related chronic pain: Numerical Rating Scale (NRS) [ Time Frame: 16 weeks ]

    Change in pain severity ("average worst pain experienced in the last 7 days"), as assessed by an 11-point Numerical Rating Scale (NRS).

    [0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain]



Secondary Outcome Measures :
  1. Percentage of pain responders [ Time Frame: 16 weeks ]
    Reduction in pain severity of ≥2 points ("average worst pain experienced in the last 7 days") as assessed by an 11-point NRS, compared to baseline [0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain]

  2. Clinical Global Impression for pain (change) [ Time Frame: 16 weeks ]
    Change in the CGI-C (Clinical Global Impression - Change) score for pain [ a seven-point scale, it ranges from Very much Improved to Very much Worse]

  3. Clinical Global Impression for pain (severity) [ Time Frame: 16 weeks ]
    The CGI-S (Clinical Global Impression - Severity) score for pain at week 16 [ a seven-point scale, it ranges from Very much Better to Very much Worse]

  4. Patient Global Impression for pain [ Time Frame: 16 weeks ]

    Change in the PGI-C (Patient Global Impression - Change) score for pain

    [ a seven-point scale, it ranges from Very much Better to Very much Worse]


  5. Reduction of pain drugs (Percentage) [ Time Frame: 16 weeks ]
    Percentage of reduction in number of concomitant pain drugs

  6. Reduction of pain drugs (amount) [ Time Frame: 16 weeks ]
    Amount of PRN pain medication

  7. Reduction of pain drugs [ Time Frame: 16 weeks ]
    Number of patients with at least one intake of PRN pain medication.

  8. Mood [ Time Frame: 16 weeks ]

    Change in the Hospital Anxiety and Depression Scale (HADS) score

    [Fourteen item scale, seven items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains]


  9. Dyskinesia [ Time Frame: 16 weeks ]

    Change in the MDS-UPDRS (total score and subscores)

    [The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living, Part III (motor examination) and Part IV (motor complications)]




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant must be 30 years of age or older, at the time of signing the informed consent.
  2. Diagnosed with IPD by using the United Kingdom Parkinson's Disease Society Brain Bank criteria for more than 5 years duration.
  3. Receiving treatment with a stable dose of oral L-Dopa (including controlled release [CR], immediate release [IR] or a combination of CR/IR), with and without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor and may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine for at least 4 weeks prior to the randomisation (baseline visit).
  4. Hoehn and Yahr stage between 2-3 (inclusive) during the "ON" phase at the screening visit.
  5. Experiencing motor fluctuations following optimum titration of treatment medications and within the 4 weeks immediately prior to randomisation.
  6. Experiencing a minimum of 2.0 hours/day of "OFF" time during the day (excluding morning akinesia).
  7. Experiencing chronic pain (i.e. ongoing for ≥3 months prior to screening visit); the Investigator must consider chronic pain directly related to PD and not explained by any other health problem (e.g. peripheral neuropathy, organ disease or arthritis pain) OR consider the intensity of chronic pain specifically aggravated by PD.
  8. On a stable treatment regimen of analgesics in the 4 weeks prior to the randomisation visit.
  9. Able to maintain an accurate and complete electronic diary with the help of a caregiver.
  10. Male or female

    •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i.Not a woman of childbearing potential (WOCBP) OR ii.A WOCBP who agrees to follow the contraceptive guidance

  11. Capable of giving signed informed consent

Exclusion Criteria:

  1. Any form of Parkinsonism other than IPD.
  2. Diagnosis of chronic migraine (>15 days per month) or cancer pain.
  3. History of bipolar disorder, depression, schizophrenia or other psychotic disorder requiring treatment with neuroleptics.
  4. History of dementia or cognitive dysfunction.
  5. Severe, peak dose or biphasic dyskinesia.
  6. Unpredictable or widely swinging fluctuations.
  7. Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease.
  8. Moderate or severe liver failure using the Child-Pugh classification score.
  9. History of drug and/or alcohol abuse within 12 months prior to screening as defined by the current edition of the Diagnostic and Statistical Manual of Mental Disorders.
  10. Allergy/sensitivity or contraindications to the IMPs or their excipients, anticonvulsants, L-dopa or other anti-Parkinsonian drugs
  11. Treatment with monoamine oxidase inhibitors (MAOIs), levodopa infusion, pethidine, fluoxetine, fluvoxamine less than 4 weeks prior to the randomisation visit
  12. Use of any investigational drug or device within 30 days prior to screening or 5 half-lives, whichever is the longest, or participation in a previous trial with safinamide or previous treatment with safinamide
  13. Mini-Mental State Exam (MMSE) total score <24 at screening.
  14. NRS score ≤ 4 points at randomization visit.
  15. Any clinically significant condition which, in the opinion of the Investigator, would not be compatible with study participation or represent a risk for participants while in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841604


Contacts
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Contact: Viviana Tubazio +39 026652.4414 viviana.tubazio@zambongroup.com
Contact: Luca Raiteri +39 026652.4624 luca.raiteri@zambongroup.com

Locations
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Austria
Zambon Investigative Site Not yet recruiting
Innsbruck, Austria, 6020
Zambon Investigative site Not yet recruiting
Wien, Austria, 1220
France
Zambon Investigative Site Not yet recruiting
Clermont-Ferrand, France, 63000
Zambon Investigative Site Not yet recruiting
Grenoble, France, 38700
Zambon Investigative Site Not yet recruiting
Marseille, France, 13385
Zambon Investigative Site Not yet recruiting
Nîmes, France, 30900
Zambon Investigative Site Not yet recruiting
Strasbourg, France, 67200
Zambon Investigative Site Not yet recruiting
Toulouse, France, 31300
Germany
Zambon Investigative Site Not yet recruiting
Berlin, Germany, 13088
Zambon Investigative Site Not yet recruiting
Dresde, Germany, 01307
Zambon Investigative Site Not yet recruiting
Essen, Germany, 45257
Zambon Investigative Site Not yet recruiting
Gera, Germany, 07551
Zambon Investigative Site Not yet recruiting
Haag, Germany, 83527
Zambon Investigative Site Not yet recruiting
Ulm, Germany, 89081
Italy
Zambon Investigative Site Not yet recruiting
Chieti, Italy, 66013
Zambon Investigative Site Not yet recruiting
Milano, Italy, 20126
Zambon Investigative Site Not yet recruiting
Pisa, Italy, 56124
Zambon Investigative Site Not yet recruiting
Roma, Italy, 00148
Zambon Investigative Site Not yet recruiting
Roma, Italy, 00163
Zambon Investigative Site Not yet recruiting
Salerno, Italy, 84084
Spain
Zambon Investigative Site Recruiting
Barcelona, Spain, 08025
Zambon Investigative Site Not yet recruiting
Cadiz, Spain, 11009
Zambon Investigative Site Recruiting
Donostia, Spain, 20014
Zambon Investigative Site Recruiting
Madrid, Spain, 28006
Zambon Investigative Site Recruiting
Madrid, Spain, 28046
Zambon Investigative Site Recruiting
Pamplona, Spain, 31008
Zambon Investigative Site Not yet recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Zambon SpA

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Responsible Party: Zambon SpA
ClinicalTrials.gov Identifier: NCT03841604     History of Changes
Other Study ID Numbers: Z7219M01
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms