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Idiopathic Parkinson DiseasePhase 4NCT03841604

Effect of Safinamide on Parkinson's Disease Related Chronic Pain

A Phase 4 study testing Safinamide Methanesulfonate in people with Idiopathic Parkinson Disease, run by Zambon SpA at 45 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary objective: To evaluate the potential efficacy of safinamide 100 mg once daily (OD), compared with placebo, as add-on therapy for PD-related chronic pain Secondary objectives: Percentage of pain responders Clinical Global Impression for pain Patient Global Impression for pain Reduction in use of pain drugs Mood… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Idiopathic Parkinson Disease
What is being tested?
Safinamide Methanesulfonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
45 sitesin 5 countries
Study dates
9 Apr 2019to 3 May 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be 30 years of age or older, at the time of signing the informed consent.
  • Diagnosed with IPD by using the United Kingdom Parkinson's Disease Society Brain Bank criteria for more than 5 years duration.
  • 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).
  • Hoehn and Yahr stage between 2-3 (inclusive) during the "ON" phase at the screening visit.
  • Experiencing motor fluctuations following optimum titration of treatment medications and within the 4 weeks immediately prior to randomisation.
  • 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.
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  • If taking regular analgesics, the treatment regimen should be stable in the 4 weeks prior to the randomisation visit.
  • Able to maintain an accurate and complete electronic diary with the help of a caregiver.
  • 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
  • Capable of giving signed informed consent

Who cannot join

  • Any form of Parkinsonism other than IPD.
  • Diagnosis of chronic migraine (>15 days per month) or cancer pain.
  • History of bipolar disorder, depression, schizophrenia or other psychotic disorder requiring treatment with neuroleptics.
  • History of dementia or cognitive dysfunction.
  • Severe, peak dose or biphasic dyskinesia.
  • Unpredictable or widely swinging fluctuations.
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  • 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.
  • Moderate or severe liver failure using the Child-Pugh classification score.
  • 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.
  • Allergy/sensitivity, intolerance or contraindications to Safinamide.
  • Treatment with monoamine oxidase inhibitors (MAOIs), levodopa infusion, pethidine, fluoxetine, fluvoxamine less than 4 weeks prior to the randomisation visit
  • Use of any investigational drug or device within 30 days prior to screening or 5 half-lives, whichever is the longest
  • Previous treatment with Safinamide in the 9 months before the screening visit
  • Mini-Mental State Exam (MMSE) total score <24 at screening.
  • NRS score ≤ 4 points at randomization visit.
  • 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

Trial locations and contacts

45 sites in 5 countries.

45 sites in 5 countries

Spain16 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 08035

  • C.A.U de Burgos - Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital Puerta del Mar

    Cadiz, 11009

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital HM Puerta del Sur

    Móstoles, 28938

  • Clinica Universidad Navarra

    Pamplona, 31008

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy11 sites

  • Zambon Investigative Site

    Chieti, 66013

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Centro per la Malattia di Parkinson e i Disturbi del Movimento

    Milan, 20126

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, 20133

  • Azienda Ospedaliera Di Perugia

    Perugia

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, 86077

  • Fondazione PTV Policlinico Tor Vergata

    Roma, 00133

  • Ospedale San Giovanni Battista - ACISMOM

    Roma, 00148

  • IRCCS San Raffaele Pisana

    Roma, 00163

  • Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

    Salerno, 84084

Other trials in Italy

Germany10 sites

  • St. Joseph Krankenhaus Berlin

    Berlin, 13088

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307

  • Katholische Kliniken Ruhrhalbinsel GmbH

    Essen, 45257

  • Neurologische Praxis

    Gera, 07551

  • University Medicine Göttingen Germany

    Göttingen, 37075

  • Klinik Haag i. OB

    Haag, 83527

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35043

  • Universitätsklinikum Münster

    Münster, 48149

  • NeuroPoint Akademie

    Ulm, 89073

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

France6 sites

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63000

  • CHU de GRENOBLE

    Grenoble, 38700

  • Hopitaux de La Timone

    Marseille, 13385

  • Centre Hospitalier Universitaire de Nimes

    Nîmes, 30900

  • Hopital de Hautepierre

    Strasbourg, 67200

  • Hôpital Pierre-Paul Riquet

    Toulouse, 31300

Other trials in France

Austria2 sites

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

  • Institut für Neuroimmunologische und Neurodegenerative Erkrankungen

    Vienna, 1220

Other trials in Austria

About this study

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

Primary objective:

  • To evaluate the potential efficacy of safinamide 100 mg once daily (OD), compared with placebo, as add-on therapy for PD-related chronic pain

Secondary objectives:

  • Percentage of pain responders
  • Clinical Global Impression for pain
  • Patient Global Impression for pain
  • Reduction in use of pain drugs
  • Mood
  • Motor and non-motor symptoms

Safety Objectives:

  • Safety and tolerability
Read the detailed description

This is a Phase IV, international, multicentre, randomised, double-blind, placebo controlled study in idiopathic Parkinson's disease (IPD) patients, experiencing motor fluctuations and PD-related chronic pain while on stable doses of levodopa (L-Dopa), to Evaluate the Efficacy and Safety of Safinamide 100 mg Once Daily, as Add-On Therapy.

The study consisted of:

  • A screening period of up to 1 to 2 weeks.
  • A treatment period of 16 weeks.
  • A telephone follow-up call at 1 week after the end of treatment. Eligible subjects were randomly assigned in a ratio of 2:1 to receive either safinamide (50 mg or 100 mg) or matching placebo. At Day 1, eligible subjects entered the treatment period to receive safinamide 50 mg (from Day 1 to Day 7) and then 100 mg (from Day 8 onwards) orally OD. After completion of all baseline assessments, subjects received the first dose of study drug at the study center and, thereafter, study drug was to be taken at home each morning along with their first morning dose of L-DOPA and other (if any) PD medications. On Day 8, the dose of study drug was increased, at home, to 100 mg OD. Each subject received treatment for 16 weeks, with visits at Week 0/Day 1 (baseline) and at Weeks 4, 8, and 16 (or early termination). From Day 1 onwards, subjects recorded the use of as-needed (PRN) medications along with indicating the worst pain they experienced on a daily basis.
Being tested
Safinamide Methanesulfonate, Safinamide methanesulfonate matching placebo
Keywords
Parkinson disease, Safinamide
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Safinamide MethanesulfonateDrug

    Also called Xadago

    50 mg, 100 mg

  • Safinamide methanesulfonate matching placeboOther

    Also called Placebo

    50 mg, 100 mg

Study groups in NCT03841604
Study groupRoleWhat they receive
ExperimentalExperimentalSafinamide methanesulfonate film coated tablets once daily, 50 mg and 100 mg. Safinamide methanesulfonate 50 mg and 100 mg tablets was administered orally, OD, with or without food, at breakfast time when the subject was taking their morning dose of L-DOPA. Subjects received study drug 50 mg (from Day 1 to Day 7) and then 100 mg (from Day 8 onwards). The dose of 100 mg/day (titrated from 50 mg/day after 1 week) was selected based on the results of previous studies in patients with PD and from the results of a post hoc analysis that investigated the effects of safinamide on pain.
Receives: Drug: Safinamide Methanesulfonate
PlaceboPlacebo comparatorSafinamide methanesulfonate matching placebo film coated tablets once daily. The matching placebo was administered orally, OD, in tablets, with or without food, at breakfast time when the subject was taking their morning dose of L-DOPA.
Receives: Other: Safinamide methanesulfonate matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 16 in Pain Severity (NRS-11 Scale) - Full Analysis Set

    To evaluate the potential efficacy of safinamide 100 (mg od), compared to placebo, as add-on therapy, for change pain severity ("average worst pain experienced in the last 7 days"), as assessed by an 11-point Numerical Rating Scale (NRS). Based on this scale, 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.

    Measured: Baseline and Week 16

  2. Change From Baseline to Week 16 in Pain Severity (NRS-11 Scale) - Per Protocol Set

    To evaluate the potential efficacy of safinamide 100 (mg od), compared to placebo, as add-on therapy, for change pain severity ("average worst pain experienced in the last 7 days"), as assessed by an 11-point Numerical Rating Scale (NRS). Based on this scale, 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.

    Measured: Baseline and Week 16

Secondary outcomes (9)

  1. Number of Subjects With a Reduction of ≥2 Points in Pain Severity at Week 16, Compared to Baseline

    Reduction in pain severity (based on the "average worst pain experienced in the last 7 days") of ≥ 2 points was assessed by an 11-point NRS (numerical rating scale), compared to baseline. Based on this scale, 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.

    Measured: Week 16

  2. The Change From Baseline to Week 16 in the Clinical Global Impression of Change (CGI-C) Score for Pain

    CGI-C (Clinical Global Impression - Change) score for pain is a seven-point scale that indicates the patient's impression of change for relevant symptoms. It ranges from "substantial improvement" to "substantial worsening":

    1. = substantial improvement;
    2. = moderate improvement;
    3. = minimum improvement;
    4. = No change;
    5. = Minimum worsening;
    6. = moderate worsening;
    7. = substantial worsening. of course the higher the score, the worse the outcome.

    Measured: Baseline and Week 16

  3. The Global Impression of Severity (CGI-S) Score for Pain at Week 16

    The CGI-S (Clinical Global Impression - Severity) score is a seven-point scale which asks the clinician one question: "considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated as follow:

    1. = normal, not at all ill;
    2. = borderline mentally ill;
    3. = mildly ill;
    4. = moderately ill;
    5. = markedly ill;
    6. = severely ill;
    7. = among the most severely ill patients. of course the higher the score, the worse the outcome.

    Measured: Baseline and Week 16

  4. The Change From Baseline to Week 16 in the Patient Global Impression of Change (PGI-C) Score for Pain

    The Patients' Global Impression of Change (PGI-C) scale is designed to capture the subject's perception of change in activity limitations, symptoms, emotions, an overall quality of life. These areas are captured using a 7- point scale, indicating:

    1. = no change (or condition has got worse);
    2. = almost the same, hardly any change at all;
    3. = a little better, but not noticeable change;
    4. = somewhat better, but the change has not made any real difference;
    5. = moderately better, and a slight but noticeable change;
    6. = better and a definite improvement that has made a real and worthwhile difference;
    7. = a great deal better, and a considerable improvement that has made all the difference.

    Of course, the higher the score, the better the outcome.

    Measured: Baseline and Week 16

  5. Number of Subjects With Concomitant Use of Pain Drugs at Different Timepoints

    This outcome describes the number of subjects which had concomitant assumption of pain drugs at different timepoints.

    Measured: Baseline, weeks 4, 8 and 16

  6. Amount of PRN PD Pain Medication: Count of Subjects Who Used PRN PD Pain Medication in the 7 Days Preceding Visits

    Total count of patients who used PRN (meaning "when necessary") Parkinson's Disease Pain Medications was expressed both in number and in percentage.

    The analysis of amount of concomitant PRN PD pain medications as reported in the subject diary was summarized:

    • as the number of subjects who were taking pain medication in the 7 days preceding visits at different timepoints;
    • in the number of days on which PRN PD pain medication was taken at different timepoints.

    Measured: at Baseline and weeks 4, 8 and 16

  7. Amount of PRN PD Pain Medication: Number of Days on Which PRN PD Pain Medication Was Taken at Different Timepoints

    The analysis of amount of concomitant PRN PD pain medications as reported in the subject diary was summarized:

    • as the number of days on which PRN PD pain medication was taken at different timepoints.
    • as the number of subjects who were taking pain medication in the 7 days preceding visits at different timepoints.

    Measured: At Baseline and weeks 4, 8 and 16

  8. Change From Baseline to Week 16 in the Hospital Anxiety and Depression Scale (HADS) Score

    The Hospital Anxiety and Depression Scale (HADS) was devised to measure anxiety and depression in a general medical population of patients through a unique questionnaire which takes 2-5 min to be completed. The questionnaire consists of a total of 14 items: seven items for the anxiety subscale (HADS Anxiety) and seven items for the depression subscale (HADS Depression). HADS Anxiety focus mainly on symptoms of generalized anxiety disorder and HADS Depression is focused on anhedonia, the main symptom of depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for anxiety subscale and the same for depression subscale, where:

    0-7 = Normal 8-10 = Borderline abnormal (borderline case). 11-21 = Abnormal (case) The two subscores are then summed up to obtain a total Hospital Anxiety and Depression Scale (HADS). The total scale range is 0-42. The higher the score, the worse the anxiety/depression status.

    Measured: Baseline and Week 16

  9. The Change From Baseline to Week 16 in MDS-UPDRS

    Change in the MDS-UPDRS = Movement Disorder Society-Unified Parkinson's Disease Rating Scale The MDS-UPDRS is defined by 4 Parts, each composed by a different number of items. Each item is rated on a 5-point Likert-type scale (ranging from 0 to 4); Part I (non-motor experiences of daily living; 13 items) Part II (motor experiences of daily living;13 items) Part III (motor examination; 33 items) Part IV (motor complications; 6 items) The MDS-UPDRS has a minimum score of 0 and a maximum score of 260. The higher the score, the more severe the impairment.

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start9 Apr 2019
  3. Primary completion30 Apr 2021
  4. Study completion3 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841604
Sponsor's protocol ID
Z7219M01
Other IDs
2017-002426-20, 2017
Status last verified
May 2020
First submitted
30 Jan 2019
Last updated
22 May 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Safinamide Methanesulfonate in people with Idiopathic Parkinson Disease, run by Zambon SpA at 45 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Spain, Italy, Germany, France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 16 in Pain Severity (NRS-11 Scale) - Full Analysis Set (time frame: Baseline and Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03841604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.

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